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 (LF)
Primary Purpose
Lactose Intolerance
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lactobacillus acidophilus MPH734
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Lactose Intolerance focused on measuring lactose intolerance, probiotic
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.
Sites / Locations
- University of Mary Hardin-BaylorRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Low dose 10 billion CFU per day
High dose 15 billion CFU per day
Arm Description
Taken once prior to the first testing session, 3x a day every day for the 7 days of supplementation, and taken one last time during second testing session.
Taken once prior to the first testing session, 3x a day every day for the 7 days of supplementation, and taken one last time during second testing session.
Taken once prior to the first testing session, 3x a day every day for the 7 days of supplementation, and taken one last time during second testing session.
Outcomes
Primary Outcome Measures
Lactobacillus Acidophilus MPH734's Effect on lactose digestion in individuals who identify as lactose sensitive, intolerant, or avoid dairy.
Primary outcome 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04531033
First Posted
August 18, 2020
Last Updated
November 10, 2020
Sponsor
Lemuel W. Taylor IV
Collaborators
Manzo Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT04531033
Brief Title
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
Acronym
LF
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
August 25, 2021 (Anticipated)
Study Completion Date
August 25, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lemuel W. Taylor IV
Collaborators
Manzo Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lactose Intolerance
Keywords
lactose intolerance, probiotic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 treatments: low dose probiotic, high dose probiotic, placebo
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Taken once prior to the first testing session, 3x a day every day for the 7 days of supplementation, and taken one last time during second testing session.
Arm Title
Low dose 10 billion CFU per day
Arm Type
Experimental
Arm Description
Taken once prior to the first testing session, 3x a day every day for the 7 days of supplementation, and taken one last time during second testing session.
Arm Title
High dose 15 billion CFU per day
Arm Type
Experimental
Arm Description
Taken once prior to the first testing session, 3x a day every day for the 7 days of supplementation, and taken one last time during second testing session.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus acidophilus MPH734
Other Intervention Name(s)
Lacto-FreedomTM, or LF
Intervention Description
After supplementing with oral probiotics, it has been suggested that select probiotics capable of expressing Beta-glucosidase enzyme activity may likewise be effective treatment for lactose intolerance.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
placebo made to match dietary supplement being tested.
Primary Outcome Measure Information:
Title
Lactobacillus Acidophilus MPH734's Effect on lactose digestion in individuals who identify as lactose sensitive, intolerant, or avoid dairy.
Description
Primary outcome 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.
Time Frame
97 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of Mary Hardin-Baylor
City
Belton
State/Province
Texas
ZIP/Postal Code
76513
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Tinnin, MS
Phone
254-295-5569
Email
mtinnin@umhb.edu
First Name & Middle Initial & Last Name & Degree
Jessica Prather, BS
Phone
254-295-5571
Email
jprather@mail.umhb.edu
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs