Does Daily Supplementation of Lactobacillus Acidophilus MPH734, for One Week, Affect Acute (Immed… (NCT04531033) | Clinical Trial Compass
CompletedNot Applicable
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
United States50 participantsStarted 2020-08-25
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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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 pr…
What they're measuring
1
Lactobacillus Acidophilus MPH734's Effect on lactose digestion in individuals who identify as lactose sensitive, intolerant, or avoid dairy.