Safety and Tolerability in Healthy VolunteersNCT07819695
Safety and Tolerability Evaluation of BP-LT
A study testing BP-LT in people with Safety and Tolerability in Healthy Volunteers, run by Bactolife A/S at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability in Healthy Volunteers
- What is being tested?
- BP-LT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBangladesh
- Study dates
- 3 Nov 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
The International Centre for Diarrheal Disease Management in Bangladesh (icddr,b)
Dhaka, 1212
Shamima Sultana, Dr., (0)2-2222-77001 ext. +880, shamima@icddrb.org
Shafiqul A Sarker, Dr., (0)2-2222-77001 ext. +880, sasarker@icddrb.org
About this study
Official title: Safety and Tolerability of the Food Ingredient BP-LT in Healthy Human Volunteers
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.
Read the 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.
- Being tested
- BP-LT, Placebo
- Keywords
- BP-LT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP-LTDietary supplement
Dietary supplement containing BP-LT
PlaceboDietary supplement
Dietary supplement without BP-LT
| Study group | Role | What they receive |
|---|---|---|
| BP-LT | Experimental | Received test product containing BP-LT Receives: Dietary Supplement: BP-LT |
| Placebo | Placebo comparator | Received placebo product without BP-LT Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (Day 0) to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start3 Nov 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Tolerability in Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bactolife A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Signifikans ApS
- Responsible party
- Sponsor
- Investigators
- Shafiqul A Sarker, Dr., Principal investigator, The International Centre for Diarrheal Disease Management in Bangladesh (icddr,b)Iqbal Hossain, Dr., Principal investigator, The International Centre for Diarrheal Disease Management in Bangladesh (icddr,b)Shamima Sultana, Dr., Principal investigator, The International Centre for Diarrheal Disease Management in Bangladesh (icddr,b)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819695
- Sponsor's protocol ID
- PR-25057
- Status last verified
- Nov 2026
- First submitted
- 9 Sep 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of the Food Ingredient BP-LT in Healthy Human Volunteers
- ClinicalTrials.gov ID
- NCT07819695
- Acronym / sponsor ID
- PR-25057
- Keywords
- BP-LT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bactolife A/SIndustry (pharma, biotech, devices)
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Signifikans ApS
- Study start
- 3 Nov 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BP-LT | Experimental | Dietary Supplement: BP-LTReceived test product containing BP-LT |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboReceived placebo product without BP-LT |
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BP-LTDietary supplement containing BP-LT | Dietary supplement | BP-LT |
| PlaceboDietary supplement without BP-LT | Dietary supplement | Placebo |
Primary outcome
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
Incidence of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) per arm, by product causality.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shafiqul A Sarker, Dr. principal investigator
The International Centre for Diarrheal Disease Management in Bangladesh (icddr,b)
Iqbal Hossain, Dr. principal investigator
The International Centre for Diarrheal Disease Management in Bangladesh (icddr,b)
Shamima Sultana, Dr. principal investigator
The International Centre for Diarrheal Disease Management in Bangladesh (icddr,b)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BP-LT in people with Safety and Tolerability in Healthy Volunteers, run by Bactolife A/S at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shafiqul A Sarker, Dr. ((0)2-2222-77001 ext. +880, sasarker@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.