Safety and Tolerability in Healthy Volunteers
Conditions
Keywords
BP-LT
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.
Detailed description
Within each cohort, participants are randomized 1:1 to a Test product (a food stick pack containing 70 mg BP-LT per 5 g pack, two packs daily) or an identical Placebo product without BP-LT, taken twice daily for 7 days while resident at the study ward. Screening (day -7 to -1) includes medical history, physical examination, vital signs, hematology, clinical chemistry, hepatitis B/C testing, and stool culture to confirm participants are free of common enteric bacterial pathogens. Blood for hematology and clinical chemistry is repeated on day 7. Participants are monitored throughout for vital signs and for anorexia, nausea, vomiting, diarrhea, itching, and urticaria/rash. Stool samples are also collected for exploratory gut microbiome analysis (16S rRNA sequencing) at baseline and end of intervention. Primary objective: To determine the safety and tolerability of BP-LT, comparing the Test product to Placebo, in healthy volunteers aged \>3 to 60 years. Safety is defined as no significant over-representation of adverse events or abnormal hematology/biochemistry findings in the Active arm versus Placebo; tolerability is defined as overall well-being and no significant over-representation of anorexia, nausea, vomiting, diarrhea, itching, or compromised study-product compliance in the Active arm versus Placebo. Secondary objective: To determine whether twice-daily intake of BP-LT for 7 days supports a stable and diverse gut microbiome in adults and children. Neither participants, investigators, caregivers, the Sponsor, nor laboratory personnel are aware of treatment allocation until database lock and blinded data review are complete; emergency unblinding procedures are available if medically required. Findings from Cohort 1 and Cohort 2 will determine DSMB approval to proceed to the next stage of the development program.
Interventions
DIETARY_SUPPLEMENTBP-LT
Dietary supplement containing BP-LT
DIETARY_SUPPLEMENTPlacebo
Dietary supplement without BP-LT
Sponsors
Bactolife A/S
International Centre for Diarrhoeal Disease Research, Bangladesh
Signifikans ApS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The Sponsor Bactolife
Eligibility
Sex/Gender
ALL
Age
3 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Incidence of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) per arm, by product causality. |
Countries
Bangladesh
Contacts
CONTACTShafiqul A Sarker, Dr.
CONTACTShamima Sultana, Dr.
PRINCIPAL_INVESTIGATORShafiqul A Sarker, Dr.
The International Centre for Diarrheal Disease Management in Bangladesh (icddr,b)
PRINCIPAL_INVESTIGATORIqbal Hossain, Dr.
The International Centre for Diarrheal Disease Management in Bangladesh (icddr,b)
PRINCIPAL_INVESTIGATORShamima Sultana, Dr.
The International Centre for Diarrheal Disease Management in Bangladesh (icddr,b)
Outcome results
None listed