Nutrition, Overgrowth, and Vaccine Efficacy in Low-income Settings (NOVEL)

A Longitudinal Study of Childhood Intestinal Bacterial Overgrowth, Vaccine Underperformance, and Malnutrition

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.

Study Overview

• Status: Completed
• Conditions: Small Intestine Bacterial Overgrowth

• Study Type: Observational
• Enrollment (Actual): 270

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • The International Centre for Diarrhoeal Disease Research, Bangladesh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Bangladeshi infants from the low-income neighborhood of Mirpur, Dhaka

Description

Inclusion Criteria:

• Child previously enrolled in the FIELD STUDIES protocol (enrollments in both studies may occur simultaneously)
• Mother willing to sign informed consent form.
• Healthy infant aged less than 7 days old

Exclusion Criteria:

• Parents are not willing to have child's blood drawn, oral fluid collected, urine collected, or breath testing performed.
• History of seizures, other apparent neurologic disorders, or other congenital abnormalities involving major organ systems.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose-Hydrogen Breath Test	Test for Small Intestine Bacterial Overgrowth	Birth to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Serum Cobalamin	Birth to 2 years
Serum Albumin	Birth to 2 years
Lactulose mannitol ratio	12 weeks of age
Serum Tetanus antibody titers	Birth to 2 years
Serum Polio antibody titers to sabin strains	Birth to 2 years
Oral fluid Tetanus antibody titers	Birth to 2 years
Height	Birth to 2 years
Weight	Birth to 2 years
Head circumference	Birth to 2 years

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh; Virginia Commonwealth University
• Investigators: Principal Investigator: William A Petri, M.D., PhD, University of Virginia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: April 15, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (Estimate): April 20, 2016

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: nutrition; oral vaccination
• Other Study ID Numbers: PR14083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No