Safety and tolerability test of BP-LT when added to daily diet

Is this trial a fit for you?

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

What this trial studies

This interventional study evaluates the safety and tolerability of BP-LT, a stable protein ingredient that remains in the gut without systemic absorption. It uses two sequential, randomized, double-blind, placebo-controlled cohorts: adults aged 18 to 60 and children aged 3 to 18, conducted at icddr,b in Dhaka. Participants receive BP-LT or placebo as two daily 5 g sticks for 7 days while housed in a study ward, with comprehensive screening and safety monitoring, including hematology, chemistry, and adverse event tracking. Stool samples are collected for exploratory gut microbiome analysis to assess potential microbiome effects. The primary goal is to compare adverse events and lab findings between BP-LT and placebo; the secondary goal is to observe changes in gut microbiome stability and diversity. Cohort 2 opens only after DSMB review of Cohort 1 results confirming acceptable safety.

Why it matters

Who can join: the full rules

Cohort 1 Inclusion criteria

* 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
* Capable and willing to stay 7 days continuously at the Study Ward of icddr,b and complete all study visits and all procedures required by the protocol Exclusion criteria
* 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
* Known allergy to any of the ingredients in the study product Cohort 2 Inclusion criteria
* 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
* Providing informed written consent from either parents or guardian (thumb impression for those who are not literate) for children below 11 years, and assent from children aged 11 to ≤18 years
* Capable and willing to stay 7 days continuously at the Study Ward of icddr,b and complete all study visits and all procedures required by the protocol along with their legal guardian Exclusion criteria
* Diarrhea within last 7 days
* Current systemic infection requiring antibiotic treatment
* Unwilling to comply with study procedures
* Currently or have participated in another clinical study the preceding 4 weeks
* Antibiotic treatment during the preceding 2 weeks
* 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
* Known allergy to any of the ingredients in the study product

Where it's running

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

Study contacts

• Principal investigator: Shafiqul A Sarker, Dr. — The International Centre for Diarrheal Disease Management in Bangladesh (icddr,b)
• Study coordinator: Shafiqul A Sarker, Dr.
• Email: sasarker@icddrb.org
• Phone: (0)2-2222-77001

Similar studies

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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.