Gut-Acting protein BP-LT put to the test for safety

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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