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MICRO-study: The IntelliCap® System as a Gastrointestinal Fluid Sampling Tool

NCT02351375 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-03-03

No results posted yet for this study

Summary

This study will explore whether the IntelliCap® system can be used to study the human microbiota composition in the small intestine. The IntelliCap® system is an oral drug delivery and patient monitoring system consisting of a capsule-shaped device and ancillary equipment. The IntelliCap® capsule is also able aspirate fluid from its environment. Here, we explore whether the capsule is able to take a fluid sample from the lumen of the gastrointestinal tract for microbiota analysis. To study this, a controlled dietary intervention that is expected to induce a temporary change in microbiota composition will be performed in healthy volunteers. Microbiota composition of samples collected from the small intestine using the IntelliCap® system will be compared to fecal samples from the same individuals collected at the same time point.

Conditions

  • Microbiota Composition in the Human Small Intestine

Interventions

OTHER

diet

A controlled diet will be provided to participants which consists of either high protein/low carbohydrate, or of low protein/high carbohydrate.

DEVICE

IntelliCap® system

Sponsors & Collaborators

  • Wageningen University

    collaborator OTHER

  • NIZO Food Research

    lead OTHER

Principal Investigators

  • Els van Hoffen, PhD · NIZO food research, Ede, The Netherlands

  • Diederik Esser, PhD · Human Nutrition, Wageningen University, Wageningen, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-01-31
Completion
2015-06-30

Countries

  • Netherlands

Study Locations

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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 NCT02351375 on ClinicalTrials.gov