An interventional study of Lactobacillus acidophilus MPH734 and Placebo in Lactose Intolerance, sponsored by Lemuel W. Taylor IV. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Lemuel W. Taylor IV · Not applicable, Interventional, and Prevention
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.
Participants will be included and/or excluded in the study based on the criteria below:
Inclusion Criteria
Subject Exclusion Criteria
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:
Allowed foods:
TIMELINE:
Day -7 - 0 - Pre-screening \& Familiarization
53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.
This study's enrollment of 50 is above the median of 41 across 41 interventional studies indexed under Lactose Intolerance.
Browse Lactose Intolerance studies →This is the only study on the registry with Lemuel W. Taylor IV as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Also known as: Lacto-FreedomTM, or LF
placebo made to match dietary supplement being tested.
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.
Time frame: 97 days
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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