Safety and Efficacy of Probiotics in Bangladeshi Infants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Lactobacillus reuteri DSM 17938; Dietary Supplement: Bifidobacterium longum infantis

• Registration Number: NCT01899378
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-07-12
• Study First Posted: 2013-07-15
• Study Start: 2013-10
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-04
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
daily probiotic	Bifidobacterium longum infantis	10\^8 CFU Lactobacillus reuteri DSM 17938 and 10\^9 Bifidobacterium longum infantis daily for one month
daily probiotic	Lactobacillus reuteri DSM 17938	10\^8 CFU Lactobacillus reuteri DSM 17938 and 10\^9 Bifidobacterium longum infantis daily for one month
weekly probiotic	Lactobacillus reuteri DSM 17938	10\^8 CFU Lactobacillus reuteri DSM 17938 and 10\^9 Bifidobacterium longum infantis weekly for one month
bi-weekly probiotic	Lactobacillus reuteri DSM 17938	10\^8 CFU Lactobacillus reuteri DSM 17938 and 10\^9 Bifidobacterium longum infantis bi-weekly for one month
bi-weekly probiotic	Bifidobacterium longum infantis	10\^8 CFU Lactobacillus reuteri DSM 17938 and 10\^9 Bifidobacterium longum infantis bi-weekly for one month
weekly probiotic	Bifidobacterium longum infantis	10\^8 CFU Lactobacillus reuteri DSM 17938 and 10\^9 Bifidobacterium longum infantis weekly for one month

Primary Outcome Measures

Name	Time	Method
Presence of probiotic in the stool	weeks 0-12	presence of absence of each probiotic in the stool
Adverse events	duration of study - through study completion	Any adverse or allergic reactions after probiotic administration, hospitalizations, GI and respiratory symptoms

Secondary Outcome Measures

Name	Time	Method
growth	month 0, 1, 2, 3	weight, length, head circumference
composition of microbiota	weeks 0-12	microbial community composition
gut function	months 0, 1, 2, 3	lactulose/mannitol ratio
quantity of probiotic in the stool	weeks 0-12	amount of each probiotic present in the stool
clinical effects	daily for 7 days after first probiotic administration, then weeks 2-12	fever, diarrhea, wheezing, rash, stool frequency, feeding frequency
gut inflammation/translocation	months 0, 1, 2, 3	IL22, CD-14, total IgG and c-reactive protein
breastfeeding rates	month 0, 1, 2, 3
gut inflammation	months 0,1,2,3	fecal neopterin, alpha-1 antitrypsin, and myeloperoxidase - correlated with future growth

Trial Locations

Locations (1)

International Center for Diarrheal Disease Research, Bangladesh; 🇧🇩 Dhaka, Bangladesh