Clinical trial NCT01899378: Safety and Efficacy of Probiotics in Bangladeshi Infants
Official title: Safety and Efficacy of Probiotics in Bangladeshi Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: probiotics
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Thrasher Research Fund
First posted: 2013-07-15
Enrollment: 160
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Presence of probiotic in the stool
timeFrame: weeks 0-12
measure: Adverse events
timeFrame: duration of study - through study completion
Secondary outcomes:
measure: quantity of probiotic in the stool
timeFrame: weeks 0-12
measure: composition of microbiota
timeFrame: weeks 0-12
measure: clinical effects
timeFrame: daily for 7 days after first probiotic administration, then weeks 2-12
measure: gut function
timeFrame: months 0, 1, 2, 3
measure: gut inflammation
timeFrame: months 0,1,2,3
measure: gut inflammation/translocation
timeFrame: months 0, 1, 2, 3
measure: growth
timeFrame: month 0, 1, 2, 3
measure: breastfeeding rates
timeFrame: month 0, 1, 2, 3
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Center for Diarrheal Disease Research, Bangladesh
Study officials:
affiliation: Stanford University
name: Yana Emmy E Hoy-Schulz, PhD
role: STUDY_DIRECTOR
affiliation: Stanford University
name: Julie Parsonnet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Stephen Luby, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Center for Diarrheal Disease Research, Bangladesh
name: Leanne Unicomb, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Center for Diarrheal Disease Research, Bangladesh
name: Kaniz Jannat, MBBS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.