Project V - A Randomized Controlled Prospective Study of the Next-generation Probiotic, Veillonella Atypica FB0054, vs Placebo in Healthy Adults
Conditions: Fatigue
Sponsor: FitBiomics, Inc.

Project V – A randomized controlled prospective study of the next-generation probiotic, Veillonella
atypica FB0054, vs placebo in healthy adults
Version Date:
May 16, 2023
Protocol Version:
Protocol Number:
01
FB004
Sponsor:
FitBiomics, Inc.
180 Varick St
6th Floor
New York, NY 10014
Principal Investigator:
Jonathan Scheiman
FitBiomics, Inc
180 Varick St
6th Floor
Jonathan.scheiman@fitbiomics.com
Participating Sites:
FitBiomics, Single Site Study

Table of Contents
Table of Contents
2
Table of Acronyms
4
Title
4
Principal Investigator
4
Study Synopsis
4
Background and Rationale
4
Objectives
5
Study Supplement
5
Subject Selection
5
Inclusion Criteria
5
Exclusion Criteria
5
Research equity
6
Vulnerable Populations
6
Study Procedures
6
Recruitment
6
Details Study Procedures
6
Figure 1. Study Procedures
7
Table 1. Survey Details
7
Table 2. Survey Schedule
8
Completing Research Activities
8
Compensation
8
Research results or clinical findings arising from research activities
8
Risk/Safety Information
9
For Veillonella:
9
For Placebo:
9
Other risks of study procedures
9
Unforeseen Risks
9
Risk Level Determination
9
Alternatives to Participation
9
Participant Withdrawal from Research/ Research Activities
9
Monitoring / Reporting of AE/SAE
10
Study Oversight
10
1

Ethical and Regulatory Standard
10
IRB Review / Ethics / Informed Consent
11
Study Compliance and Reporting Deviations
11
Conditions for Study Termination or Suspension
12
Informed Consent
12
Privacy Authorization
12
State of California Human Experimentation Requirements
13
Data Management
13
Confidentiality
13
Return or Clinical Use of Research Results
13
Intended Use of the Data
14
Information/Data Retention, Future Use, and Sharing
14
Publication
14
Biostatistical Analysis Plan
14
Data Source
14
Analysis Objectives
14
Analysis Sets / Populations / Subgroups
14
Endpoints
15
Handling of Missing Values
15
Statistical Procedures
15
Measures to Adjust for Confounders
16
QC Plans
16
Programming Plans
16
Investigator Conflict of Interest
16
References
17
2

Table of Acronyms
(in alphabetical order)
Acronym
Definition
AE
Adverse Event
BMI
Body Mass Index
CFR
Code of Federal Regulations
Chloe
Consumer Health Learning and Organizing Ecosystem
FDA
Food and Drug Administration
GCP
Good Clinical Practice
GSE
General Self Efficacy (a questionnaire)
HIPAA
Health Insurance Portability and Accountability Act
ICH
International Council for Harmonization
IRB
Institutional Review Board
I/E
Inclusion / Exclusion (criteria)
MFI
Multi-dimensional Fatigue Inventory (a questionnaire)
NIH
National Institute of Health
PI
Principal Investigator
QC
Quality Control
SAE
Serious Adverse Event
US
United States
3

Study Synopsis
In this study, we are assessing the ability of Veillonella (Veillonella atypica FB0054) to decrease fatigue
and increase energy in a heterogeneous cohort of healthy adults compared to placebo. Study subjects
will fill out a baseline health and habit survey followed by daily and weekly surveys over a two week
baseline period to understand their baseline habits, fatigue, and energy levels. After this, subjects will
take one daily capsule orally of one of two doses of Veillonella or placebo for four weeks, while again
filling out both daily and weekly surveys. Finally, there will be a two week washout period with no
supplementation but only daily and weekly surveys. At the end of the study, there will be a final
experience survey.
Background and Rationale
Veillonella is a novel probiotic that can metabolize lactic acid into propionate, which is an energy source
for the body [1, 2]. In previous research, we have shown that Veillonella can improve endurance
compared to placebo. In mouse studies, those mice who supplemented with V. atypica ran 13% longer in
a run-to-exhaustion test than those mice who were given placebo [1]. Furthermore, in a randomized
controlled crossover pilot study, we could show that Veillonella prevented 78.7% of the performance
decline observed in the placebo group in a run-to-exhaustion model [3]. We have also conducted
experiments that have resulted in this product being deemed Generally Regarded As Safe (GRAS) [4].
Therefore, we believe the Veillonella is safe and likely to provide significant benefits in terms of improved
endurance, increased energy, and decreased fatigue. This research study is designed to test that
hypothesis. FitBiomics is sponsoring this study to confirm these effects in a broader population.
FitBiomics is the first company to develop this type of bacteria as a probiotic, and this will be the largest
study testing the safety and efficacy of this probiotic.
Objectives
The purpose of this research study is to:
●
Test the safety and effectiveness of the study drug, Veillonella (Veillonella atypica FB0054), a
next-generation probiotic strain.
●
Identify the types of benefits observed in a broad population
Study Supplement
The study supplement here includes one of two doses of Veillonella or placebo. Veillonella contains
Veillonella atypica FB0054 as the active ingredient with microcrystalline cellulose and hypromellose as
excipients. The two doses are 15 billion cfu (high dose) and 7.5 billion cfu (low dose). Placebo capsules
contain microcrystalline cellulose and hypromellose. Both Veillonella and placebo are encapsulated in
acid-resistant capsules to improve delivery to the large intestine, which participants will take orally at
home on a daily basis for four weeks.
4

Subject Selection
Participants in this study will be healthy adults interested in using Veillonella to reduce fatigue and
increase energy. Subjects will be excluded from the study if they have conditions, diseases, or
medications that could result in increased likelihood of AEs related to Veillonella use.
Inclusion Criteria
●
Male or female adults aged 18 – 65 years.
●
Willing and able to provide written informed consent.
●
Ability of the participant to comprehend the full nature and purpose of the study including
possible risks and side effects.
●
Agreement to comply with the protocol and study restrictions.
●
Fluent in written and spoken English.
●
In good general health as judged by the Investigator based on medical history.
●
Willing to maintain daily exercise and diet habits throughout the 8 week study without making
major lifestyle changes.
●
Ability to use a personal smartphone device and download the Chloe app by People Science
Exclusion Criteria
●
Currently pregnant, planning to become pregnant, or lactating during the next 12 weeks
●
Have a significant acute or chronic coexisting illness, disorder, or condition that contraindicates,
in the Principal Investigator's judgment, entry to the study.
●
Currently taking immunosuppressive medications.
●
Is considered immunosuppressed for any reason.
●
Currently taking medications that could impair the integrity of the gut epithelia
●
Has symptoms or an illness, disorder, or cognition that impairs the integrity of the gut epithelia.
●
Current antibiotic use or planned oral antibiotic use over the course of the study.
●
Investigator believes that the participant may be uncooperative and/or noncompliant and should
therefore not participate in the study.
Research equity
This research has no direct exclusions related to gender. There are also no direct exclusions related to
race or ethnicity.
Vulnerable Populations
Vulnerable populations are not specifically targeted in this research. Racial and ethnic minorities will be
included in the participants but are not specifically targeted for inclusion.
Study Procedures
See Figure 1 for details of study procedures.
Recruitment
Participants will be recruited to the study via email and social media. Interested participants will sign up
though the online study landing page. Participants will be chosen from the pool of signups based on the
5

inclusion and exclusion criteria above. There is no maximum number of participants. All those eligible
will be invited to participate. However, we estimate up to 1,000 participants will be invited to participate
in the study.
Details Study Procedures
Once participants are invited to the study, they will be sent an email with a link to the Chloe application,
which they will download to their mobile device. Chloe will lead them through a detailed description of
the study and the informed consent process. At this point, they will also consent to sharing their fitness
tracker data, as an option, if they have one. The fitness tracker data will be used to answer sleep
questions and other fitness tracker data will be stored for analysis by the FitBiomics team. Once
informed consent is obtained, participants will fill out a baseline health and lifestyle survey, where they
will also share their mailing address. Once this survey is completed, the participant will be randomized to
a high dose Veillonella (15 billion cfu), low dose Veillonella (7.5 billion cfu), or placebo in a 4:4:2 ratio
respectively. These capsules will be mailed to the participant during the 2 week baseline period.
Completion of the initial baseline health and habit survey initiates the 2 week baseline period. During
this period, participants will fill out daily surveys on sleep, energy, and bowel movements and weekly
surveys on other benefits and adverse events (AEs) they have noticed (more details on all surveys can be
found in Tables 1 and 2). On the final day of the two week baseline, they will also fill out the
Multidimensional Fatigue Inventory (MFI) and General Self-Efficacy (GSE) questionnaires. At this point,
participants will begin supplementation. Participants will supplement with one capsule daily for 4 weeks.
During the supplementation phase, participants will fill out the same daily and weekly surveys. On the
final day of the supplementation period, participants will also fill out the Multidimensional Fatigue
Inventory and General Self-Efficacy questionnaires. After supplementation, there will be a two week
washout period to monitor patients and to understand the lasting effect of any benefits they
experienced. During the washout period, participants will again fill out the same daily and weekly
surveys. On the final day of the washout period, there will be two additional surveys: one with some
additional questions on changes observed throughout the study and one of open ended questions on
the whole study experience.
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Figure 1. Study Procedures
Table 1. Survey Details
Survey Name
Survey Details
Number of
Questions
Estimated Time
to complete
Number of
Times Used
Total survey
time
Study sign up
form
Form used to express interest in the
study, includes questions on
participant demographics and to
include / exclude participants
18
5 minutes
1X
5 minutes
Baseline survey
Includes questions on daily habits and
lifestyle as well as baseline questions
on normal fatigue and energy levels
31
10 minutes
1X
10 minutes
Daily survey
Daily assessment of the participant’s
sleep, energy, and bowel movements
4
< 1 minute
56X
56 minutes
Weekly Survey
Participants are asked to look back at
their week and report their feelings of
fatigue, energy, mood, and health, as
well as their exercise and other
physical activity
18
5 minutes
8X
40 minutes
7

MFI
A self-report instrument designed to
measure fatigue. It covers the
following dimensions: General Fatigue,
Physical Fatigue, Mental Fatigue,
Reduced Motivation and Reduced
Activity.
20
5 minutes
2X
10 minutes
GSE
PROMIS self-efficacy survey designed
to be non-disease specific measure of
life management and physical
functioning
4
< 1 minute
2
2 minutes
End of study
survey
A repetition of some questions from
the baseline survey to assess whether
there have been significant changes
over the course of the study
4
< 1 minute
1
1 minute
Experience survey
Mostly open ended questions on
experience in the study itself, including
questions designed to inform future
marketing of Veillonella
6
5 minutes
1
5 minutes
Total survey time
139 minutes
Table 2. Survey Schedule
Recruitment
Pre-Week 1
Week 1
Week 2
Week 3
Week 4
Week 5
Week 6
Week 7
Week 8
Study sign
up form
1X
Informed
consent
1X
Baseline
survey
1X
Daily survey
Daily
(7X)
Daily
(7X)
Daily
(7X)
Daily
(7X)
Daily
(7X)
Daily
(7X)
Daily
(7X)
Daily
(7X)
Weekly
survey
1X at
end of
week
1X at
end of
week
1X at
end of
week
1X at
end of
week
1X at
end of
week
1X at
end of
week
1X at
end of
week
1X at
end of
week
MFI
1X at
end of
week
1X at
end of
week
GSE
1X at
end of
week
1X at
end of
week
End of study
survey
1X at
end of
week
8

Experience
survey
1X at
end of
week
Completing Research Activities
Compensation
Participants will receive points in the Chloe mobile app to be used toward an Amazon Gift Card and be
provided with a discount code to purchase the Nella probiotic.
Research results or clinical findings arising from research activities
Due to the nature of the study, it is unlikely that research results or findings from research activities will
result in further medical-related expenses for the participant.
Risk/Safety Information
Starting a new probiotic tends to result in mild and transient gastrointestinal upset. In our previous pilot
human studies, we have observed these symptoms, but they were mild enough to not interfere with a
run-to-exhaustion endpoint. The surveys used in this study include a question on potential symptoms
experienced, which will allow us to identify additional potential AEs as well as known side effects that
persist longer than expected.
For Veillonella:
Very common (greater than or equal to 1/10)
●
Mild gastrointestinal upset including temporary increases in gas, bloating, cramping, and nausea
●
Nervousness and increased feelings of anxiety
For Placebo:
●
None known
Other risks of study procedures
Questionnaires: The questions used in this survey may cause temporary discomfort or distress to the
participant. The survey is designed to be simple and short and is a commonly used tool in clinical
studies. The participant may choose not to complete the questionnaire.
Breach of Confidentiality: There is minimal risk that people who are not connected with this study will
learn of the participant’s identity or personal information. The study staff will be GCP trained and will
utilize best practices when using the data platform to ensure participant privacy protections.
Unforeseen Risks
There may be other risks that are unknown. Additionally, there may be unknown risks to a pregnancy,
embryo, or fetus if you or your female partner become pregnant.
9

Risk Level Determination
The risks to the study are minimal or unanticipated due to appropriate mitigation measures (e.g. breach
of confidentiality, loss of internet access). This research meets the federally defined definition of minimal
risk (45CFR 46.102(j)).
Alternatives to Participation
The individual can choose not to participate.
Participant Withdrawal from Research/ Research Activities
Research activities are limited to five weeks.
Participants may withdraw from the study at any time and for any reason without prejudice. The
withdrawal must be documented.
Monitoring/Reporting of AE/SAE
AEs and SAEs will be detected using the weekly surveys. On a weekly basis, participants are asked if they
have stopped taking the product due to side effects. If they answer in the affirmative, they can provide
more information on the symptoms and their severity. Participants can also report AEs and SAEs to the
study staff at any time via phone or email.
An AE is defined as any reported side effect of the product that is likely due to Veillonella itself. Based on
our previous work, we anticipate mild and transient gastrointestinal upset as well as mild anxiety as
possible common AEs.
An SAE is defined as any severe and/or unexpected side effect that is life threatening, requires medical or
surgical intervention, or is otherwise an important medical event for the patient. SAEs are also AEs that
result in hospitalization, disability or permanent damage, or death. These will be reported to the FDA.
FitBiomics is utilizing a company called SafetyCall for AE monitoring and reporting in this study.
SafetyCall will provide adverse event management, incident documentation, and first aid advice for basic
on-site patient management, general medical and clinical toxicology consultation for health care
providers, and health and safety information to the study participants, customers, medical personnel,
and others. Services are provided by telephone 24 hours a day, 365 days a year.
SafetyCall will also provide adverse event management and incident documentation for non-telephone
based correspondence such as consumer email, customer service notifications, internet-based inquiries
and written communications. These services include an initial professional assessment for health risk
and triage. SafetyCall will respond to any inquiries it receives, including incidents involving either humans
or animals consistent with standard of care practices. A lead toxicologist is available from 9:00am to
5:00pm Central Standard Time, Monday through Friday. An on-call toxicologist is available after hours.
SafetyCall will also manage reporting of AEs to the FDA. In compliance with the Dietary Supplement and
Nonprescription Drug Consumer Protection Act (Pub. L. 109-462, 120 Stat. 3469), any correspondence or
verbal notification of a potential adverse event (AE) in association with a dietary supplement received by
a manufacturer and/or its subsidiaries will be documented according to FDA mandated data collection
guidelines and all records retained for a minimum of 6 years for potential review by the FDA. Those
10

adverse events meeting the FDA defined criteria for serious will be reported to the FDA within 15-
business days using the FDA Form 3500A and its accompanying data elements.
Study Oversight
This study will be made available for monitoring, auditing, IRB review and regulatory inspection by
providing direct access to study related source data.
Ethical and Regulatory Standard
This study will be conducted in conformance with the principles set forth in The Belmont Report: Ethical
Principles and Guidelines for the Protection of Human Subjects of Research (US National Commission for
the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979) and the
Declaration of Helsinki.
This study is to be conducted in compliance with the IRB approved protocol and according to applicable
federal, state, local and tribal laws including the following:
●
US Code of Federal Regulations (CFR) governing clinical study conduct: Title 45 Part 46 –
Protection of Human Subjects
●
US Code of Federal Regulations relating to the Health Insurance Portability and Accountability
Act of 1996: Title 45 Part 164 – Security and Privacy – Subpart E - ○Subpart E—Privacy of
Individually Identifiable Health Information
●
State of California Health and Safety Code, Title 17, for research conducted in California
In addition, this study is to be conducted in compliance with applicable policies and procedures of the
Advarra IRB, applicable institutional research policies and procedures, applicable institutional clinical
policies and procedures, and applicable NIH policies and procedures.
IRB Review / Ethics / Informed Consent
The protocol, informed consent form(s), recruitment materials and all participant materials will be
submitted to the Advarra IRB for review and approval. Approval of both the protocol and the consent
form must be obtained before any participant is enrolled. Any amendments to the protocol or consent
materials will require review and approval by the IRB before the changes are implemented in the study.
Per the federal regulations at 45 CFR 46 and State of California Health and Safety code, Title 17, must
review and approve this protocol and the informed consent process and its documents prior to initiation
of the study. All institutional, NIH, Federal, and State of California regulations must be fulfilled.
Any documents that the IRB may need to fulfill its responsibilities (such as protocol, protocol
amendments, consent forms, information concerning participant recruitment, payment or
compensation procedures, or other pertinent information) will be submitted to the IRB. The IRB’s
written approval of the study protocol and the informed consent document will be in the possession of
the investigator before the study is initiated.
Any amendment to the protocol document and accompanying informed consent documents, as
developed and provided by the PI, will require review and approval by the IRB of record before the
changes are implemented in the study.
11

Study Compliance and Reporting Deviations
A deviation is a divergence from a specific element of a protocol and that occurred without prior IRB
approval. Deviations from the approved protocol will be avoided, except when necessary to eliminate an
immediate hazard to a research participant. All deviations from the protocol will be documented in
study source documents and promptly reported to the IRB.
Investigators may deviate from the protocol to eliminate immediate hazards for the protection, safety,
and well-being of the study subjects without prior IRB approval. For any such deviation, the PI will notify
the IRB, within 5 calendar days of its occurrence by electronic submission of a deviation notice.
Conditions for Study Termination or Suspension
This study will be terminated prematurely in the following situations:
●
There are unforeseen safety issues or if other studies are published that indicate a presence of
unanticipated toxicity risks that cannot be adequately quantified.
●
The protocol is determined to no longer meet study or sponsor objectives.
The study PI or the IRB may terminate or suspend this study at any time. If the study is prematurely
terminated or suspended, participants will be instructed as to whether they should complete
supplementation. Participants will be monitored and continue follow up for 2 weeks after they stop
supplementation to ensure their safety and to collect any final data. All participants who have completed
at least 50% of surveys at the time that the study is terminated or suspended will be provided with a
discount code to purchase the Nella probiotic as compensation.
Informed Consent
Informed consent is a process that is initiated prior to the individual agreeing to participate in the study
and continues throughout study participation. Operational details specific to the consenting process that
occurs prior to any research evaluations/interventions are described in Section 6.0.
All participants will undergo virtual electronic informed consent after they are determined to qualify for
the study. An electronic informed consent document will describe the nature, duration, purpose of the
study, potential risks, alternatives and potential benefits, and all other IRB approved information. In
addition, the experimental participant’s bill of rights and the HIPAA research authorization form will be
provided. Prospective research participants will be informed that they may withdraw from the study at
any time and for any reason without prejudice. Prospective research participants will be afforded
sufficient time to consider whether to participate in the research.
Virtual informed consent will be conducted through the app-based consent form at the participant’s
convenience. After reading the consent, participants will be able to contact study staff about any study
related questions. Once the prospective participant expresses full understanding, virtual informed
consent will be obtained through electronic signature from either the prospective participant before
study participation. The method of obtaining and documenting the informed consent and the contents
of the consent must comply with the ICH-GCP and all applicable regulatory requirements. A copy of the
signed consent document will be available to the participant within the Chloe app. The signed consent
must be maintained by the investigator and available for inspection by sponsor designated
representatives, or regulatory authority at any time.
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Privacy Authorization
The informed consent process will include a privacy authorization compliant with 45CFR164.508(c) via
the inclusion/incorporation of:
-
all core elements specified in 508(c)(1) including the signature of the individual (or
representative) and date of signature,
-
all required statements specified in 508(c)(2)
-
the plain language requirement as specified in 508(c)(3), and
-
the provision to the participant (or representative) a copy of the signed authorization
(508(c)(4)
State of California Human Experimentation Requirements
This research involves the collection of information via validated questionnaires and obtaining
information from the medical record. Research activities do not encompass those that are requisite for a
participant to be involved in a “medical experiment” as defined by California State Law 24174. The
‘California Experimental Subject’s Bill of Rights’ will be administered as part of the informed consent
process; as part of that process participants will receive a copy of the ‘Bill of Rights’ marked with their
signature.
Data Management
Study data will be stored in secure password-protected servers. Study staff will de-identify all data prior
to data analysis. Data will be analyzed to compare the safety and efficacy of Veillonella vs placebo and
between the two different doses of Veillonella. We will also use these data to better understand the type
of benefits different subsets of participants tend to experience as well as the magnitude of the benefit in
these subpopulations. These results will be used to create peer-reviewed publications, academic and
industry presentations, file patents, and potentially develop new innovative microbiome products like
probiotics. Participants will not be notified of any of these uses.
Confidentiality
All documents and electronic data will be stored on secure, password-protected computers. Participant
confidentiality will be strictly held in trust by the investigators, study personnel, and sponsor. No
identifiers will be used in any subsequent publication of these results.
Records of participation in this study will be held confidential except when sharing the information is
required by law or as described in this informed consent. The Investigator, the sponsor or persons
working on behalf of the sponsor, and under certain circumstances, the US FDA and the IRB will be able
to inspect and copy confidential study-related records and identify subjects by name. This means that
absolute confidentiality cannot be guaranteed. This does not limit the duty of the researchers and others
to protect participants’ privacy. Study records including confidential information about study subjects
collected during the study will be kept at a secure location or server. If the results of this study are
published or presented at meetings, participants will not be identified.
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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 participants. At most, the Web site will
include a summary of the results.
Return or Clinical Use of Research Results
Participants will be shown their study data in real time as they go through the data visualization modules
in the Chloe platform.
Research results will be shared with participants at completion of data analysis. The results of this
research may help the participant make decisions in future product purchases and participate in future
research studies.
There are no anticipated burdens or financial obligations to research subjects.
Intended Use of the Data
Information/Data Retention, Future Use, and Sharing
The data collected as part of this study will be used to assess the safety and efficacy of Veillonella in this
population. These data may be used in peer-reviewed manuscripts, research presentations, and other
materials to promote FitBiomics and its platform, or to develop new products. All data will be
deidentified prior to any publication or presentation. Prior to the completion of this research,
information will be coded, destroyed, de-identified, or provided to a privacy officer.
Publication
The publication or presentation of any study results shall comply with all applicable privacy laws,
including, but not limited to, the Health Insurance Portability and Accountability Act of 1996. Neither
the complete nor any part of the results of the study carried out under this protocol, nor any of the
information provided by the sponsor for the purposes of performing the study, will be published or
passed on to any third party without the written approval of the Study PI. Any investigator involved with
this study is obligated to provide the sponsor with all data derived from the study.
Biostatistical Analysis Plan
Data Source
The source of the data is the results of the questionnaires filled out through the Chloe app as well as the
optional fitness tracker data collected over the course of the study.
Analysis Objectives
The goals of this analysis are to identify whether there are statistically significant differences in effects
between the placebo and Veillonella groups as well as between the high and low dose Veillonella groups.
Furthermore, for any differences that are observed, we would like to understand whether there are any
demographic or other participant characteristics that may be associated with benefits or side effects
experienced by the participants.
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Analysis Sets / Populations / Subgroups
The three groups compared in this study are high dose Veillonella, low dose Veillonella, and placebo.
In addition, we plan to separately analyze results by gender, age, baseline exercise habits, health history,
previous probiotic experience, sleep habits, and other lifestyle factors.
For those participants who share fitness tracker data, the fitness tracker data shared through the Chloe
app will be analyzed in conjunction with survey data separately from those who did not share fitness
tracker data.
Endpoints
The primary endpoints analyzed in this study are:
-
Change in reported physical fatigue
-
Change in mental / emotional fatigue
-
Change in MFI
The secondary endpoints analyzed in this study are:
-
Change in reported sleep quality
-
Change in frequency of reported physical activity
-
Change in intensity of reported physical activity
-
Change in reported exercise
-
Change in recovery time
-
Change in energy level
The exploratory endpoints analyzed in this study are:
-
Changes in fitness tracker data
-
Change in reported bowel movements
-
Change in GSE
-
Change in reported mood
-
Change in reported digestive health
-
Change in reported general health
-
Change in BMI, weight, or waist circumference
Handling of Missing Values
There will likely be missing values related to incomplete or missing surveys. Participants will only be
included in the analysis if they completed at least 50% of weekly surveys during each time period:
baseline, supplementation, and washout. Values will be binned longitudinally such that each participant
included in the analysis has a data point associated with each bin. If there are multiple values associated
with a participant in a bin, the mean of those values will be used for the analysis.
Statistical Procedures
The majority of primary and secondary endpoints for this study are questions on the survey which
consist of rating scales (generally 1-5 or 1-9). Significant differences between groups for these endpoints
will be assessed using an independent T test or Mann-Whitney U test depending on the observed
15

distribution of the data. For significant changes over time within the same group, a dependent T test will
be used.
For differences between groups in terms of primary and secondary endpoints that measure a change in
time (e.g. time to recovery in days or hours of sleep), an independent T test or Mann-Whitney U test will
be used, depending on the observed distribution of the data. For significant changes over time within
the same group, a dependent T test will be used.
To identify demographics associated with any particular response (benefit or side effects), we will use
the demographic, health history, and lifestyle information collected in the surveys to build an
unsupervised machine learning algorithm (e.g. Random Forest Classifier). If we can build one that
effectively classifies the response (AUC > 0.7), we will identify the model’s most important features. To
confirm that these features are significantly associated with response, we will use an independent T test
to assess significant differences between response and non-response.
For all other exploratory endpoints including the optional fitness tracker data, the data type and
distribution of that data will determine the statistical analysis used.
Measures to Adjust for Confounders
For all data and endpoints, data can be normalized to the baseline collected values, and change in value
at different time points can be compared using the statistical tests described above.
In addition, there is a question included in the weekly surveys assessing how participants are generally
feeling about their life, which they respond to using a rating scale from 1 (pessimistic) to 9 (optimistic). If
necessary, we can normalize the weekly survey data using this rating to confirm that participant life and
stress outside the study are not affecting how they respond to the surveys.
QC Plans
All analyses will be performed by a study bioinformatician or data scientist. All code used for the analysis
will be saved using version control software such as Git in the format or Python notebooks. These
notebooks will be reviewed by other study staff for errors and certified that analyses are correct prior to
any written or oral reports, presentations, or publications on the results of the study.
Programming Plans
All code for these analyses will be written using Python 3 in Jupyter notebooks. The pandas library will
be used for importing the data, manipulating it in a data frame, and exporting it as excel or
comma-separated files. The Numpy and Scipy libraries will be used for all statistical analysis and the
Sci-Kit Learn library will be used for machine learning analyses. Matplotlib and Seaborn libraries will be
used for visualization of the data as graphs and charts.
Investigator Conflict of Interest
Investigators will disclose any conflict of interest.
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or financial
gain greater than the minimum allowable by their institution, etc.) must have the conflict reviewed by a
properly constituted Conflict of Interest Committee with a Committee-sanctioned conflict management
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plan that has been reviewed and approved by the study Sponsor prior to participation in this study. All
investigators will follow the conflict of interest policy.
References
1. Scheiman J, Luber JM, Chavkin TA, MacDonald T, Tung A, Pham L-D, et al. Meta’omic analysis of elite
athletes identifies a performance-enhancing microbe that functions via lactate metabolism. Nat Med.
2019;25:1104–9.
2. Ng SK, Hamilton IR. Carbon dioxide fixation by Veillonella parvula M 4 and its relation to propionic acid
formation. Can J Microbiol. 1973;19:715–23.
3. Gross K, Santiago M, Krieger JM, Hagele AM, Zielinska K, Scheiman J, et al. Acute Impact of Veillonella
atypica FB0054 Supplementation on Exercise Performance and Lactate Changes: A Randomized,
Crossover Pilot. Nutrients. In Review.
4. Preece KE, Glávits R, Murbach TS, Endres JR, Hirka G, Vértesi A, et al. Safety evaluation of Veillonella
atypica FB0054 with genotoxicity and subchronic toxicological studies. J Appl Toxicol JAT.
2023;43:808–27.
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