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
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.
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 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 Oral fluid Tetanus antibody titers Birth to 2 years Weight Birth to 2 years Fecal Regenerating Islet-Derived 1 Beta (Reg 1B) Birth to 2 years Lactulose mannitol ratio 12 weeks of age Serum Polio antibody titers to sabin strains Birth to 2 years
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms link SIBO to impaired oral vaccine efficacy in malnourished children?
How does SIBO-associated dysbiosis compare to standard-of-care nutritional interventions in low-income settings?
Which biomarkers correlate with SIBO severity and growth outcomes in NCT02745327 University of Virginia study?
What adverse events are associated with SIBO management in pediatric populations, and how are they mitigated?
Are probiotics or prebiotics effective as adjuncts to SIBO treatment in improving vaccine responses and nutrition?
Trial Locations
- Locations (1)
The International Centre for Diarrhoeal Disease Research, Bangladesh
🇧🇩Dhaka, Bangladesh
The International Centre for Diarrhoeal Disease Research, Bangladesh🇧🇩Dhaka, Bangladesh