Nutrition, Overgrowth, and Vaccine Efficacy in Low-income... | NCT02745327

Studies
Nutrition, Overgrowth, and Vaccine Efficacy in Low-income Settings

NCT02745327

Sponsor

University of Virginia

Status

Completed

Last Update Posted

May 15, 2019Actual

Enrollment

270Actual

Phase

Not provided

Conditions

Small Intestine Bacterial Overgrowth

Interventions

Not provided

Countries

Bangladesh

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

Apr 15, 2016

First Submission Date that Met QC Criteria

Apr 19, 2016

First Posted Date

Apr 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2019

Last Update Posted Date

May 15, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

William Petri, MD, Division Chief, Infectious Disease, University of VirginiaPrincipal Investigator

Lead Sponsor

University of VirginiaOTHER

Collaborators

Name	Class
Virginia Commonwealth University	OTHER
International Centre for Diarrhoeal Disease Research, Bangladesh	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

270Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

7 Days

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William A Petri, M.D., PhD	University of Virginia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The International Centre for Diarrhoeal Disease Research, Bangladesh		Dhaka			Bangladesh

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34693912	Derived	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.