Small Intestine Bacterial Overgrowth Clinical Trial
— NOVELOfficial title:
A Longitudinal Study of Childhood Intestinal Bacterial Overgrowth, Vaccine Underperformance, and Malnutrition
| NCT number | NCT02745327 |
| Other study ID # | PR14083 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 2014 |
| Est. completion date | December 2018 |
| Verified date | May 2019 |
| Source | University of Virginia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 270 |
| Est. completion date | December 2018 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A to 7 Days |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Bangladesh | The International Centre for Diarrhoeal Disease Research, Bangladesh | Dhaka |
| Lead Sponsor | Collaborator |
|---|---|
| University of Virginia | International Centre for Diarrhoeal Disease Research, Bangladesh, Virginia Commonwealth University |
Bangladesh,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Glucose-Hydrogen Breath Test | Test for Small Intestine Bacterial Overgrowth | Birth to 2 years | |
| Secondary | Fecal Regenerating Islet-Derived 1 Beta (Reg 1B) | Birth to 2 years | ||
| Secondary | Fecal Myeloperoxidase | Birth to 2 years | ||
| Secondary | Serum 25-OH vitamin D | Birth to 2 years | ||
| Secondary | Serum Zinc | Birth to 2 years | ||
| Secondary | Serum Retinol Binding Protein | Birth to 2 years | ||
| Secondary | Serum Cobalamin | Birth to 2 years | ||
| Secondary | Serum Albumin | Birth to 2 years | ||
| Secondary | Lactulose mannitol ratio | 12 weeks of age | ||
| Secondary | Serum Tetanus antibody titers | Birth to 2 years | ||
| Secondary | Serum Polio antibody titers to sabin strains | Birth to 2 years | ||
| Secondary | Oral fluid Tetanus antibody titers | Birth to 2 years | ||
| Secondary | Height | Birth to 2 years | ||
| Secondary | Weight | Birth to 2 years | ||
| Secondary | Head circumference | Birth to 2 years |