Safety and Tolerability Evaluation of IgG Binding Protein LT

NCT07824011 | Not Yet Recruiting

• 1 other identifier: PS47
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

IgG Binding Protein LT

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of a 3-week, twice-daily intake of IgG Binding Protein LT (BP-LT) in healthy adults.

  The incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) per product causality.

  From Baseline to Week 4

Study Arms (2)

IgG Binding Protein LT

EXPERIMENTAL

Received oral capsules twice daily containing IgG Binding Protein LT

Dietary Supplement: IgG Binding Protein LT

Placebo

PLACEBO COMPARATOR

Received oral Placebo capsules twice daily without IgG Binding Protein LT

Dietary Supplement: Placebo

Interventions

IgG Binding Protein LT DIETARY_SUPPLEMENT

Dietary supplement containing IgG Binding Protein LT

IgG Binding Protein LT

Placebo DIETARY_SUPPLEMENT

Dietary supplement without IgG Binding Protein LT

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Self reports more than 3 bowel movements in the Chloe App in a 7 day period before or during screening.
• 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.
• Able to use a personal smartphone device and download Chloe by People Science.
• Able to receive shipment of the product at an address within the United States.
• Able to complete study assessments over the course of up to 11 weeks.

You may not qualify if:

• Any potential participants who:
• Do not have a personal smartphone, internet access, or unwilling to download Chloe.
• Concomitant Therapies:
• Participants receiving any investigational therapies or treatments within 30 days prior to randomization.
• 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.
• 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.

Sponsors & Collaborators

• Bactolife A/S: lead
• People Science, Inc.: collaborator

Study Sites (1)

People Science In.c.

Los Angeles, California, 90045, United States

Location

Study Officials

• Ashley Mateus, Ph.D

  People Science, In.c.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Kohan

CONTACT

213-342-5681; jkohan@peoplescience.health

Ashley Mateus, Ph.D

CONTACT

213-342-5681; ashley@peoplescience.health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Sponsor Bactolife
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)