NCT02745327

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

4.1 years

First QC Date

April 15, 2016

Last Update Submit

May 13, 2019

Conditions

Small Intestine Bacterial Overgrowth

Keywords

oral vaccinationnutrition

Outcome Measures

Primary Outcomes (1)

  • Glucose-Hydrogen Breath Test

    Test for Small Intestine Bacterial Overgrowth

    Birth to 2 years

Secondary Outcomes (14)

  • 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

  • +9 more secondary outcomes

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Location

Related Publications (1)

  • 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.

    PMID: 34693912DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, and urine.

Study Officials

  • William A Petri, M.D., PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Chief, Infectious Disease

Study Record Dates

First Submitted

April 15, 2016

First Posted

April 20, 2016

Study Start

November 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 15, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)