A Placebo-controlled, Double-blind, Safety and Tolerability Evaluation of BP-LT.

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.

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 \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