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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

Tracking Information
First Submitted Date  ICMJE July 10, 2013
First Posted Date  ICMJE July 15, 2013
Last Update Posted Date October 17, 2016
Study Start Date  ICMJE October 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2016)
  • Presence of probiotic in the stool [ Time Frame: weeks 0-12 ]
    presence of absence of each probiotic in the stool
  • Adverse events [ Time Frame: duration of study - through study completion ]
    Any adverse or allergic reactions after probiotic administration, hospitalizations, GI and respiratory symptoms
Original Primary Outcome Measures  ICMJE
 (submitted: July 12, 2013)
Presence of probiotic in the stool [ Time Frame: weeks 0-12 ]
presence of absence of each probiotic in the stool
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2013)
  • quantity of probiotic in the stool [ Time Frame: weeks 0-12 ]
    amount of each probiotic present in the stool
  • composition of microbiota [ Time Frame: weeks 0-12 ]
    microbial community composition
  • clinical effects [ Time Frame: daily for 7 days after first probiotic administration, then weeks 2-12 ]
    fever, diarrhea, wheezing, rash, stool frequency, feeding frequency
  • gut function [ Time Frame: months 0, 1, 2, 3 ]
    lactulose/mannitol ratio
  • gut inflammation [ Time Frame: months 0,1,2,3 ]
    fecal neopterin, alpha-1 antitrypsin, and myeloperoxidase - correlated with future growth
  • gut inflammation/translocation [ Time Frame: months 0, 1, 2, 3 ]
    IL22, CD-14, total IgG and c-reactive protein
  • growth [ Time Frame: month 0, 1, 2, 3 ]
    weight, length, head circumference
  • breastfeeding rates [ Time Frame: month 0, 1, 2, 3 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Probiotics in Bangladeshi Infants
Official Title  ICMJE Safety and Efficacy of Probiotics in Bangladeshi Infants
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: daily probiotic
    10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis daily for one month
    Interventions:
    • Dietary Supplement: Lactobacillus reuteri DSM 17938
    • Dietary Supplement: Bifidobacterium longum infantis
  • Experimental: weekly probiotic
    10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis weekly for one month
    Interventions:
    • Dietary Supplement: Lactobacillus reuteri DSM 17938
    • Dietary Supplement: Bifidobacterium longum infantis
  • Experimental: bi-weekly probiotic
    10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis bi-weekly for one month
    Interventions:
    • Dietary Supplement: Lactobacillus reuteri DSM 17938
    • Dietary Supplement: Bifidobacterium longum infantis
  • No Intervention: control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2013)
160
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 3 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01899378
Other Study ID Numbers  ICMJE SPO109949
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Julie Parsonnet, Stanford University
Original Responsible Party Stanford University
Current Study Sponsor  ICMJE Stanford University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • Thrasher Research Fund
Investigators  ICMJE
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
PRS Account Stanford University
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP