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NCT03751137 · ClinicalTrials.gov registry record
GI Tract Biomarkers in Infants With Different Diets
A clinical trial, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- 34
- Enrollment target
NCT03751137 is a clinical trial that has completed, run by Nemours Children's Clinic. The registered enrollment target is 34 participants.
The verdict
NCT03751137 has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- 34 participants
- Enrollment target
Study Summary
Childhood obesity is increasing with more than one-third of adolescents currently overweight and one in five with obesity. The lifelong incidence of obesity-related morbidities is also increasing with childhood obesity. It is not yet known how obesity develops in an individual, specifically in early childhood. Further, it is unclear what mechanistic role a child's earliest nutrition or changing intestinal flora has in the etiology of obesity. Very young children are developing appetite and satiety patterns early in life. Nutrition and gut microbial flora have impact on how these processes unfold, but specific mechanisms are not yet well understood. The investigators hypothesize that formula-fed infants with changes in their microbial flora are more likely to have altered carbohydrate metabolism, evidenced by greater imbalances of fatty acid production, and are more likely to have accelerated growth trajectory due to satiety disruption. The investigators further hypothesize that altered carbohydrate metabolism, e.g. imbalances of short- and long-chain fatty acid levels in the gut, stimulate cellular stress and affect specific gut hormones. This study will compare the microbiome of the intestinal microbial flora in two groups of infants, one breast fed and the other formula fed, using longitudinally collected fecal samples from both groups. Samples will be subjected to shotgun metagenomic analysis and simultaneous metabolomic analysis. A bioinformatics approach will elucidate key differences among and between sample groups, and will further analyze bacterial gene expression levels related to carbohydrate metabolism. This study will compare the expression of human proteins involved in cellular stress response and gut peptide signaling by applying quantitative Reverse Transcriptase-Polymerase Chain Reaction to human messenger RNA isolated from the longitudinally collected samples from both groups. Finally, this study will monitor the trajectory of growth and feeding ove
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2016-03-10 |
| Est. Completion | 2025-05-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03751137
The ClinicalTrials.gov registry entry for NCT03751137 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT03751137 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03751137 about?
NCT03751137 is a clinical study titled "GI Tract Biomarkers in Infants With Different Diets". Childhood obesity is increasing with more than one-third of adolescents currently overweight and one in five with obesity. The lifelong incidence of obesity-related morbidities is also increasing with childhood obesity. It is not yet known how obesity develops in an individual, specifically in early...
What is the current status of trial NCT03751137?
This trial is currently completed. The enrollment target is 34 participants. The study started on 2016-03-10. Estimated completion is 2025-05-30.
Who is sponsoring clinical trial NCT03751137?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
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