- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01899378
Safety and Efficacy of Probiotics in Bangladeshi Infants
October 13, 2016 updated by: Julie Parsonnet, Stanford University
Here the investigators propose to preliminarily investigate the safety and effects of probiotics in infants in Bangladesh through a pilot randomized clinical trial.
The investigators hypothesize that two probiotics are safe for infants in Bangladesh and may have an effect on biomarkers of gut health and immunity.
The specific aims of this pilot are: i) to confirm the safety of administering probiotic strains to infants in low-income countries, ii) to determine the effects of dosing frequency on colonization and persistence of probiotics in the GI tract, iii) to measure markers of intestinal and immune function and microbiota structure.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dhaka, Bangladesh
- International Center for Diarrheal Disease Research, Bangladesh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 3 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy infants.
- Infants 1 -3 months of age at the beginning of the study.
- Parents/guardians of each subject are able to understand study procedures and agree to participate in the study by giving consent.
- Parents and child are planning to remain in Dhaka for the next four months.
Exclusion Criteria:
- Infants with known birth defects.
- Infants who have been hospitalized.
- Infants who have an acute infection or illness at the time of enrolment.
- Infants who are currently taking antibiotics
- Infants <1 month of age or >3 months of age.
- Infants three standard deviations below mean on anthropometric measures (will be referred for medical care).
- Infants who are already receiving a probiotic product or treatment.
- A diagnosis or suspicion of immunodeficiency disorder.
- A diagnosis or suspicion of bleeding disorder that would contraindicate venipuncture.
- Family residence outside of Dhaka or families expecting to move outside of Dhaka in the next 4 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control
|
|
Experimental: daily probiotic
10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis daily for one month
|
10^8 CFU
Other Names:
10^9 CFU
Other Names:
|
Experimental: weekly probiotic
10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis weekly for one month
|
10^8 CFU
Other Names:
10^9 CFU
Other Names:
|
Experimental: bi-weekly probiotic
10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis bi-weekly for one month
|
10^8 CFU
Other Names:
10^9 CFU
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of probiotic in the stool
Time Frame: weeks 0-12
|
presence of absence of each probiotic in the stool
|
weeks 0-12
|
Adverse events
Time Frame: duration of study - through study completion
|
Any adverse or allergic reactions after probiotic administration, hospitalizations, GI and respiratory symptoms
|
duration of study - through study completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quantity of probiotic in the stool
Time Frame: weeks 0-12
|
amount of each probiotic present in the stool
|
weeks 0-12
|
composition of microbiota
Time Frame: weeks 0-12
|
microbial community composition
|
weeks 0-12
|
clinical effects
Time Frame: daily for 7 days after first probiotic administration, then weeks 2-12
|
fever, diarrhea, wheezing, rash, stool frequency, feeding frequency
|
daily for 7 days after first probiotic administration, then weeks 2-12
|
gut function
Time Frame: months 0, 1, 2, 3
|
lactulose/mannitol ratio
|
months 0, 1, 2, 3
|
gut inflammation
Time Frame: months 0,1,2,3
|
fecal neopterin, alpha-1 antitrypsin, and myeloperoxidase - correlated with future growth
|
months 0,1,2,3
|
gut inflammation/translocation
Time Frame: months 0, 1, 2, 3
|
IL22, CD-14, total IgG and c-reactive protein
|
months 0, 1, 2, 3
|
growth
Time Frame: month 0, 1, 2, 3
|
weight, length, head circumference
|
month 0, 1, 2, 3
|
breastfeeding rates
Time Frame: month 0, 1, 2, 3
|
month 0, 1, 2, 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Yana Emmy E Hoy-Schulz, PhD, Stanford University
- Principal Investigator: Leanne Unicomb, PhD, International Center for Diarrheal Disease Research, Bangladesh
- Study Director: Kaniz Jannat, MBBS, International Center for Diarrheal Disease Research, Bangladesh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Roberts TJ, Hoy-Schulz YE, Jannat K, Parsonnet J. Evidence of inflated exclusive breastfeeding estimates from a clinical trial in Bangladesh. Int Breastfeed J. 2018 Aug 22;13:39. doi: 10.1186/s13006-018-0179-4. eCollection 2018.
- Hoy-Schulz YE, Jannat K, Roberts T, Zaidi SH, Unicomb L, Luby S, Parsonnet J. Safety and acceptability of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 in Bangladeshi infants: a phase I randomized clinical trial. BMC Complement Altern Med. 2016 Feb 2;16:44. doi: 10.1186/s12906-016-1016-1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
July 10, 2013
First Submitted That Met QC Criteria
July 12, 2013
First Posted (Estimate)
July 15, 2013
Study Record Updates
Last Update Posted (Estimate)
October 17, 2016
Last Update Submitted That Met QC Criteria
October 13, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SPO109949
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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