Trials / Terminated
TerminatedNCT03075228
Comparison of the Microbial Composition in Lean and Obese Subjects
DUPLO Study: Comparison of the Microbial Composition of the Upper Gastrointestinal Tract in Lean and Obese Subjects
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 10 (actual)
- Sponsor
- NIZO Food Research · Academic / Other
- Sex
- Female
- Age
- 25 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
Rationale: The microbial composition in the small intestine (SI) differs largely from the composition in feces. Many physiological processes related to health, such as immunoregulation and metabolic programming, mainly take place in the SI. Therefore, the SI, from a microbiota perspective, is as relevant as the large intestine. There are indications that microbiota composition is different in lean and obese subjects, and is related to insulin resistance. However, these indications are mainly based on the analysis of fecal samples. Therefore, analysis of the microbiota composition in the more proximal part of the gastrointestinal (GI) tract may provide new insights into the microbial species that are involved or related to metabolic homeostasis at that location. The IntelliCap® CR system offers a minimally invasive tool that is able to collect reliable samples in the SI, as was shown by NIZO in a clinical validation study. The main aim of the current study is to explore and compare the upper GI microbiota composition in lean and obese subjects, in order to generate new leads for development of products that may target the upper GI microbiota community or specific species thereof, which may impact the maintenance of metabolic homeostasis. This may provide new opportunities for the treatment, reduction or prevention of overweight and/or obesity or insulin resistance.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IntelliCap | Sampling of the small intestine using a samling capsule. |
Timeline
- Start date
- 2017-04-25
- Primary completion
- 2017-07-04
- Completion
- 2017-07-04
- First posted
- 2017-03-09
- Last updated
- 2017-07-14
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT03075228. Inclusion in this directory is not an endorsement.