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)

May 14, 2024 updated by: Lemuel W. Taylor IV

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?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Belton, Texas, United States, 76513
        • University of Mary Hardin-Baylor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
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.
Dietary supplement: Placebo
placebo made to match dietary supplement being tested.
Experimental: Low dose 10 billion CFU per day
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.
Dietary supplement: Lactobacillus acidophilus MPH734
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.
Other Names:
  • Lacto-FreedomTM, or LF
Experimental: High dose 15 billion CFU per day
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.
Dietary supplement: Lactobacillus acidophilus MPH734
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.
Other Names:
  • Lacto-FreedomTM, or LF

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lactobacillus Acidophilus MPH734's Effect on lactose digestion in individuals who identify as lactose sensitive, intolerant, or avoid dairy.
Time Frame: 97 days
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.
97 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lemuel W. Taylor IV

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Manzo Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 25, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 14, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LF-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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