The primary objective is to evaluate the safety and tolerability of the IntelliCap® system when used as a gastrointestinal fluid sampling device will be evaluated.Another primary aim is to evaluate the IntelliCap® system as a tool to study changes…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Effect of diet on microbiota composition in the small intestine
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety and tolerability of the IntelliCap® system when used as a
gastrointestinal fluid sampling device, as assessed by reporting adverse events
(AE) and serious adverse events (SAEs) that occur during the study along with
their severity and potential relationship to the IntelliCap® system.
Small intestinal microbiota composition after the 2 dietary intervention
periods, analysed by 16S pyrosequencing.
Secondary outcome
Small intestinal microbiota composition as compared to the faecal microbiota
composition, analysed by 16S pyrosequencing.
Background summary
The gut microbiota is involved in the regulation of multiple host metabolic and
immune pathways. So far, studies on human microbiota are almost exclusively
based on the analysis of fecal samples. Short-term exposure to extreme diets
(high protein versus high carbohydrate) can induce rapid changes in fecal
microbiota. However, the microbiota in the small intestine is as relevant for
health as in the large intestine. Recently, an electronic medical device, named
the IntelliCap® system, was developed for the site-specific delivery of drugs
in the gastrointestinal tract. The CE certified IntelliCap® system comprises a
capsule-shaped delivery device (IntelliCap® capsule) and ancillary equipment.
The IntelliCap® capsule transmits measured data wirelessly to a computer, which
enables the real-time measurement of pH and body temperature, allowing for
minimally-invasive detection of its location in the gastrointestinal tract. By
reversing the delivery mechanism of the device, this capsule has been used to
aspirate liquid from its environment. The IntelliCap® system may thus be used
as a minimally-invasive tool for the sampling of small intestinal microbiota in
humans.
Study objective
The primary objective is to evaluate the safety and tolerability of the
IntelliCap® system when used as a gastrointestinal fluid sampling device will
be evaluated.
Another primary aim is to evaluate the IntelliCap® system as a tool to study
changes in small intestinal microbiota composition in humans in vivo. We will
do this by studying the impact of a high protein or high carbohydrate diet on
microbial composition in the small intestine.
Secondary objective is to compare the faecal microbial composition to the
microbial composition in the small intestine.
Study design
Randomized cross-over controlled feeding trial. Two diets will be used: a
high-protein diet versus a high-carbohydrate diet given for three days.
Volunteers will also receive a three day medium protein/medium carbohydrate
before (run-in diet) and in between the intervention diets (wash-out diet). The
IntelliCap® capsule will be administered at the end of both intervention
periods. In short: after an overnight fast, subjects will ingest the
IntelliCap® capsule with water. Subjects will receive a breakfast after the
passage of the capsule from the stomach to the duodenum (around 30 to 60 min;
based on on-line measurement of change in pH). A luminal sample will be taken
in the small intestine when the capsule reaches the ileum (around ~3h; based on
on-line measurement of change in pH). After ingestion, subjects need to collect
all faeces until excretion and recovery of the capsule (around 24-48 h after
swallowing). Participants will report any adverse events to the study team.
Intervention
A high-protein/low-carbohydrate diet (26,7E% protein, 38.2E% carbohydrate), a
low-protein/high-carbohydrate diet (7E% protein, 59.6E% carbohydrate).
Study burden and risks
Subjects that participate in this study will invest approximately 20 hours.
There are minor risks for the participants during the study. There is no
evidence that the controlled diets in the intervention are unsafe. All foods
and drinks provided are commercially available and composed by professional
dieticians of Wageningen University. The CE certified IntelliCap® system,
regularly used in humans for the targeted delivery of substances (drugs), is
safe and well tolerated. If the IntelliCap® capsule is not recovered from the
faeces within 7 days after administration, an abdominal X-ray will be performed
to check if the IntelliCap® capsule is still within the body. Participants will
receive ¤200,- for completing the study. Subjects will also receive a repayment
of traveling expenditures, with a total maximum of ¤50,-. If reserve
participants do not need to replace dropouts, they will receive ¤75,- plus a
maximum of ¤25,- travel expenditure repayment for their participation.
Furthermore all foods and drinks for 14 days during the intervention trial will
be provided for.
Kernhemseweg 2
Ede 6718 ZB
NL
Kernhemseweg 2
Ede 6718 ZB
NL
Listed location countries
Age
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)
• Participation in another biomedical study
• Having diarrhoea 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
• Personnel of Wageningen University, Division of Human Nutrition.
• Current participation in other research from the Division of Human Nutrition
• Not willing to have an X-ray if the capsule is not recovered from the faeces
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50518.081.14 |