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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02745327
Date of registration:	15/04/2016
Prospective Registration:	No
Primary sponsor:	University of Virginia
Public title:	Nutrition, Overgrowth, and Vaccine Efficacy in Low-income Settings NOVEL
Scientific title:	A Longitudinal Study of Childhood Intestinal Bacterial Overgrowth, Vaccine Underperformance, and Malnutrition
Date of first enrolment:	November 2014
Target sample size:	270
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02745327
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Bangladesh

Contacts

Name:	William A Petri, M.D., PhD
Address:
Telephone:
Email:
Affiliation:	University of Virginia

Key inclusion & exclusion 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.

Age minimum: N/A
Age maximum: 7 Days
Gender: All

Health Condition(s) or Problem(s) studied

Small Intestine Bacterial Overgrowth

Intervention(s)

Primary Outcome(s)

Glucose-Hydrogen Breath Test [Time Frame: Birth to 2 years]

Secondary Outcome(s)

Serum Tetanus antibody titers [Time Frame: Birth to 2 years]

Fecal Myeloperoxidase [Time Frame: Birth to 2 years]

Fecal Regenerating Islet-Derived 1 Beta (Reg 1B) [Time Frame: Birth to 2 years]

Head circumference [Time Frame: Birth to 2 years]

Height [Time Frame: Birth to 2 years]

Oral fluid Tetanus antibody titers [Time Frame: Birth to 2 years]

Serum 25-OH vitamin D [Time Frame: Birth to 2 years]

Serum Polio antibody titers to sabin strains [Time Frame: Birth to 2 years]

Weight [Time Frame: Birth to 2 years]

Lactulose mannitol ratio [Time Frame: 12 weeks of age]

Serum Albumin [Time Frame: Birth to 2 years]

Serum Retinol Binding Protein [Time Frame: Birth to 2 years]

Serum Cobalamin [Time Frame: Birth to 2 years]

Serum Zinc [Time Frame: Birth to 2 years]

Secondary ID(s)

PR14083

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

International Centre for Diarrhoeal Disease Research, Bangladesh

Virginia Commonwealth University

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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