The International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh
Completed
NCT Number: NCT02745327
Nutrition, Overgrowth, and Vaccine Efficacy in Low-income Settings
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.
Completed
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Conditions
Age range
1 day–7 day
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Glucose-Hydrogen Breath Test
Time frame: Birth to 2 years
Test for Small Intestine Bacterial Overgrowth
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
-
Height
Time frame: Birth to 2 years
-
Weight
Time frame: Birth to 2 years
-
Head circumference
Time frame: Birth to 2 years
Sponsors and collaborators
Lead sponsor
University of Virginia
Other
Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Virginia Commonwealth University
Registry information
Official study title
A Longitudinal Study of Childhood Intestinal Bacterial Overgrowth, Vaccine Underperformance, and Malnutrition
Acronym: NOVEL
Important dates
- Study start
- 2014
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Apr 20, 2016
- Registry last updated
- May 15, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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