Clinical Utility of Handheld Hydrogen Breathalyzer in Identification of Non-immune Mediated Food Sensitivities (AIRE Study)
Phase: NA
Conditions: SIBO, Small Bowel Bacterial Overgrowth Syndrome
Sponsor: Johns Hopkins University

NCT04309396 
 
Clinical Utility of Handheld Hydrogen Breathalyzer in Identification of Food Sensitivities 
(AIRE Study) 
 
Date: May 31st, 2022 
 

Date: May 31, 2022 
Principal Investigator: Glenn Treisman, MD 
Application Number: IRB00204104 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
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Johns Hopkins Medicine - eForm A 
Clinical utility of handheld hydrogen breathalyzer in identification of non-immune mediated food 
sensitivities 
1.
Abstract
Small intestinal bacterial overgrowth (SIBO) is defined as a condition in which an abnormally high amount
of coliform bacteria is present in the small bowel and results in premature anaerobic fermentation of
carbohydrates before reaching the colon. Commonly recognized causes include gastric achlorhydria, post-
surgical bowel stasis, gastrocolic/coloenteric fistulas, and motility disorders leading to bowel stasis. The
current “gold standard” for the diagnosis of SIBO, is a breath test that measures the concentration of 
hydrogen in response to lactulose, a carbohydrate that is only metabolized by bacteria. However, its 
accuracy is only about 50% and therefore it is not a very useful test, leading most physicians to treat these 
patients empirically based on clinical suspicion alone. The purpose of this study is to evaluate the clinical 
utility of a portable medical device called AIRE, an over-the-counter, commercially available handheld breath 
analyzer that measures exhaled hydrogen content.  
2.
Objectives (include all primary and secondary objectives)
Primary objective:
To examine the correlation between the results of the AIRE hydrogen and methane breathalyzer
and the lactulose hydrogen breath test (LHBT) when performed together in patients clinically
suspected to have SIBO.
Secondary objectives:
1. To examine the correlation between postprandial exhaled hydrogen and methane (H2) content
as measured over a 1-week period by AIRE on the patient’s usual diet at home and the results
of the standardized LHBT performed in the clinic
2. To examine the correlation between AIRE results and gastrointestinal symptoms suggestive of
SIBO.
3. To examine the response of hydrogen and methane breath concentrations using AIRE to
antibiotic treatment (in patients undergoing antibiotic treatment).
4. To assess the reproducibility of the AIRE results over several weeks in patients not undergoing
antibiotic treatment.
3.
Background (briefly describe pre-clinical and clinical data, current experience with procedures,
drug or device, and any other relevant information to justify the research)
Small intestinal bacterial overgrowth (SIBO) is defined as a condition in which an abnormally high
amount of coliform bacteria is present in the small bowel and results in premature anaerobic
fermentation of carbohydrates before reaching the colon.  Commonly recognized causes include
gastric achlorhydria (ie due to longstanding PPI use), post-surgical bowel stasis, and
gastrointestinal motility disorders leading to bowel stasis. Although SIBO is commonly suspected,
a major limitation in the field is the lack of a highly accurate test for SIBO. The current gold
standard relies on the demonstration of an early rise in breath hydrogen concentration in response
to an orally ingested carbohydrate (commonly, lactulose) but its accuracy is about 50%. This may
be because it is a one-time snapshot with an artificial substrate. Further, it has to be performed in
a clinic, takes up to 5 hours and is relatively expensive.  The purpose of this study is to evaluate
the clinical utility of a portable medical device called AIRE, which is a validated and commercially
available handheld breathalyzer that measures hydrogen and methane content in the breath and
connects via Bluetooth to an associated smartphone application to provide immediate results and

Date: May 31, 2022 
Principal Investigator: Glenn Treisman, MD 
Application Number: IRB00204104 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
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visual feedback after use. H2 concentrations determined by the AIRE device showed significant 
correlation with those measured by LHBT. The AIRE device therefore provides an alternative way 
to measure exhaled H2 and methane that have the potential for addressing many of the limitations 
of the standard breath test.  
Study Procedures 
This pilot study will be an open-label trial in patients suspected to have SIBO (abdominal bloating, 
distention, discomfort, change in bowel movements) and who are being considered for diagnostic testing 
using the lactulose-hydrogen breath test (LHBT).  150 patients will be accrued from the gastroenterology 
motility clinic or the scleroderma clinic, in addition, 20 healthy volunteers will be accrued making a grand 
total of 120 participants. Healthy volunteers will be recruited initially at the Ross Research Building. Other 
alternatives provided by The Recruitment Innovation Unit (RIU) from the Institute for Clinical & 
Translational Research (ICTR) Johns Hopkins Medicine may be considered to make our study more 
visible within Hopkins community.  If the subject meets eligibility criteria, and the LHBT has been 
scheduled, a co-investigator will contact the patient to schedule a study visit with a research coordinator 
and obtain a written consent. Potential subjects will be provided with a copy of the Informed Consent form 
prior to the remote consent meeting either via email, fax, mail or previously provided during an in person visit. 
Potential subjects will then be contacted by phone by a study team member who is a consent designee to 
review the consent form in detail. Potential subjects will be given adequate time to consider the research study 
and ask questions prior to signing the consent form. The potential subject will then sign and date/time the 
informed consent document and it will be mailed, emailed or faxed to the consent designee, who will also 
sign/date/time.  A copy of the fully signed consent form will be returned to the volunteer.  The contact and 
screening information of patients that are successfully recruited will be documented, placed in the 
participant’s study folder and stored in a locked cabinet in the motility clinic at Bayview. Any information 
documented during the screening process for patients who do not meet basic eligibility criteria or do not 
wish to participate will be immediately destroyed.  
The study coordinator will maintain a list of all participants, each having a unique participant code, e.g. JH-
SIBO1-001, along with various personally identifiable information, e.g. email, name etc. The coordinator 
will instruct the participant to use the participant code to sign up for the app from FoodMarble. FoodMarble 
however, we would never receive participant’s email address or any information (the participant code is all 
they would have on their servers to identify the participant). 
Enrolled patients will be provided the AIRE device and will be instructed on how to use the device as well 
as the accompanying phone application. Participants will eat their normal, typical diets during the first 
week of the study.  They will use the AIRE machine to measure exhaled H2 and Methane content before 
and after two meals each day – the first meal of the day and the last meal of the day. They will breathe 
into the AIRE machine before eating to obtain a baseline value. Once they have finished eating, they will 
breathe into the AIRE machine 30 minutes, 60 minutes, and 90 minutes postprandially. The exhaled H2 
and Methane results will be automatically recorded in the phone application, which is connected to the 
AIRE machine via Bluetooth. The participants will record their food intake and symptoms directly into their 
smartphone via an app that comes with the AIRE device. Symptom scores will be recorded at the same 
time they use the AIRE machine (30 minutes, 60 minutes, and 90 minutes postprandially). Note 
participants will be asked to not use the AIRE device after a meal including alcohol as this will skew the 
device results, however patients will be asked to record all meal content (including meals with alcohol) in 
their food log throughout the duration of the study.  
Symptomatic participants will be asked to complete the Gastrointestinal Symptom Rating Scale for Irritable 
Bowel Syndrome (GSRS-IBS). The GSRS IBS is a 13-item reliable, valid and user-friendly instrument with 
excellent psychometric properties measuring. Depicting problems with satiety, abdominal pain, diarrhea, 

JHMIRB eFormA  01 
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Date: May 31, 2022 
Principal Investigator: Glenn Treisman, MD 
Application Number: IRB00204104 
constipation and bloating. The internal consistency reliability was high, ranging from 0.74 (pain) to 0.85 
(satiety). Takes approximately 3-5 minutes. Recall period is past week 
Each item is rated on a 7-point Likert scale.  
Healthy volunteers will be asked the Gastrointestinal Symptom Rating Scale (GSRS). This instrument 
address 15 items combined into five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhea and 
Constipation. The reliability and validity of the GSRS are well-documented, and norm values for a general 
population are available. The original questionnaire is an interview-based rating scale but has been 
modified to become a self-administered questionnaire. Takes approximately 3-5 minutes 
Recall period is past week. Each item is rated on a 7-point Likert scale. 
Following a week of AIRE measurement, participants will then undergo the physician-ordered and 
clinically indicated LHBT done on the clinically scheduled day and time.   They will use the AIRE device 
one time immediately before the LHBT begins and throughout the lactulose breath test as well, at the 
same intervals as the lactulose breath test (breathe into AIRE device immediately after breathing into the 
standard lactulose breath test tube).   
Subjects will be notified of the breath test result and whether or not they will receive antibiotics. This will be 
the only result for disclosure to the participant. Decisions regarding treatment will be based on clinical 
judgment and standard of care, after taking into consideration the patient’s history and test results. This 
decision will be made by the care provider (MD or mid-level) and will be discussed with the patient by a 
member of the study team. 
A Lactulose challenge using the AIRE device will be repeated after 5 – 7 days of the initial LHBT if this 
reports negative findings for SIBO. We are testing the hypothesis that repeating the test will increase the 
probability of a positive response. 
If subjects receive antibiotic treatment, they will be asked to use the AIRE device three days before they 
begin taking antibiotics, during treatment, and for four weeks after treatment ends. 
One month later (if no antibiotics were prescribed) participants will repeat the 1-week use of AIRE device 
described above. Therefore, all participants will complete this second week of AIRE use regardless 
whether or not they received antibiotics. A second round of antibiotics will be prescribed if the patient does 
not response to the initial treatment based on the attending physician decision. 
Once the second week of AIRE use is completed, participants will return the AIRE machine. Data from the 
app is automatically downloaded from the app to the Food Marble server. 
Data analysis will be performed at Mayo Clinic Scottsdale, Arizona by Dr. Jay Pasricha,  
(Pasricha.Jay@mayo.edu). This site will no recruit participants.   
Johns Hopkins will serve as coordinating center under supervision of Dr. Glenn Treisman, responsible for 
overall data management, monitoring and communication, and general oversight of the conduct of this 
protocol. 
b.
Study duration and number of study visits required of research participants.
Study duration is approximately 7 weeks with a total of 2 study visits (one initial study visit to allow for
consent and to provide relevant materials, and one follow up study visit (to return materials and allow for
data collection).
c.
Blinding, including justification for blinding or not blinding the trial, if applicable.
N/A: no blinding indicated.

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Date: May 31, 2022 
Principal Investigator: Glenn Treisman, MD 
Application Number: IRB00204104 
d. 
Justification of why participants will not receive routine care or will have current therapy 
stopped.
N/A: participants are not undergoing treatment related to this study. 
e.
Justification for inclusion of a placebo or non-treatment group.
N/A: this is not a drug study.
f.
Definition of treatment failure or participant removal criteria.
Subjects can voluntarily remove themselves from a part or the entire study at any time. Subjects may
also be removed from the study if:
•
failure to follow instructions
•
study is cancelled
•
there may be other reasons to take a subject out of the study that we do not know at this time
g.
Description of what happens to participants receiving therapy when study ends or if a
participant’s participation in the study ends prematurely. 
N/A; subjects are not undergoing any therapy related to this study. 
4.
Inclusion/Exclusion Criteria
Subjects will be recruited from the Johns Hopkins motility disorder clinic and/or the scleroderma
clinic. Inclusion criteria for this study are as follows:
Inclusion:

Adults (18 years of age or older)

Chronic (>3 months) GI symptoms such as nausea, bloating, distention, altered bowel
movements, weight loss or abdominal pain with no structural cause other than scleroderma

Clinical diagnosis of SIBO by patient’s gastroenterologist with plans to obtain a lactulose
hydrogen breath test

Ability to tolerate oral intake

Ability to undergo the LHBT

Access to a smartphone with Bluetooth capability
Exclusion: 

History of current or recent antibiotic use within the last 30 days

History of inflammatory bowel disease

Currently following a restrictive diet (for example low FODMAP diet)

Unable to tolerate oral intake
Criteria for Healthy Volunteers. 
Inclusion: 

Adults (18 years of age or older)

Ability to tolerate oral intake.

Access to a smartphone with Bluetooth capability

Willingness to use the AIRE device at the first and last meal of the day for 8 weeks.

Willingness to complete the GSRS questionnaire.
Exclusion: 

Date: May 31, 2022 
Principal Investigator: Glenn Treisman, MD 
Application Number: IRB00204104 
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
Patients with past or current medical history of gastrointestinal illnesses (Functional and motility
disorders)

Patients diagnosed with SIBO.

Patient currently taking antireflux medications (Proton pump inhibitors, H2 antagonist, etc.)

Patients following a restrictive, gluten free or FODMAP diet.

Previous gastro-esophageal surgery including vagotomy, fundoplication, gastric bypass, ulcer surgery.

Prior GI surgery except for uncomplicated appendectomy and laparoscopic cholecystectomy;

Surgery within the past 3 months.

Patients with BMI lower than 18.5 or higher than 29.9

History of current or recent antibiotic use within the last 30 days.
5.
Drugs/ Substances/ Devices—
The device being tested is AIRE breathalyzer which is a validated and commercially available hydrogen
breathalyzer created by FoodMarble (https://foodmarble.com/).
6.
Study Statistics—
This study is powered around the primary objective i.e. to examine the correlation between
postprandial exhaled hydrogen (H2) content as measured over a 1-week period by AIRE on the
patient’s usual diet at home and the results of the standardized lactulose hydrogen breath test
(LHBT) performed in the clinic. We predict a moderate correlation between these two tests and
assuming an alpha-error of 0.050 and a beta error of 0.200, 100 patients will be sufficient for an
expected correlation coefficient of 0.5.
We are requesting this because although the original aim (comparison to a commercial test) has
been almost completed, an initial look at the data also shows that we may be picking up additional
signals from day to day breath testing that could be a biomarker for the response to antibiotics.
This will however require additional patients since only about 30% of patients are responders
(exemplifying the need for more accurate tests for SIBO); we estimate that by doing 70 more
patients we will get about 20 more responders bringing the total number of responders to about
30, which may give us enough power to test this emerging hypothesis. We will do a formal interim
analysis of this about halfway through the additional recruitment target and reassess the need to
continue at that point.
In order to interpret the postprandial breath readings of SIBO patients it can only be done properly
when compared to normative data. We estimate that 20 healthy volunteers with a proportion of
60% women and 80% between 18 and 40 years old will be enough to compare and interpret
postprandial H2 readings.
In addition to the initial 100 patients and 20 healthy volunteers we want to accrued 50 patients to
examine the correlation of pre and postprandial Methane breath using the AIRE device and
compare also with a LHBT.
7.
Risks
a. Medical risks, listing all procedures, their major and minor risks and expected frequency.
There are no risks to using AIRE breathalyzer when used properly. 
b. Steps taken to minimize the risks.

Date: May 31, 2022 
Principal Investigator: Glenn Treisman, MD 
Application Number: IRB00204104 
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Version 3 Dated:   06/2007 
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N/A 
c.
Plan for reporting unanticipated problems or study deviations.
All adverse events or study deviations will be immediately reported to the IRB. 
d. Legal risks such as the risks that would be associated with breach of confidentiality.
There are minimal risks as all patient information related to the study data will be de-identified. 
e. Financial risks to the participants.
There are no financial risks to the participants. 
8.
Benefits
a.
Description of the probable benefits for the participant and for society.
Participants may benefit from the study by gaining a more thorough understanding of their food
tolerances and intolerances through use of the AIRE device. Society may benefit from the study
through demonstration of clinical efficacy of a convenient and cost-effective device that has the
potential to improve the quality of life for GI patients and reduce cost burden of traditional
investigations and pharmacologic interventions for SIBO.
9.
Payment and Remuneration
a.
Detail compensation for participants including possible total compensation, proposed bonus,
and any proposed reductions or penalties for not completing the protocol.
A $100.00 compensation gift card will be provided for Healthy Volunteers. 
10.
Costs
a.
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify who
will pay for them.
The AIRE devices will be provided by FoodMarble at no cost. The remaining costs for symptom 
questionnaires/food logs are estimated to be minimal and will be accommodated by the study team. 

Do not use this form for consenting research
participants unless the Johns Hopkins Medicine
Logo appears here.
Date: May 31, 2022
Principal Investigator: Pankaj Jay Pasricha MD. 
Application No.: IRB00204104
Page 1 of 7
Combined Parental Permission/Informed Consent/Authorization December 2018 Version 16
RESEARCH PARTICIPANT INFORMED CONSENT AND PRIVACY 
AUTHORIZATION FORM
Protocol Title: 
Clinical utility of handheld hydrogen breathalyzer in identification of 
non-immune mediated food sensitivities (AIRE study)
Application No.:   
IRB00204104
Supporter:
FoodMarble
Principal Investigator: Pankaj (Jay) Pasricha, M.D.
720 Rutland Avenue
Ross Research Building, Room 958
Baltimore, MD 21205
Phone: 410-550-6766
Fax: 410-550-3058
Email: ppasric1@jhmi.edu
You are being asked to join a research study. Participation in this study is voluntary. Even if you decide 
to join now, you can change your mind later.
1.
Research Summary (Key Information):
The information in this section is intended to be an introduction to the study only.  Complete details of
the study are listed in the sections below. If you are considering participation in the study, the entire
document should be discussed with you before you make your final decision.  You can ask questions
about the study now and at any time in the future.
The purpose of this study is to evaluate the clinical utility of a portable medical device called AIRE, an
over-the-counter, commercially available handheld breath analyzer that measures exhaled hydrogen and
methane content. By taking part in this study, you will help to determine whether the device may be
useful to diagnose a condition called Small Bowel Bacterial Overgrowth (SIBO). Although SIBO is
commonly suspected, a major limitation in the field is the lack of a highly accurate test. Thirty people
will be recruited from the gastroenterology motility clinic or the scleroderma clinic. Study duration is
about 7 weeks with two study visits: one initial study visit to allow for consent and to provide the AIRE
device and instructions for using the smartphone app, and one follow up study visit to return the device
and allow for data collection. After the first visit, you will be asked to breathe into the AIRE device once
before and once after your first and last meals of the day for one week. You will also be asked to log
your daily food intake during that week. Then, you will undergo your scheduled standard of care breath
If appropriate for this study, a scanned copy of 
the signed consent form should be uploaded to 
the participant’s Epic/EMR record.
Patient I.D. plate
Approved May 31, 2022

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Date: May 31, 2022
Principal Investigator: Pankaj Jay Pasricha MD. 
Application No.: IRB00204104
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Combined Parental Permission/Informed Consent/Authorization December 2018 Version 16
test while also using the AIRE device. Depending on the results of your standard of care test and the 
decision of your treating physician, you may receive antibiotics. If you do not receive antibiotics, you 
will be asked to complete another week of using the AIRE device and food log one month later. If you 
do receive antibiotics, you will be asked to complete another week of using the AIRE device and food 
log 2 weeks later.
There are no physical risks from using the AIRE device, and the main risk of participation is information 
about you may become known to people outside of this study. There is no benefit to you from being in 
this study.
2.
Why is this research being done?
This research is being done to evaluate the clinical utility of a portable medical device called AIRE, a
handheld breath analyzer that measures the amount of exhaled hydrogen and methane in your breath.
This device connects via Bluetooth to an associated smartphone application called “FoodMarble” to
provide immediate results and visual feedback after use. This evaluation might help to diagnose a
condition called Small Intestinal Bacterial Overgrowth (SIBO), which is a serious condition affecting
the small intestine. It occurs when bacteria that normally grow in other parts of the gut start growing in
the small intestine and causes pain and diarrhea..
The current gold standard is the Lactulose Hydrogen Breath Test – LHBT. The AIRE device is being
compared to the current standard breath test (LHBT) as an alternative way to measure exhaled Hydrogen
and Methane.
Are there any investigational drugs/devices/procedures?
The AIRE device is an over-the-counter commercially available breath analyzer.
Who can join this study?
People 18 years of age or older with a clinical diagnosis of SIBO and scheduled to undergo a lactulose
hydrogen breath test may join this study.
150 participants will be accrued in this study.
20 healthy volunteers will be accrued.
3.
What will happen if you join this study?
If you agree to be in this study, we will ask you to do the following things:
Visit 1:
The AIRE device will be provided to you. You will be instructed on how to use the device and the
accompanying phone application.
For the first week after your visit, we will ask you to eat your normal, typical diet. You will use the
AIRE machine to measure exhaled Hydrogen and Methane content before and after two meals each day
– the first meal of the day and the last meal of the day. You will be asked to breathe into the AIRE
machine before eating to obtain a baseline value. Then you will be asked to breathe into the AIRE
machine 30 minutes, 60 minutes, and 90 minutes after eating. The exhaled hydrogen and methane results
will be automatically recorded in the phone application.
Approved May 31, 2022

Do not use this form for consenting research
participants unless the Johns Hopkins Medicine
Logo appears here.
Date: May 31, 2022
Principal Investigator: Pankaj Jay Pasricha MD. 
Application No.: IRB00204104
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Combined Parental Permission/Informed Consent/Authorization December 2018 Version 16
Every week you will be asked to complete the Gastrointestinal Symptom Rating Scale in Irritable Bowel 
Syndrome (GSRS-IBS). This is a week recall questionnaire with 13 items to assess the severity of your 
gastrointestinal symptoms. 
If you are a healthy volunteer, you will be asked to complete the Gastrointestinal Symptom Rating Scale 
(GSRS) weekly.
You will be asked to record your food intake and symptoms directly into the same smartphone app. 
Please DO NOT use the AIRE device after a meal including alcohol as this will skew the device results, 
however record all meal content (including meals with alcohol) into your food log during the study.
After a week of using the AIRE device, you will undergo your clinically scheduled LHBT (only the 
results of the clinical LHBT test will be disclosed to you). You will be asked to use the AIRE device one 
time immediately before the LHBT begins and throughout the lactulose breath test as well, at the same 
intervals as the lactulose breath test (breathe into AIRE device immediately after breathing into the 
standard LHBT tube). If the AIRE device report is negative, you will be asked to repeat the test using 
only the device to confirm the result.
You will be notified of the standard of care breath test result. Decisions regarding treatment, including 
receiving antibiotics, will be based on the LHBT standard test, clinical judgment and standard of care, 
after taking into consideration your history and test results. This decision will be made by your care 
provider and will be discussed with you. 
If you receive antibiotic treatment, you will be asked to use the AIRE device three days before you 
begin taking antibiotics, during treatment, and for four weeks after treatment ends.
One month later (if no antibiotics were prescribed), you will be asked to repeat the 1-week use of AIRE 
device as described above. All participants will complete this second week of AIRE use the same 
regardless of antibiotic use. 
Visit 2
Once the second week of AIRE use is completed, you will return the AIRE machine for at most a 30 
minute visit. Data from the app is automatically downloaded from the app to the Food Marble server.
Will research test results be shared with you?
It is uncertain if the research tests will produce results that would be relevant for your clinical care, so 
we will not share these results with you.
How long will you be in the study?
You will be in this study for approximately 7 weeks with a total of 2 study visits, each less than 30 
minutes.
4.
What happens to data that are collected in the study?
Johns Hopkins and our research partners work to advance science and public health.  The data we collect
about you are important to this effort.
If you join this study, you should understand that you will not own your research data. If researchers use
your data to create a new product or idea, including those that may have commercial value, you will not
benefit financially from those efforts.
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Combined Parental Permission/Informed Consent/Authorization December 2018 Version 16
How will your data be shared now and in the future? 
Sharing data is part of research and may increase what we can learn from each study. 
Often, data sharing is required as a condition of funding or for publishing study results.  It also is needed 
to allow other researchers to validate study findings and to come up with new ideas. 
Your data may be shared: 

directly with research collaborators, other researchers, sponsors, government agencies,
publishers of papers and other research partners

through government or other databases/repositories
Data sharing could change over time, and may continue after the study ends.
We will do our best to protect and maintain your data in a safe way.  Generally, if we share your data 
without identifiers (such as your name, address, date of birth) no further review and approval by an 
Institutional Review Board (IRB) is needed.  If data are shared with identifiers, further IRB review and 
approval may be needed. The IRB will determine whether additional consent is required.
If you are not comfortable with the use of your data in future research, you may not want to participate 
in this study.
5.
What are the risks or discomforts of the study?
There are no physical risks to using AIRE breathalyzer.
Interviews or questionnaires
You may get tired or bored when we are asking you questions or you are completing questionnaires.
You do not have to answer any question you do not want to answer.
Identifiable private information
There is the risk that information about you may become known to people outside this study.
6.
Are there benefits to being in the study?
There is no benefit to you from being in the study because the results of this study will not be used in
decisions about your treatment. If you take part in this study, you may help others in the future.
7.
What are your options if you do not want to be in the study?
You do not have to join this study. Other options include performing the LHBT only as indicated by
your care provider or receiving a trial of antibiotic for clinically suspicious SIBO.
If you do not join, your care at Johns Hopkins will not be affected.
8.
Will it cost you anything to be in this study?
You will receive a separate Insurance and Research Participant Financial Responsibility Information
Sheet (Sheet). This Sheet will give you the following information:

The procedures, tests, drugs or devices that are part of this research and that will be paid for by
the study (no cost to you).

The procedures, tests, drugs or devices that will be billed to you and/or your health insurer.  If
you have health insurance, you will be responsible for any co-pays or deductibles not covered by
your insurance.
Approved May 31, 2022

Do not use this form for consenting research
participants unless the Johns Hopkins Medicine
Logo appears here.
Date: May 31, 2022
Principal Investigator: Pankaj Jay Pasricha MD. 
Application No.: IRB00204104
Page 5 of 7
Combined Parental Permission/Informed Consent/Authorization December 2018 Version 16
9.
Will you be paid if you join this study?
Healthy volunteers will be compensated for time with a $100.00 gift card.
10.
Can you leave the study early?

You can agree to be in the study now and change your mind later.

If you wish to stop, please tell us right away.

Leaving this study early will not stop you from getting regular medical care.
If you leave the study early, Johns Hopkins may use or share your health information that it has already 
collected if the information is needed for this study or any follow-up activities. 
11.
Why might we take you out of the study early?
You may be taken out of the study if:

Staying in the study would be harmful.

You need treatment not allowed in the study.

You fail to follow instructions.

The study is cancelled.

There may be other reasons to take you out of the study that we do not know at this time.
If you are taken out of the study early, Johns Hopkins may use or give out your health information that it 
has already collected if the information is needed for this study or any follow-up activities.
12.
How will your privacy be maintained and how will the confidentiality of your data
be protected?
HIPAA Authorization for Disclosure of Protected Health Information
What information is being collected, used, or shared?
To do this research, we will need to collect, use, and share your private health information.  By signing
this document, you agree that your health care providers (including both Johns Hopkins Medicine and
others) may release your private health information to us, and that we may use any and all of your
information that the study team believes it needs to conduct the study.  Your private information may
include things learned from the procedures described in this consent form, as well as information from
your medical record (which may include information such as HIV status, drug, alcohol or STD
treatment, genetic test results, or mental health treatment).
Who will see, use or share the information?
The people who may request, receive, or use your private health information include the researchers and
their staff who may be a part of Johns Hopkins Health System, Johns Hopkins University or the Johns
Hopkins Applied Physics Laboratory.  Additionally, we may share your information with other people at
Johns Hopkins, for example if needed for your clinical care or study oversight.  To improve coordination
of your research and clinical care, some information about the study you join will be included in your
electronic medical record.
By signing this form, you give permission to the research team to share your information with others
outside of Johns Hopkins.  This may include the sponsor of the study and its agents or contractors,
outside providers, study safety monitors, government agencies, other sites in the study, data managers
and other agents and contractors used by the study team.
Approved May 31, 2022

Do not use this form for consenting research
participants unless the Johns Hopkins Medicine
Logo appears here.
Date: May 31, 2022
Principal Investigator: Pankaj Jay Pasricha MD. 
Application No.: IRB00204104
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Combined Parental Permission/Informed Consent/Authorization December 2018 Version 16
We try to make sure that everyone who sees your information keeps it confidential, but we cannot 
guarantee that your information will not be shared with others.  If your information is disclosed by your 
health care providers or the research team to others, federal and state confidentiality laws may no longer 
protect it.  
Do you have to sign this Authorization?
You do not have to sign this Authorization, but if you do not, you may not join the study.
How long will your information be used or shared? 
Your Authorization for the collection, use, and sharing of your information does not expire. 
Additionally, you agree that your information may be used for similar or related future research studies.
What if you change your mind?
You may change your mind and cancel this Authorization at any time.  If you cancel, you must contact 
the Principal Investigator in writing to let them know by using the contact information provided in this 
consent form.  Your cancellation will not affect information already collected in the study, or information 
that has already been shared with others before you cancelled your authorization.
How will your information be protected?
The study coordinator will maintain a list of all participants, each having a unique participant code, along 
with personally identifiable information, such as your email, name etc. Your de-identified information 
will be stored in a locked cabinet in the motility clinic at Bayview. 
The coordinator will give you instructions about using your participant code to sign up for the app from 
FoodMarble. FoodMarble would never receive your email address or any information (the participant 
code is the only way to identify you).
13.
Will the study require any of your other health care providers to share your health
information with the researchers of this study?
As a part of this study, the researchers may ask to see your health care records from your other health
care providers.
14.
What other things should you know about this research study?
During the study, we will tell you if we learn any new information that might affect whether you wish to
continue to participate.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S.
Law.  This Web site will not include information that can identify you. At most, the Web site will
include a summary of the results. You can search this Web site at any time. If you would like to review
the information for this study, or a summary of the results, ask the study team doctor for the
ClinicalTrials.gov study registration number.
What is the Institutional Review Board (IRB) and how does it protect you?
This study has been reviewed by an Institutional Review Board (IRB), a group of people that reviews
human research studies. The IRB can help you if you have questions about your rights as a research
participant or if you have other questions, concerns or complaints about this research study.  You may
contact the IRB at 410-502-2092 or jhmeirb@jhmi.edu.
Approved May 31, 2022

Do not use this form for consenting research
participants unless the Johns Hopkins Medicine
Logo appears here.
Date: May 31, 2022
Principal Investigator: Pankaj Jay Pasricha MD. 
Application No.: IRB00204104
Page 7 of 7
Combined Parental Permission/Informed Consent/Authorization December 2018 Version 16
What should you do if you have questions about the study, or are injured or ill as a result of being 
in this study? 
Call the principal investigator, Dr. Pankaj Pasricha at 410-550-6766. If you wish, you may contact the 
principal investigator by letter. The address is on page one of this consent form. If you cannot reach the 
principal investigator or wish to talk to someone else, call the IRB office at 410-502-2092.  
15.
What does your signature on this consent form mean?
Your signature on this form means that you have reviewed the information in this form, you have had a
chance to ask questions, and you agree to join the study. You will not give up any legal rights by signing
this consent form.
WE WILL GIVE YOU A COPY OF THIS SIGNED AND DATED CONSENT FORM
________________________________________________________________________________________________________________________
Signature of Participant 
(Print Name) 
Date/Time 
________________________________________________________________________________________________________________________
Signature of Person Obtaining Consent 
(Print Name) 
Date/Time
I have received the separate Insurance and Research Participant Financial Responsibility Information Sheet.  
________________________________________________________________________________________________________________________
Signature of Participant, LAR or Parent/Guardian 
(Print Name)
Date/Time
NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL INVESTIGATOR AND A COPY 
MUST BE GIVEN TO THE PARTICIPANT.  IF APPROPRIATE FOR THIS STUDY, A SCANNED COPY OF THE SIGNED CONSENT 
FORM SHOULD BE UPLOADED TO THE PARTICIPANT’S EPIC/EMR RECORD (UNLESS NO MEDICAL RECORD EXISTS OR 
WILL BE CREATED). 
Approved May 31, 2022