An interventional study of IgG Binding Protein LT and Placebo in Gut Health, Gastrointestinal Symptoms and Safety in Healthy Adults, sponsored by Bactolife A/S. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Bactolife A/S · Not applicable, Interventional, and Other
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 conditional power in an interim analysis, and the study expands only if the result falls in the 0.30-0.80 power range, up to a maximum of 800 participants in total.
Conduct and assessments: Participants are recruited online through a landing page and pre-screening questionnaire, and consent electronically in People Science's "Chloe" app. There is no in-person clinician contact; participants record their stool form (Bristol scale), stool frequency and compliance daily, and answer an adverse event question weekly. They complete the GSRS, DQLQ and PROMIS Cognitive Function 8a at baseline, at week 2 (for trips over 14 days) and at end-of-study. At-home finger-prick blood spots (SiPhox: hs-CRP, cortisol, BUN, creatinine, albumin) and rectal-swab stool kits (microbiome diversity, LPS, H₂S and mucus-degradation indices, E. coli qPCR) are collected at baseline and end-of-study.
Eligibility and safety: Key exclusions include GI or immunocompromising conditions, antibiotics within 12 weeks, PPIs within 4 weeks, certain vaccinations within the last 24 months, pregnancy, and pro-/prebiotic use during the study. Physician sub-investigators provide remote medical oversight, including for participants abroad.
Bactolife A/S is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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.
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 target countries and a maximum of 21 outside of the US.
b. Participant recruitment will prioritize individuals traveling to Tier 1 countries over those traveling to Tier 2 countries.
c. The target countries include:
Africa: (All Tier 1 except South Africa)
Asia:
Latin America \& the Caribbean ● Argentina ● Bolivia (Tier 1) ● Brazil (Tier 1) ● Chile (Tier 1) ● Colombia (Tier) ● Costa Rica ● Cuba ● Dominican Republic ● Ecuador (Tier 1) ● El Salvador (Tier 1) ● Guatemala (Tier 1) ● Haiti (Tier 1) ● Honduras (Tier 1) ● Jamaica ● Mexico (Tier 1) ● Nicaragua (Tier 1) ● Panama ● Paraguay (Tier 1) ● Peru (Tier 1) ● The Bahamas ● Trinidad and Tobago ● Uruguay
Exclusion Criteria:
11. Do not have a personal smartphone, internet access, or unwilling to download Chloe.
12. Concomitant Therapies: 1. Participants receiving any therapies or treatments within 30 days prior to randomization.
13. Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded:
14. Have taken an oral cholera vaccine or taken part in studies on ETEC vaccines ie. ETVAX within the last 24 months 15. Subjects which have been diagnosed with ETEC or cholera diarrhea within a 5-year period 16. Participants of biological must adhere to a continuous effective method of . Pregnancy status must be confirmed via the electronic Pregnancy Survey at Screening, Baseline, and End-of-Study. Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
17. Known or previous allergic reaction to the study product and placebo ingredients:
18. Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history. Excluded health conditions include:
19. Current or recent use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:
20. Restrictions during study participation: Participants must refrain from initiating or using any of the following prohibited supplements during the study period include:
21. Current, recent (in the past 4 weeks prior to Screening) or planned use during study participation of prohibited nutritional or non-nutritional supplements that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results.
22. Are unlikely for any reason to be able to comply with the study or considered unsuited for participation in the study by the Principal Investigator.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Received oral capsules twice daily containing IgG Binding Protein LT
Dietary Supplement: IgG Binding Protein LT
Received oral Placebo capsules twice daily without IgG Binding Protein LT
Dietary Supplement: Placebo
Dietary supplement containing IgG Binding Protein LT
Dietary supplement without IgG Binding Protein LT
Change from Baseline to End-of-Study in Gastrointestinal Symptom Rating Scale (GSRS) total score in the IgG Binding Protein LT group versus the Placebo group.
The GSRS (Gastrointestinal Symptom Rating Scale) is a questionnaire that measures the severity of gastrointestinal symptoms, such as abdominal pain, heartburn, indigestion, diarrhea, and constipation. It contains 15 questions, each scored from 1 to 7. Therefore, the minimum total score is 15 (fewest or no symptoms) and the maximum score is 105 (most severe symptoms).
Time frame: From baseline (1-14 days after randomization) to End-of-Study (22-42 days after randomization, depending on travel duration)
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Oct 2027, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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