Bactolife A/S
PS52 is a randomized, double-blind, placebo-controlled, fully decentralized study sponsored by Bactolife A/S and conducted by People Science, Inc. It evaluates whether IgG Binding Protein LT (BP-LT), supports gut health in healthy US adults aged 18-70 travelling 7-21 days to Africa, Asia or Latin America/Caribbean countries. Participants are randomized 1:1 to BP-LT (one 75 mg capsule twice daily with food, 150 mg/day) or a matching placebo for the length of their trip. The primary endpoint is the change in GSRS total score from Baseline to End-of-Study versus placebo. Secondary endpoints cover stool frequency and consistency, gut microbiome and inflammation markers, appetite, cognitive function, safety, and outcomes in travellers who test positive for E. coli. Part 1 enrols 100-250 participants, and an interim analysis may expand the study to a maximum of 800 participants.
Design and duration: Recruitment is balanced by sex and age, and participants travelling to higher-risk Tier 1 countries are prioritized. Capsules are taken after breakfast and after dinner from a 50-capsule jar labelled in a blinded manner. Total participation duration spans up to about 23 weeks: pre-screening and screening (up to 4 weeks each), a pre-travel hold with randomization and shipping (up to 2 weeks before departure), a 14-day home baseline, product use while travelling, and a 7-day end-of-study period on return (by Day 42). After Part 1, an independent statistician assesses conditi…
Inclusion Criteria: 1. 18-70 years of age, inclusive, or the legal age of majority in the participant's state of residence (e.g., 19 years for Alabama and Nebraska; 21 years for Mississippi). 2. In good general health at the time of screening (Investigator discretion). 3. Able to read and understand English. 4. Able to read, understand, and provide informed consent. 5. Reports more than 3 bowel movements in a 7 day period. 6. Planning international travel to Africa, Asia or Latin America/The Caribbean for a duration of 7 to 21 days. a. The participant must spend a minimum 7 days in one of the…
Dietary supplement containing IgG Binding Protein LT
Dietary supplement without IgG Binding Protein LT
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