Comparison of the Microbial Composition in Lean and Obese Subjects

NCT03075228 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2017-07-14

No results posted yet for this study

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

DEVICE

IntelliCap

Sampling of the small intestine using a samling capsule.

Sponsors & Collaborators

  • Danisco Sweeteners Oy

    collaborator INDUSTRY
  • NIZO Food Research

    lead OTHER

Principal Investigators

  • Els van Hoffen, PhD · NIZO food research BV

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-25
Primary Completion
2017-07-04
Completion
2017-07-04

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03075228 on ClinicalTrials.gov