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NOT YET RECRUITING
NCT07873957
NA

IgG Binding Protein LT in Support of a Healthy Gut on the Go

Sponsor: Bactolife A/S

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Double-blind, Placebo-controlled Study Evaluating the Impact of Daily Supplementation With IgG Binding Protein LT in Support of a Healthy Gut on the Go

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

800

Start Date

2026-10-15

Completion Date

2027-11

Last Updated

2026-10-14

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

IgG Binding Protein LT

Dietary supplement containing IgG Binding Protein LT

DIETARY_SUPPLEMENT

Placebo

Dietary supplement without IgG Binding Protein LT

Locations (1)

People Science In.c.

Los Angeles, California, United States