NCT02745327|Completed
Nutrition, Overgrowth, and Vaccine Efficacy in Low-income Settings
NOVEL
A Longitudinal Study of Childhood Intestinal Bacterial Overgrowth, Vaccine Underperformance, and Malnutrition
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NOVEL
A Longitudinal Study of Childhood Intestinal Bacterial Overgrowth, Vaccine Underperformance, and Malnutrition
Sponsor study identifier
observational
270
1 country
1
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2018
Actual (reported)Study Completion
December 2018
Actual (reported)The purpose of this study is to assess the impact of small intestine bacterial overgrowth (SIBO) on childhood nutritional status, growth, and oral vaccine efficacy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
April 15, 2016
Actual (reported)April 20, 2016
Actual (reported)December 2018
Actual (reported)December 2018
Actual (reported)Glucose-Hydrogen Breath Test
Test for Small Intestine Bacterial Overgrowth
Birth to 2 years
Fecal Regenerating Islet-Derived 1 Beta (Reg 1B)
Birth to 2 years
Fecal Myeloperoxidase
Birth to 2 years
Serum 25-OH vitamin D
Birth to 2 years
Serum Zinc
Birth to 2 years
Serum Retinol Binding Protein
Birth to 2 years
Bangladeshi infants from the low-income neighborhood of Mirpur, Dhaka
The International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh
Donowitz JR, Pu Z, Lin Y, Alam M, Ferdous T, Shama T, Taniuchi M, Islam MO, Kabir M, Nayak U, Faruque ASG, Haque R, Ma JZ, Petri WA Jr. Small Intestine Bacterial Overgrowth in Bangladeshi Infants Is Associated With Growth Stunting in a Longitudinal Cohort. Am J Gastroenterol. 2022 Jan 1;117(1):167-175. doi: 10.14309/ajg.0000000000001535.
Blood, stool, and urine.
William A Petri, M.D., PhD
University of Virginia
270 participants (actual enrollment reported by the registry).
First Submitted
April 15, 2016
First Posted
April 20, 2016
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2018
Actual (reported)Study Completion
December 2018
Actual (reported)Last Updated
May 15, 2019
Record last verified: 2019-05
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.
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