Nutrition, Overgrowth, and Vaccine Efficacy in Low-income Settings
Completed
- Conditions
- Small Intestine Bacterial Overgrowth
- Registration Number
- NCT02745327
- Lead Sponsor
- University of Virginia
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
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
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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.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glucose-Hydrogen Breath Test Birth to 2 years Test for Small Intestine Bacterial Overgrowth
- Secondary Outcome Measures
Name Time Method Lactulose mannitol ratio 12 weeks of age Serum Polio antibody titers to sabin strains Birth to 2 years Oral fluid Tetanus antibody titers Birth to 2 years Fecal Myeloperoxidase Birth to 2 years Serum Cobalamin Birth to 2 years Serum Albumin Birth to 2 years Serum Tetanus antibody titers Birth to 2 years Height Birth to 2 years Head circumference 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 Weight Birth to 2 years Fecal Regenerating Islet-Derived 1 Beta (Reg 1B) Birth to 2 years
Trial Locations
- Locations (1)
The International Centre for Diarrhoeal Disease Research, Bangladesh
🇧🇩Dhaka, Bangladesh