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

NCT02351375 | Completed

• 1 other identifier: NL50518.081.14
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

microbiota; small intestine; diet; feces

Outcome Measures

Primary Outcomes (2)

• Relative abundance of microbiota species (% of total) in the small intestine

  Change in relative abundance of microbiota species (% of total) in the small intestine from day 7 (3 days after commencing diet 1) to day 14 (3 days after commencing diet 2)

  3 days after commencing diet 1 versus 3 days after commensing diet 2

• adverse events during passage of IntelliCap® system (capsule) through the gastro-intestinal tract

  Adverse events during transit of the capsule through the gastrointestinal tract will be registered by short daily questionnaires, until the capsule has been excreted in the feces (in healthy volunteers on average 2-3 days after ingestion).

  Daily monitoring between ingestion and excretion of the capsule (length of period dependent on transit time of the capsule, expected average 2-3 days)

Secondary Outcomes (1)

• Relative abundance of microbiota species in the small versus large intestine (feces)

  At day 3 after commencing either diet 1 or diet 2

Other Outcomes (1)

• Metabolites in blood (and urine if considered relevant)

  At day 3 after commencing either diet 1 or diet 2

Study Arms (2)

high protein, low carbohydrate

EXPERIMENTAL

a high-protein/low-carbohydrate diet (26,7E% protein, 38.2E% carbohydrate)

Other: diet; Device: IntelliCap® system

low protein, high carbohydrate

EXPERIMENTAL

a low-protein/high-carbohydrate diet (7E% protein, 59.6E% carbohydrate)

Other: diet; Device: IntelliCap® system

Interventions

diet OTHER

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

high protein, low carbohydrate; low protein, high carbohydrate

IntelliCap® system DEVICE

high protein, low carbohydrate; low protein, high carbohydrate

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males
• Age 18-30yrs
• BMI between 20-30 kg/m2
• Regular bowel movement (defecation on average once a day)
• Signed informed consent

You may not qualify if:

• History or presence of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study (e.g. diabetes, cardiovascular disease, gastrointestinal disease, renal failure, cancer, infectious disease).
• Presence of swallowing disorder
• Use of any prescribed or non-prescribed medication (other than paracetamol) including antacids, analgesics, and herbal remedies during the three (3) weeks prior to study start.
• Carrying a pacemaker or any other (implanted) medical electronic device
• Scheduled for an MRI scan during the study period
• Tobacco smoker
• Unstable body weight (weight gain or loss \>5kg in the past 3 months)
• Use of antibiotics within 2 months of starting the study or planned during the study
• Use of pro- or prebiotics
• Constipation/infrequent bowel movement
• Abuse of drugs/alcohol (alcohol: \>4 consumptions/day or \>20 consumptions/week)
• Having diarrhea within 2 months prior to the study start
• Vegetarianism/Veganism
• Allergic for dairy products (milk allergy or lactose intolerance)
• Known or suspected allergy to any product used in this study

Sponsors & Collaborators

• NIZO Food Research: lead
• Wageningen University: collaborator

Study Sites (2)

NIZO food research

Ede, 6718 ZB, Netherlands

Location

Human Nutrition, Wageningen University

Wageningen, Netherlands

Location

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Els van Hoffen, PhD

  NIZO food research, Ede, The Netherlands

  PRINCIPAL INVESTIGATOR

• Diederik Esser, PhD

  Human Nutrition, Wageningen University, Wageningen, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: January 30, 2015
• Study Start: November 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 3, 2016

Record last verified: 2016-03

Locations

NL (2)