Gut HealthNCT07873957
IgG Binding Protein LT in Support of a Healthy Gut on the Go
A study testing IgG Binding Protein LT in people with Gut Health and Gastrointestinal Symptoms, run by Bactolife A/S at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Health, Gastrointestinal Symptoms, Safety in Healthy Adults
- What is being tested?
- IgG Binding Protein LT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2026to Nov 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
- In good general health at the time of screening (Investigator discretion).
- Able to read and understand English.
- Able to read, understand, and provide informed consent.
- Reports more than 3 bowel movements in a 7 day period.
- 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.
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- Participant recruitment will prioritize individuals traveling to Tier 1 countries over those traveling to Tier 2 countries.
- The target countries include:
- Africa: (All Tier 1 except South Africa)
- Algeria
- Angola
- Benin
- Botswana
- Burkina Faso
- Burundi
- Cabo Verde
- Cameroon
- Central African Republic
- Chad
- Comoros
- Democratic Republic of the Congo
- Republic of the Congo
- Djibouti
- Egypt
- Equatorial Guinea
- Eritrea
- Eswatini
- Ethiopia
- Gabon
- Gambia
- Ghana
- Guinea
- Guinea-Bissau
- Ivory Coast
- Kenya
- Lesotho
- Liberia
- Libya
- Madagascar
- Malawi
- Mali
- Mauritania
- Mauritius
- Morocco
- Mozambique
- Namibia
- Niger
- Nigeria
- Rwanda
- Sao Tome and Principe
- Senegal
- Seychelles
- Sierra Leone
- Somalia
- South Africa
- South Sudan
- Sudan
- Tanzania
- Togo
- Tunisia
- Uganda
- Zambia
- Zimbabwe
- Asia:
- Afghanistan (Tier 1)
- Bahrain
- Bangladesh (Tier 1)
- Bhutan (Tier 1)
- Brunei
- Cambodia (Tier1)
- India (Tier 1)
- Indonesia (Tier 1)
- Iran
- Iraq
- Jordan (Tier 1)
- Kazakhstan
- Laos
- Lebanon
- Malaysia (Tier 1)
- Maldives
- Mongolia
- Myanmar (Tier1)
- Nepal (Tier 1)
- Oman
- Pakistan (Tier 1)
- Palestine
- Philippines (Tier 1)
- Saudi Arabia
- Singapore
- South Korea
- Sri Lanka (Tier 1)
- Syria (Tier 1)
- Tajikistan
- Thailand
- Timor-Leste (Tier 1)
- Turkey (Tier 1)
- Turkmenistan
- United Arab Emirates
- Vietnam (Tier 1)
- Yemen (Tier 1)
- 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
- Venezuela
- Able to consume one capsule (vegan friendly) of the Study Product or Placebo twice daily, not on an empty stomach. The first capsule will be consumed in the morning and the second in the evening.
- Able to use a personal smartphone device and download Chloe by People Science and able to access the Chloe using Wi-Fi/Cellular connection while traveling.
- Able to receive shipment of the product at an address within the United States.
- Able to complete study Pre-Screening Survey, Screening assessments, and 4 weeks of activities after starting Study Product/Placebo use.
Who cannot join
- 11. Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- 12. Concomitant Therapies: 1. Participants receiving any investigational 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:
- Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder
- Currently pregnant, planning to become pregnant during participation in the study, or are lactating/breastfeeding.
- Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes.
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- Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes.
- 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 childbearing potential must adhere to a continuous effective method of contraception. 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:
- Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where the participant discontinues the study prematurely. (Participants utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks of completing end of study activities).
- Has a male sexual partner who is surgically sterilized prior to Screening and is the only male sexual partner for that Participant.
- Sexual partner(s) is/are exclusively female.
- Use of acceptable methods of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study.
- Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to Screening, throughout the study, and two weeks following the end of the study.
- 17. Known hypersensitivity or previous allergic reaction to the study product and placebo ingredients:
- IgG Binding Protein LT (BP-LT)
- Microcrystalline cellulose
- Magnesium stearate
- 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:
- Diagnosed gastrointestinal conditions
- Immunocompromised health conditions
- Answering "Severe Discomfort" or "Very Severe Discomfort" on any question in the Gastrointestinal Symptom Rating Scale (GSRS).
- 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:
- Systemic antibiotics -in the past 12 weeks prior to Screening
- Proton pump inhibitors (PPIs) - in the past 4 weeks prior to Screening
- Non-steroidal anti-inflammatory drugs (NSAIDs) - in the past 2 weeks prior to Screening. Participants are allowed to use NSAIDs after Screening.
- 20. Restrictions during study participation: Participants must refrain from initiating or using any of the following prohibited supplements during the study period include:
- Probiotics
- Prebiotics
- Synbiotics
- Postbiotics Participants are allowed to use the above after Screening.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
People Science In.c.
Los Angeles, California, 90045
Jane Kohan, 213-342-5681, jkohan@peoplescience.health
Ashley Mateus, 213-342-5681, ashley@peoplescience.health
About this study
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
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.
Read the detailed description
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.
- Being tested
- IgG Binding Protein LT, Placebo
- Keywords
- IgG Binding Protein LT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgG Binding Protein LTDietary supplement
Dietary supplement containing IgG Binding Protein LT
PlaceboDietary supplement
Dietary supplement without IgG Binding Protein LT
| Study group | Role | What they receive |
|---|---|---|
| IgG Binding Protein LT | Experimental | Received oral capsules twice daily containing IgG Binding Protein LT Receives: Dietary Supplement: IgG Binding Protein LT |
| Placebo | Placebo comparator | Received oral Placebo capsules twice daily without IgG Binding Protein LT Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline (1-14 days after randomization) to End-of-Study (22-42 days after randomization, depending on travel duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start12 Oct 2026
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bactolife A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Responsible party
- Sponsor
- Investigators
- Ashley Mateus, Principal investigator, People Science, In.c.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873957
- Sponsor's protocol ID
- PS52
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No