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History of Changes for Study: NCT01899378
Safety and Efficacy of Probiotics in Bangledeshi Infants
Latest version (submitted October 13, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 12, 2013 None (earliest Version on record)
2 July 26, 2013 Sponsor/Collaborators and Study Status
3 March 20, 2014 Recruitment Status, Study Status, Oversight, Study Identification, Contacts/Locations, Eligibility and Arms and Interventions
4 November 19, 2014 Recruitment Status, Study Status, Contacts/Locations and Study Design
5 October 13, 2016 Sponsor/Collaborators, Study Status and Outcome Measures
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Study NCT01899378
Submitted Date:  July 12, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: SPO109949
Brief Title: Safety and Efficacy of Probiotics in Bangledeshi Infants
Official Title: Safety and Efficacy of Probiotics in Bangledeshi Infants
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2013
Overall Status: Not yet recruiting
Study Start: July 2013
Primary Completion: December 2013 [Anticipated]
Study Completion: December 2013 [Anticipated]
First Submitted: July 10, 2013
First Submitted that
Met QC Criteria:
July 12, 2013
First Posted: July 15, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 12, 2013
Last Update Posted: July 15, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Stanford University
Responsible Party: Sponsor
Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh
Thrasher Research Foundation
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Healthy
Keywords: probiotics
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 160 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 Names:
  • BioGaia Protectis Baby
Dietary Supplement: Bifidobacterium longum infantis
10^9 CFU
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 Names:
  • BioGaia Protectis Baby
Dietary Supplement: Bifidobacterium longum infantis
10^9 CFU
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 Names:
  • BioGaia Protectis Baby
Dietary Supplement: Bifidobacterium longum infantis
10^9 CFU
No Intervention: control
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Presence of probiotic in the stool
[ Time Frame: weeks 0-12 ]

presence of absence of each probiotic in the stool
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 ]

Open or close this module Eligibility
Minimum Age: 1 Month
Maximum Age: 3 Months
Sex: All
Gender Based:
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 have ever been treated with a course of antibiotics or 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.
Open or close this module Contacts/Locations
Central Contact Person: Yana Emmy Hoy-Schulz, PhD
Telephone: 9129960603
Email: ehoy@stanford.edu
Central Contact Backup: Julie Parsonnet, MD
Email: parsonnt@stanford.edu
Study Officials: Yana Emmy E Hoy-Schulz, PhD
Study Director
Stanford University
Julie Parsonnet, MD
Principal Investigator
Stanford University
Stephen Luby, MD
Principal Investigator
Stanford University
Leanne Unicomb, PhD
Principal Investigator
International Center for Diarrheal Disease Research, Bangladesh
Kaniz Jannat, MBBS
Study Director
International Center for Diarrheal Disease Research, Bangladesh
Locations: Bangladesh
International Center for Diarrheal Disease Research, Bangladesh
Dhaka, Bangladesh
Contact:Contact: Leanne Unicomb, PhD
Contact:Principal Investigator: Leanne Unicomb, PhD
Contact:Sub-Investigator: Kaniz Jannat, MBBS
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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