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Safety and Efficacy of Probiotics in Bangladeshi Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01899378
Recruitment Status : Completed
First Posted : July 15, 2013
Last Update Posted : October 17, 2016
Sponsor:
Collaborators:
International Centre for Diarrhoeal Disease Research, Bangladesh
Thrasher Research Fund
Information provided by (Responsible Party):
Julie Parsonnet, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Lactobacillus reuteri DSM 17938 Dietary Supplement: Bifidobacterium longum infantis Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Safety and Efficacy of Probiotics in Bangladeshi Infants
Study Start Date : October 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: daily probiotic
10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis daily for one month
 Dietary Supplement: Lactobacillus reuteri DSM 17938
10^8 CFU
Other Name: BioGaia Protectis Baby

Dietary Supplement: Bifidobacterium longum infantis
10^9 CFU
Other Name: Align
Experimental: weekly probiotic
10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis weekly for one month
 Dietary Supplement: Lactobacillus reuteri DSM 17938
10^8 CFU
Other Name: BioGaia Protectis Baby

Dietary Supplement: Bifidobacterium longum infantis
10^9 CFU
Other Name: Align
Experimental: bi-weekly probiotic
10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis bi-weekly for one month
 Dietary Supplement: Lactobacillus reuteri DSM 17938
10^8 CFU
Other Name: BioGaia Protectis Baby

Dietary Supplement: Bifidobacterium longum infantis
10^9 CFU
Other Name: Align
No Intervention: control


Outcome Measures
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Primary Outcome Measures :
  1. Presence of probiotic in the stool [ Time Frame: weeks 0-12 ]
    presence of absence of each probiotic in the stool

  2. Adverse events [ Time Frame: duration of study - through study completion ]
    Any adverse or allergic reactions after probiotic administration, hospitalizations, GI and respiratory symptoms


Secondary Outcome Measures :
  1. quantity of probiotic in the stool [ Time Frame: weeks 0-12 ]
    amount of each probiotic present in the stool

  2. composition of microbiota [ Time Frame: weeks 0-12 ]
    microbial community composition

  3. clinical effects [ Time Frame: daily for 7 days after first probiotic administration, then weeks 2-12 ]
    fever, diarrhea, wheezing, rash, stool frequency, feeding frequency

  4. gut function [ Time Frame: months 0, 1, 2, 3 ]
    lactulose/mannitol ratio

  5. gut inflammation [ Time Frame: months 0,1,2,3 ]
    fecal neopterin, alpha-1 antitrypsin, and myeloperoxidase - correlated with future growth

  6. gut inflammation/translocation [ Time Frame: months 0, 1, 2, 3 ]
    IL22, CD-14, total IgG and c-reactive protein

  7. growth [ Time Frame: month 0, 1, 2, 3 ]
    weight, length, head circumference

  8. breastfeeding rates [ Time Frame: month 0, 1, 2, 3 ]

Eligibility Criteria
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Ages Eligible for Study:   1 Month to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899378


Locations
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Bangladesh
International Center for Diarrheal Disease Research, Bangladesh
Dhaka, Bangladesh
Sponsors and Collaborators
Stanford University
International Centre for Diarrhoeal Disease Research, Bangladesh
Thrasher Research Fund
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Julie Parsonnet, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01899378    
Other Study ID Numbers: SPO109949
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: April 2016
Keywords provided by Julie Parsonnet, Stanford University:
probiotics