Safety and Tolerability Evaluation of BP-LT

NCT07819695 | Not Yet Recruiting DMC

• 1 other identifier: PR-25057
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the safety and tolerability of the food ingredient 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 Part I of a two-part clinical development program: two sequential, randomized, double-blind, placebo-controlled safety and tolerability cohorts conducted at a clinical research site in Dhaka, Bangladesh. Cohort 1 enrolls 20 healthy adult volunteers aged \>18 to ≤60 years (8-12 male, 8-12 female); Cohort 2 enrolls 20 healthy children aged \>3 to ≤18 years. The cohorts are run sequentially in age-descending order: Cohort 2 opens only after an independent Data Safety Monitoring Board (DSMB) reviews the Cohort 1 results and confirms that BP-LT has an acceptable safety and tolerability profile.

Conditions

Safety and Tolerability in Healthy Volunteers

Keywords

BP-LT

Outcome Measures

Primary Outcomes (1)

• Incidence of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) per arm, by product causality.

  Incidence of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) per arm, by product causality.

  From baseline (Day 0) to Day 7

Study Arms (2)

BP-LT

EXPERIMENTAL

Received test product containing BP-LT

Dietary Supplement: BP-LT

Placebo

PLACEBO COMPARATOR

Received placebo product without BP-LT

Dietary Supplement: Placebo

Interventions

BP-LT DIETARY_SUPPLEMENT

Dietary supplement containing BP-LT

BP-LT

Placebo DIETARY_SUPPLEMENT

Dietary supplement without BP-LT

Placebo

Eligibility Criteria

• Age: 3 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adult male and female of any race or ethnicity
• Age between \>18 and ≤60 years
• Body mass index: 18.5 to 28
• Generally healthy with no diarrhea or other illness in the preceding 2 weeks
• Providing informed written consent

You may not qualify if:

• Diarrhea within last 7 days
• Smoker or using betel leaf with tobacco (e.g. chewing-tobacco: Jorda, Shada-pata, Gul etc.)
• Current systemic infection requiring antibiotic treatment
• Unwilling to comply with study procedures
• Currently or have participated in another clinical study the preceding 4 weeks
• History of laxative use within 7 days
• History of abuse of drugs or alcohol
• Pregnant or lactating mother
• Clinically significant abnormalities in medical history, physical examination, vital signs, haematology, clinical chemistry results, or other laboratory abnormalities
• Testing positive for hepatitis C and/or B
• Children of any sex, race or ethnicity
• Age between \>3 to ≤18 years
• Body mass index for age z-score: ≥ -2 to \<2 (for \>5 to 18 years old)
• Weight-for-height z-score: \> -2 to +2 (for \>3 to 5 years old)
• Generally healthy with no diarrhea or other illness in the preceding 2 weeks

Sponsors & Collaborators

• Bactolife A/S: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Signifikans ApS: collaborator

Study Sites (1)

The International Centre for Diarrheal Disease Management in Bangladesh (icddr,b)

Dhaka, 1212, Bangladesh

Location

Study Officials

• Shafiqul A Sarker, Dr.

  The International Centre for Diarrheal Disease Management in Bangladesh (icddr,b)

  PRINCIPAL INVESTIGATOR

• Iqbal Hossain, Dr.

  The International Centre for Diarrheal Disease Management in Bangladesh (icddr,b)

  PRINCIPAL INVESTIGATOR

• Shamima Sultana, Dr.

  The International Centre for Diarrheal Disease Management in Bangladesh (icddr,b)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shafiqul A Sarker, Dr.

CONTACT

(0)2-2222-77001; sasarker@icddrb.org

Shamima Sultana, Dr.

CONTACT

(0)2-2222-77001; shamima@icddrb.org

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 9, 2026
• First Posted: September 15, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)