Microbiota Composition in the Human Small Intestine Clinical Trial
— MICROOfficial title:
MICRO-study: The IntelliCap® System as a Gastrointestinal Fluid Sampling Tool
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | June 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 30 Years |
| Eligibility |
Inclusion Criteria: - Healthy males - Age 18-30yrs - BMI between 20-30 kg/m2 - Regular bowel movement (defecation on average once a day) - Signed informed consent Exclusion Criteria: - 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 - Not willing to have an X-ray if the capsule is not recovered from the faeces - Personnel of Wageningen University, Division of Human Nutrition. - Current participation in other research from the Division of Human Nutrition - Participation in another biomedical study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | NIZO food research | Ede | |
| Netherlands | Human Nutrition, Wageningen University | Wageningen |
| Lead Sponsor | Collaborator |
|---|---|
| NIZO Food Research | Wageningen University |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Metabolites in blood (and urine if considered relevant) | Explorative: difference in serum level (and urine level if considered relevant) of metabolites (e.g. short chain fatty acids and bile acids) that can potentially be correlated to the microbiota data. The difference in levels between day 7 (3 days after commencing diet 1) and day 14 (3 days after commencing diet 2) will be analyzed. | At day 3 after commencing either diet 1 or diet 2 | No |
| Primary | 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 | No |
| Primary | 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) | Yes |
| Secondary | Relative abundance of microbiota species in the small versus large intestine (feces) | Difference in relative abundance of microbiota species (% of total) between small and large intestine (feces) at day 7 (3 days after commencing diet 1) and at day 14 (3 days after commencing diet 2). | At day 3 after commencing either diet 1 or diet 2 | No |