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

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:
  • BioGaia Protectis Baby
10^9 CFU
Other Names:
  • Align
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:
  • BioGaia Protectis Baby
10^9 CFU
Other Names:
  • Align
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:
  • BioGaia Protectis Baby
10^9 CFU
Other Names:
  • Align

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.

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.

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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