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Clinical trial Recruiting at 1 site Interventional Ages 18 to 70

IgG Binding Protein LT for gut health during travel

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

Run by Bactolife A/S · NCT07873957 · Data updated 2026-11-12

This study tests whether IgG Binding Protein LT helps healthy adults maintain gut health while traveling internationally.

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Quick facts

Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment800 (estimated)
SponsorBactolife A/S
Industry-sponsored
Locations1 site (Los Angeles, California)
StatusRecruiting
StartedOctober 12, 2026
Main results expectedOctober 2027
Study endsNovember 2027
Registry record updatedOctober 20, 2026
Trial IDNCT07873957 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–70 who are generally healthy, have more than 3 bowel movements in a week, and plan a 7–21 day international trip to Africa, Asia, or Latin America/the Caribbean.

Probably not a fit

Participants with significant health issues or those not experiencing travel-related gut symptoms may see no clear benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled, fully decentralized trial to see if IgG Binding Protein LT supports gut health in healthy adults aged 18–70 who are traveling abroad for 7 to 21 days. Participants are assigned to BP-LT or placebo and take 150 mg per day in two 75 mg capsules with meals during travel, with outcomes collected remotely. Primary outcome is change in GSRS total score from baseline to end of travel; secondary endpoints include stool patterns, gut microbiome and inflammation markers, appetite, cognitive function, safety, and infection outcomes. Recruitment prioritizes travelers to higher-risk Tier 1 countries, and an interim analysis may expand the sample size based on conditional power between 0.30 and 0.80. The study uses online consent, at-home sample collection, and remote assessments over roughly 23 weeks total.

Why it matters

Potential benefit: If successful, BP-LT could help travelers maintain gut comfort and general well-being during international trips.

How similar studies have gone: Prior work in similar gut-health interventions has shown signals of benefit, but this approach is being tested in a travel-specific, fully decentralized design.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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 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)

     * 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
7. 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.
8. 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.
9. Able to receive shipment of the product at an address within the United States.
10. Able to complete study Pre-Screening Survey, Screening assessments, and 4 weeks of activities after starting Study Product/Placebo use.

Exclusion Criteria:

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:

1. Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder
2. Currently pregnant, planning to become pregnant during participation in the study, or are lactating/breastfeeding.
3. Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes.
4. 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:

1. 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).
2. Has a male sexual partner who is surgically sterilized prior to Screening and is the only male sexual partner for that Participant.
3. Sexual partner(s) is/are exclusively female.
4. 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.
5. 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:

1. IgG Binding Protein LT (BP-LT)
2. Microcrystalline cellulose
3. 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:

1. Diagnosed gastrointestinal conditions
2. Immunocompromised health conditions
3. 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:

1. Systemic antibiotics -in the past 12 weeks prior to Screening
2. Proton pump inhibitors (PPIs) - in the past 4 weeks prior to Screening
3. 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:

1. Probiotics
2. Prebiotics
3. Synbiotics
4. 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.

Where it's running

  • People Science In.c.
    Los Angeles, California, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.