Recruiting

BP-LT

Sponsor:

Bactolife A/S

Code:

NCT07824011

Conditions

Safety and Tolerability in Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

IgG Binding Protein LT

Placebo

Study Details

Brief summary:

This study evaluates the safety and tolerability of the food ingredient IgG Binding Protein LT (BP-LT) when added to a daily diet. BP-LT is a stable protein ingredient being functional in the gastrointestinal tract and without systemic absorption. This registration covers a decentralized, randomized, double-blind, placebo-controlled clinical study evaluating BP-LT in healthy adults.

Conditions

Safety and Tolerability in Healthy Volunteers

Study ID

NCT07824011

Start date

Oct 12, 2026

Status verified date

Sep, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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. Self reports more than 3 bowel movements in the Chloe App in a 7 day period before or during screening.
6. Able to consume one capsule (allergen and vegan friendly) the Study Product or Placebo twice daily, not on an empty stomach. The first capsule will be consumed in the morning after breakfast and the second in the evening after dinner.
7. Able to use a personal smartphone device and download Chloe by People Science.
8. Able to receive shipment of the product at an address within the United States.
9. Able to complete study assessments over the course of up to 11 weeks.

Exclusion Criteria:

Any potential participants who:

1. Do not have a personal smartphone, internet access, or unwilling to download Chloe.
2. Concomitant Therapies:

• Participants receiving any investigational therapies or treatments within 30 days prior to randomization.
3. 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, of childbearing potential, 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.
  • 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.
4. 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 when they complete last study activities).
  • Has a male sexual partner who is surgically sterilized prior to the 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, hysterectomy, oophorectomy, or salpingectomy, 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 the screening, throughout the study, and two weeks following the end of the study.
5. Known hypersensitivity or previous allergic reaction to the study product ingredients:

  • IgG Binding Protein LT (BP-LT)
  • Microcrystalline cellulose
  • Magnesium stearate
6. Has any significant acute or chronic coexisting health conditions that would prevent the Participant 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).
7. 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.
8. 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.
9. 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
10. Planning to make significant dietary or lifestyle changes during the study period (e.g., travel, new diet).
11. 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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: IgG Binding Protein LT

Received oral capsules twice daily containing IgG Binding Protein LT

placebo comparator: Placebo

Received oral Placebo capsules twice daily without IgG Binding Protein LT

Interventions

IgG Binding Protein LT

Dietary supplement containing IgG Binding Protein LT

Placebo

Dietary supplement without IgG Binding Protein LT

Primary outcome measure

  • To evaluate the safety and tolerability of a 3-week, twice-daily intake of IgG Binding Protein LT (BP-LT) in healthy adults. [ Time Frame: From Baseline to Week 4 ]

Central Contacts and Locations

Locations

People Science In.c.

Recruiting

Los Angeles, California, United States, 90045

Contacts

More Information

Sponsor

Bactolife A/S

Last update posted

Oct 16, 2026

Last verified

Sep, 2026

Keywords

  • IgG Binding Protein LT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Bactolife A/S on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.