NCT01899378|CompletedPhase 1DMC
Loading search results
Sponsor study identifier
interventional
160
1 country
1
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2014
Actual (reported)Study Completion
July 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 10, 2013
Actual (reported)July 15, 2013
Actual (reported)October 2013
Date type not reportedThis date has not been verified as actual or estimated.
July 2014
Actual (reported)July 2014
Actual (reported)Presence of probiotic in the stool
presence of absence of each probiotic in the stool
weeks 0-12
Adverse events
Any adverse or allergic reactions after probiotic administration, hospitalizations, GI and respiratory symptoms
duration of study - through study completion
quantity of probiotic in the stool
weeks 0-12
composition of microbiota
weeks 0-12
clinical effects
daily for 7 days after first probiotic administration, then weeks 2-12
gut function
months 0, 1, 2, 3
gut inflammation
months 0,1,2,3
10\^8 CFU Lactobacillus reuteri DSM 17938 and 10\^9 Bifidobacterium longum infantis daily for one month
10\^8 CFU Lactobacillus reuteri DSM 17938 and 10\^9 Bifidobacterium longum infantis weekly for one month
10\^8 CFU
International Center for Diarrheal Disease Research, Bangladesh
Dhaka, Bangladesh
Roberts TJ, Hoy-Schulz YE, Jannat K, Parsonnet J. Evidence of inflated exclusive breastfeeding estimates from a clinical trial in Bangladesh. Int Breastfeed J. 2018 Aug 22;13:39. doi: 10.1186/s13006-018-0179-4. eCollection 2018.
Hoy-Schulz YE, Jannat K, Roberts T, Zaidi SH, Unicomb L, Luby S, Parsonnet J. Safety and acceptability of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 in Bangladeshi infants: a phase I randomized clinical trial. BMC Complement Altern Med. 2016 Feb 2;16:44. doi: 10.1186/s12906-016-1016-1.
Yana Emmy E Hoy-Schulz, PhD
Stanford University
Julie Parsonnet, MD
Stanford University
Stephen Luby, MD
Stanford University
Leanne Unicomb, PhD
International Center for Diarrheal Disease Research, Bangladesh
160 participants (actual enrollment reported by the registry).
First Submitted
July 10, 2013
First Posted
July 15, 2013
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
CC100: Safety and Tolerability of Single Doses
10\^8 CFU Lactobacillus reuteri DSM 17938 and 10\^9 Bifidobacterium longum infantis bi-weekly for one month
10\^9 CFU
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Kaniz Jannat, MBBS
International Center for Diarrheal Disease Research, Bangladesh
Primary Completion
July 2014
Actual (reported)Study Completion
July 2014
Actual (reported)Last Updated
October 17, 2016
Record last verified: 2016-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: