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

University of Virginia270 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

270

Conditions

Small Intestine Bacterial Overgrowth

Eligibility

Sex: ALLMin age: 1 DayMax age: 7 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Outcomes

Primary Outcomes

Glucose-Hydrogen Breath Test

Test for Small Intestine Bacterial Overgrowth

Time frame: Birth to 2 years

Secondary Outcomes

Fecal Regenerating Islet-Derived 1 Beta (Reg 1B)

Time frame: Birth to 2 years

Fecal Myeloperoxidase

Time frame: Birth to 2 years

Serum 25-OH vitamin D

Time frame: Birth to 2 years

Serum Zinc

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 Albumin

Time frame: Birth to 2 years

Lactulose mannitol ratio

Time frame: 12 weeks of age

Serum Tetanus antibody titers

Time frame: Birth to 2 years

Serum Polio antibody titers to sabin strains

Time frame: Birth to 2 years

Oral fluid Tetanus antibody titers

Time frame: Birth to 2 years

Data from ClinicalTrials.gov

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