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

A Longitudinal Study of Childhood Intestinal Bacterial Overgrowth, Vaccine Underperformance, and Malnutrition

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02745327
Acronym
NOVEL
Enrollment
270
Registered
2016-04-20
Start date
2014-11-30
Completion date
2018-12-31
Last updated
2019-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Intestine Bacterial Overgrowth

Keywords

oral vaccination, nutrition

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.

Interventions

None listed

Sponsors

Virginia Commonwealth University
CollaboratorOTHER
International Centre for Diarrhoeal Disease Research, Bangladesh
CollaboratorOTHER
University of Virginia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 7 Days
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Glucose-Hydrogen Breath TestBirth to 2 yearsTest for Small Intestine Bacterial Overgrowth

Secondary

MeasureTime frame
Fecal MyeloperoxidaseBirth to 2 years
Serum 25-OH vitamin DBirth to 2 years
Serum ZincBirth to 2 years
Serum Retinol Binding ProteinBirth to 2 years
Serum CobalaminBirth to 2 years
Serum AlbuminBirth to 2 years
Fecal Regenerating Islet-Derived 1 Beta (Reg 1B)Birth to 2 years
Serum Tetanus antibody titersBirth to 2 years
Serum Polio antibody titers to sabin strainsBirth to 2 years
Oral fluid Tetanus antibody titersBirth to 2 years
HeightBirth to 2 years
WeightBirth to 2 years
Head circumferenceBirth to 2 years
Lactulose mannitol ratio12 weeks of age

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026