Safety and Tolerability Evaluation of BP-LT
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-60
SponsorBactolife A/S
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
BP-LT
Dietary supplementDietary supplement containing BP-LT
Placebo
Dietary supplementDietary supplement without BP-LT
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: BP-LTExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
From baseline (Day 0) to Day 7Sponsors and contacts
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Bactolife A/S
Lead sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborator
Signifikans ApS
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: