Safety and Efficacy of Probiotics in Bangladeshi Infants
1 other identifier
interventional
160
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Oct 2013
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2013
CompletedFirst Posted
Study publicly available on registry
July 15, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedOctober 17, 2016
April 1, 2016
9 months
July 10, 2013
October 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Presence of probiotic in the stool
presence of absence of each probiotic in the stool
weeks 0-12
Adverse events
Any adverse or allergic reactions after probiotic administration, hospitalizations, GI and respiratory symptoms
duration of study - through study completion
Secondary Outcomes (8)
quantity of probiotic in the stool
weeks 0-12
composition of microbiota
weeks 0-12
clinical effects
daily for 7 days after first probiotic administration, then weeks 2-12
gut function
months 0, 1, 2, 3
gut inflammation
months 0,1,2,3
- +3 more secondary outcomes
Study Arms (4)
daily probiotic
EXPERIMENTAL10\^8 CFU Lactobacillus reuteri DSM 17938 and 10\^9 Bifidobacterium longum infantis daily for one month
weekly probiotic
EXPERIMENTAL10\^8 CFU Lactobacillus reuteri DSM 17938 and 10\^9 Bifidobacterium longum infantis weekly for one month
bi-weekly probiotic
EXPERIMENTAL10\^8 CFU Lactobacillus reuteri DSM 17938 and 10\^9 Bifidobacterium longum infantis bi-weekly for one month
control
NO INTERVENTIONInterventions
10\^8 CFU
10\^9 CFU
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- International Centre for Diarrhoeal Disease Research, Bangladeshcollaborator
- Thrasher Research Fundcollaborator
Study Sites (1)
International Center for Diarrheal Disease Research, Bangladesh
Dhaka, Bangladesh
Related Publications (2)
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.
PMID: 30159001DERIVEDHoy-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.
PMID: 26832746DERIVED
Study Officials
- STUDY DIRECTOR
Yana Emmy E Hoy-Schulz, PhD
Stanford University
- PRINCIPAL INVESTIGATOR
Julie Parsonnet, MD
Stanford University
- PRINCIPAL INVESTIGATOR
Stephen Luby, MD
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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 10, 2013
First Posted
July 15, 2013
Study Start
October 1, 2013
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
October 17, 2016
Record last verified: 2016-04