An interventional study of BP-LT and Placebo in Safety and Tolerability in Healthy Volunteers, sponsored by Bactolife A/S. Recruiting at 1 site in Bangladesh. Open to participants aged 3 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Bactolife A/S · Not applicable, Interventional, and Other
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.
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.
Bactolife A/S is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cohort 1 Inclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Received test product containing BP-LT
Dietary Supplement: BP-LT
Received placebo product without BP-LT
Dietary Supplement: Placebo
Dietary supplement containing BP-LT
Dietary supplement without BP-LT
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 7
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2026 (actual). Primary completion is estimated for Mar 2027, 4 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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