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

NCT ID: NCT02745327

Last Updated: 2019-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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Small Intestine Bacterial Overgrowth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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William Petri, MD

Division Chief, Infectious Disease

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William A Petri, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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The International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, , Bangladesh

Site Status

Countries

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Bangladesh

References

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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.

Reference Type DERIVED
PMID: 34693912 (View on PubMed)

Other Identifiers

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PR14083

Identifier Type: -

Identifier Source: org_study_id

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