Clinical trial NCT04531033: Does Daily Supplementation of Lactobacillus Acidophilus MPH734, for One Week, Affect Acute (Immediate), Subacute (7 Days), and Post-treatment Discontinuation Lactose Metabolism, Gastrointestinal Symptoms, and Clinical Markers of Inflammation and Safety Compared to a Placebo
Official title: Does Daily Supplementation of Lactobacillus Acidophilus MPH734 (Lacto-FreedomTM, or LF), for One Week, Affects Acute (Immediate), Subacute (7 Days), and Post-treatment Discontinuation (30-, 60-, and 90- Day) Lactose Metabolism, Gastrointestinal Symptoms, and Clinical Markers of Inflammation and Safety Compared to a Placebo?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactose Intolerance
Keywords: lactose intolerance
probiotic
Lead sponsor: University of Mary Hardin-Baylor
Sponsor class: OTHER
Collaborators: name: Manzo Pharmaceuticals
First posted: 2020-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 treatments: low dose probiotic, high dose probiotic, placebo
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if twice or three times daily supplementation of Lactobacillus acidophilus MPH734 (Lacto-FreedomTM, or LF), for one week, affects acute (immediate), subacute (7 days), and post-treatment discontinuation (30-, 60-, and 90- day) lactose metabolism, gastrointestinal symptoms, and clinical markers of inflammation and safety compared to a placebo.

Detailed description: Participants will be included and/or excluded in the study based on the criteria below:

Inclusion Criteria

* Participants will be male or female between the ages of 18-55 years;
* Participants will be apparently healthy and free from disease, as determined by a health history questionnaire;
* Participants will not be excluded if he or she has been clinically diagnosed with a carbohydrate malabsorption disorder, or is or has been prescribed to take prescription or over-the-counter medication for such;
* Participant has self-diagnosed or otherwise avoids consuming dairy, lactose, and other dairy-containing products, or regularly consumes Lactase enzymes for digestive support;
* Participant agrees and can comply with the study protocol;
* Participant provides signed and dated informed consent to participate in the study.

Subject Exclusion Criteria

* Participant is or may be pregnant, is trying to become pregnant, or is breastfeeding;
* Participant is insulin-dependent or -independent diabetic.
* Participant currently uses, or has discontinued the use of nicotine-containing products within twelve (12) months of the start of the study;
* Participant lives or works within an environment that chronically exposes the subject to second-hand smoke;
* Participant currently uses, or has discontinued the use of recreational drugs or medicinal marijuana within twelve (12) months of the start of the study;
* Participant has been clinically diagnosed with a digestive disorder such as gastrointestinal disease, chronic diarrhea or constipation, irritable or inflammatory bowel syndrome, Crohn's disease, or is, or has been prescribed to take prescription or over-the-counter medication for such;
* Participant has ever undergone gastric bypass surgery, or has undergone an abdominal or other gastrointestinal surgery within twelve (12) months of the start of the study;
* Participant is taking, or has taken antibiotic medications within two (2) weeks of the start of the study;
* Participant has undergone a colonoscopy within two (2) weeks of the start of the study, or is scheduled to receive a colonoscopy during the study;
* Participant has undergone a barium study or received an enema within two (2) weeks of the start of the study, or is scheduled to, or receives such during the study;
* Participant is taking, or has taken probiotics within two (2) weeks of the start of the study;
* Participant uses lactose digesting enzymes during the study;
* Participant is taking, or has taken weight loss, prebiotic \[e.g., fructo- or galacto-oligosaccharides (FOS or GOS), psyllium, or insulin fiber, etc.\], or laxative / stool softener dietary supplements, over-the-counter, or prescription medications within two (2) weeks of the start of the study;
* Participant is allergic to any ingredient present within the dietary supplement or placebo treatment;
* Participant reports any unusual adverse events associated with this study that, in consultation with the study investigators or the participant's doctor recommends removal from the body;
* Participant fails to comply with the study protocol.

Intervention Below is an overview of the study, including the phases, timepoints, and dependent variables that will be assessed. The total study duration for each subject is approximately fifteen (15) weeks - one (1) week of pre-test familiarization plus fourteen (14) weeks of intervention and testing. Subject testing will commence on a rolling enrollment basis (i.e., all subjects will not start, be tested on, and end the study at the same time).

24 hrs - 12 hrs: Restricted Diet

Discontinue eating:

* All grains (including pasta, bread, cereals)
* Fruits
* Vegetables (including any food products that contain corn, corn starch, etc)
* Nuts and seeds
* Beans/ Legumes
* All dairy products (including cheese, ice cream, butter, and yogurt)
* All meats \[except those approved (below)\]

Allowed foods:

* Baked or broiled chicken, fish or turkey (salt and pepper seasoning only)
* Plain, steamed white rice
* Eggs
* Clear chicken or beef broth
* White bread (only)
* Participants may drink water, coffee, or tea; no sugar or artificial sweetener; no creamer/cream 12 hrs - 0 hrs: Fasting
* Water only
* No sleeping or vigorous exercise for at least (1) hour prior to any time during the breath test

TIMELINE:

Day -7 - 0 - Pre-screening \& Familiarization

* Subjects complete one-week nutrition log via MyFitnessPal Day 0 - Baseline \& Acute Response (Lab Test #1; LT1)
* Subject arrives 12-hr fasted (water only) and having followed the 24hr pre-test and lifestyle protocol -\> Body Mass (BM) and Hydration (urine) measurements -\> 5-minute seated -\> Heartrate (HR) and Blood Pressure (BP) measurements -\> Gastrointestinal Symptom Score -\> Venous Blood collection -\> Non-Alcohol Mouth Rinse -\> Breath Analysis -\> Treatment Dose Consumed with 8-10 fl. oz. H2O -\> 30- minute seated -\> 25-gram Lactose Challenge/Ingestion -\> 60- minute seated -\> Non-Alcohol Mouth Rinse -\> Breath Analysis -\> 60-minute seated -\> Non-Alcohol Mouth Rinse -\> Breath Analysis -\> 60 minute seated -\> Gastrointestinal Symptoms Score -\> Non-Alcohol Mouth Rinse -\> Breath Analysis Day 1 - Day 7 - Treatment Phase
* Subjects consume three (3) servings per day of treatment at scheduled times and conditions for three (3) days -\> On Day 4 subjects perform a Lactose Challenge / Ingestion Test at home after a12-hr fast (water only); Gastrointestinal Symptoms Score is collected prior to, and at 180 minutes postprandial (after lactose ingestion) -\> Subjects continue to consume three (3) servings per day of treatment at scheduled times and conditions for three (3) days
* Subjects complete one-week nutrition log Day 7 - Subacute Response (Lab Test #2; LT2)
* Repeat LT1
* Subjects discontinue treatment Day 8 - Day 37 - 30- Day Post Treatment Phase
* Subjects perform weekly Lactose Challenge/Ingestion Testing at home with Gastrointestinal Symptoms Scoring
* Subjects complete one-week nutrition logs Day 37 - 30-Day Post Treatment Response (Lab Test #3; LT3)
* Repeat LT1/LT2 testing (less the Treatment Dose + 30-minute seating pre-Lactose Challenge / Ingestion) Day 38 - Day 67 - 60-Day Post Treatment Phase
* Subjects perform weekly Lactose Challenge/Ingestion Testing at home with Gastrointestinal Symptoms scoring
* Subjects complete one-week nutrition logs Day 67 - 60- Day Post Treatment Response (Lab Test #4; LT4)
* Repeat LT1/LT2/LT3 testing (less treatment Dose + 30-minute seated pre- Lactose Challenge/Ingestion) Day 68 - Day 97 - 90-Day Treatment Phase
* Subjects perform weekly Lactose Challenge/Ingestion Testing at home with Gastrointestinal Symptoms Scoring
* Subjects complete one-week nutrition logs Day 97 - 90-Day Post Treatment Response (Lab Test #5; LT5)
* Repeat LT1/LT2/LT3/LT4/ testing (less Treatment Dose + 30- minute seating pre- Lactose Challenge/ Ingestion)

Eligibility criteria: Inclusion Criteria:

* Participants will be male or female between the ages of 18-55 years;
* Participants will be apparently healthy and free from disease, as determined by a health history questionnaire;
* Participants will not be excluded if he or she has been clinically diagnosed with a carbohydrate malabsorption disorder, or is or has been prescribed to take prescription or over-the-counter medication for such;
* Participant has self-diagnosed or otherwise avoids consuming dairy, lactose, and other dairy-containing products, or regularly consumes Lactase enzymes for digestive support;
* Participant agrees and can comply with the study protocol;
* Participant provides signed and dated informed consent to participate in the study.

Exclusion Criteria:

* Participant is or may be pregnant, is trying to become pregnant, or is breastfeeding;
* Participant currently uses, or has discontinued the use of nicotine-containing products within twelve (12) months of the start of the study;
* Participant lives or works within an environment that chronically exposes the subject to second-hand smoke;
* Participant currently uses, or has discontinued the use of recreational drugs or medicinal marijuana within twelve (12) months of the start of the study;
* Participant has been clinically diagnosed with a digestive disorder such as gastrointestinal disease, chronic diarrhea or constipation, irritable or inflammatory bowel syndrome, Crohn's disease, or is, or has been prescribed to take prescription or over-the-counter medication for such;
* Participant has ever undergone gastric bypass surgery, or has undergone an abdominal or other gastrointestinal surgery within twelve (12) months of the start of the study;
* Participant is taking, or has taken antibiotic medications within two (2) weeks of the start of the study;
* Participant has undergone a colonoscopy within two (2) weeks of the start of the study, or is scheduled to receive a colonoscopy during the study;
* Participant has undergone a barium study or received an enema within two (2) weeks of the start of the study, or is scheduled to, or receives such during the study;
* Participant is taking, or has taken probiotics within two (2) weeks of the start of the study;
* Participant uses lactose digesting enzymes during the study;
* Participant is taking, or has taken weight loss, prebiotic \[e.g., fructo- or galacto-oligosaccharides (FOS or GOS), psyllium, or insulin fiber, etc.\], or laxative / stool softener dietary supplements, over-the-counter, or prescription medications within two (2) weeks of the start of the study;
* Participant is allergic to any ingredient present within the dietary supplement or placebo treatment;
* Participant reports any unusual adverse events associated with this study that, in consultation with the study investigators or the participant's doctor recommends removal from the study;
* Participant fails to comply with the study protocol.

Primary outcomes:
measure: Lactobacillus Acidophilus MPH734's Effect on lactose digestion in individuals who identify as lactose sensitive, intolerant, or avoid dairy.
timeFrame: 97 days
Secondary outcomes:
Other outcomes:
Locations:
city: Belton
country: United States
facility: University of Mary Hardin-Baylor
state: Texas
Study officials:
References: