Microbiota Composition in the Human Small IntestineMICRONCT02351375
MICRO-study: The IntelliCap® System as a Gastrointestinal Fluid Sampling Tool
A study testing diet and IntelliCap® system in people with Microbiota Composition in the Human Small Intestine, run by NIZO Food Research at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Microbiota Composition in the Human Small Intestine
- What is being tested?
- diet and IntelliCap® system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesNetherlands
- Study dates
- Nov 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Age 18-30yrs
- BMI between 20-30 kg/m2
- Regular bowel movement (defecation on average once a day)
- Signed informed consent
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
NIZO food research
Ede, 6718 ZB
Human Nutrition, Wageningen University
Wageningen
About this study
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.
Read the detailed description
The gut microbiota is involved in regulation of host metabolic and immune pathways, and is an important target for dietary interventions. Studies on human microbiota are mainly based on the analysis of fecal samples. The microbiota in the small intestine is at least equally relevant for health as in the large intestine, but the regional composition differs largely. Small intestinal sampling requires invasive procedures. Recently, an electronic medical device, the IntelliCap® system, was developed for the site-specific delivery of drugs in the gastrointestinal tract and patient monitoring. This capsule has been adapted to be used to aspirate liquid from its environment. The IntelliCap® system may offer a minimally-invasive tool for sampling of small intestinal fluid in humans for microbiota analysis.
Objective: To evaluate the IntelliCap® system as a tool to study changes in small intestinal microbiota composition in humans in vivo and its safety and tolerability.
Study design: A randomized cross-over controlled feeding trial in humans will be performed in 10 healthy male volunteers (age 18-30 yr). Two diets are used: a three-day high-protein versus a high-carbohydrate diet, each preceded by a washout diet. These diets target microbiota with fundamentally different fermentation requirements. The IntelliCap® capsule is administered after both intervention periods to collect a fluid sample from the distal small bowel. In parallel, fecal samples are collected. Microbiota composition is analyzed by sequencing using Illumina technology followed by dedicated bioinformatic analysis. Blood samples will be collected and stored to measure metabolic parameters and markers of satiety that can potentially be correlated to the microbiota data.
- Being tested
- diet, IntelliCap® system
- Keywords
- microbiota, small intestine, diet, feces
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietOther
A controlled diet will be provided to participants which consists of either high protein/low carbohydrate, or of low protein/high carbohydrate.
IntelliCap® systemDevice
| Study group | Role | What they receive |
|---|---|---|
| high protein, low carbohydrate | Experimental | a high-protein/low-carbohydrate diet (26,7E% protein, 38.2E% carbohydrate) Receives: Other: diet; Device: IntelliCap® system |
| low protein, high carbohydrate | Experimental | a low-protein/high-carbohydrate diet (7E% protein, 59.6E% carbohydrate) Receives: Other: diet; Device: IntelliCap® system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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)
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).
Measured: At day 3 after commencing either diet 1 or diet 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionJan 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbiota Composition in the Human Small IntestineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- NIZO Food Research
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen University
- Responsible party
- Sponsor
- Investigators
- Els van Hoffen, PhD, Principal investigator, NIZO food research, Ede, The NetherlandsDiederik Esser, PhD, Principal investigator, Human Nutrition, Wageningen University, Wageningen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351375
- Sponsor's protocol ID
- NL50518.081.14
- Acronym
- MICRO
- Status last verified
- Mar 2016
- First submitted
- 21 Jan 2015
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MICRO-study: The IntelliCap® System as a Gastrointestinal Fluid Sampling Tool
- ClinicalTrials.gov ID
- NCT02351375
- Acronym / sponsor ID
- MICRO / NL50518.081.14
- Keywords
- microbiota, small intestine, diet, feces
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NIZO Food ResearchUniversity, hospital or other
- Collaborators
- Wageningen University
- Study start
- Nov 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The gut microbiota is involved in regulation of host metabolic and immune pathways, and is an important target for dietary interventions. Studies on human microbiota are mainly based on the analysis of fecal samples. The microbiota in the small intestine is at least equally relevant for health as in the large intestine, but the regional composition differs largely. Small intestinal sampling requires invasive procedures. Recently, an electronic medical device, the IntelliCap® system, was developed for the site-specific delivery of drugs in the gastrointestinal tract and patient monitoring. This capsule has been adapted to be used to aspirate liquid from its environment. The IntelliCap® system may offer a minimally-invasive tool for sampling of small intestinal fluid in humans for microbiota analysis.
Objective: To evaluate the IntelliCap® system as a tool to study changes in small intestinal microbiota composition in humans in vivo and its safety and tolerability.
Study design: A randomized cross-over controlled feeding trial in humans will be performed in 10 healthy male volunteers (age 18-30 yr). Two diets are used: a three-day high-protein versus a high-carbohydrate diet, each preceded by a washout diet. These diets target microbiota with fundamentally different fermentation requirements. The IntelliCap® capsule is administered after both intervention periods to collect a fluid sample from the distal small bowel. In parallel, fecal samples are collected. Microbiota composition is analyzed by sequencing using Illumina technology followed by dedicated bioinformatic analysis. Blood samples will be collected and stored to measure metabolic parameters and markers of satiety that can potentially be correlated to the microbiota data.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high protein, low carbohydrate | Experimental | Other: diet, Device: IntelliCap® systema high-protein/low-carbohydrate diet (26,7E% protein, 38.2E% carbohydrate) |
| low protein, high carbohydrate | Experimental | Other: diet, Device: IntelliCap® systema low-protein/high-carbohydrate diet (7E% protein, 59.6E% carbohydrate) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males
- Age 18-30yrs
- BMI between 20-30 kg/m2
- Regular bowel movement (defecation on average once a day)
- Signed informed consent
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietA controlled diet will be provided to participants which consists of either high protein/low carbohydrate, or of low protein/high carbohydrate. | Other | high protein, low carbohydrate, low protein, high carbohydrate |
| IntelliCap® system | Device | high protein, low carbohydrate, low protein, high carbohydrate |
Primary outcome
Relative abundance of microbiota species (% of total) in the small intestine
Time frame: 3 days after commencing diet 1 versus 3 days after commensing diet 2
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)
adverse events during passage of IntelliCap® system (capsule) through the gastro-intestinal tract
Time frame: Daily monitoring between ingestion and excretion of the capsule (length of period dependent on transit time of the capsule, expected average 2-3 days)
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).
1 secondary outcome
Relative abundance of microbiota species in the small versus large intestine (feces)
Time frame: At day 3 after commencing either diet 1 or diet 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Els van Hoffen, PhD principal investigator
NIZO food research, Ede, The Netherlands
Diederik Esser, PhD principal investigator
Human Nutrition, Wageningen University, Wageningen, The Netherlands
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet and IntelliCap® system in people with Microbiota Composition in the Human Small Intestine, run by NIZO Food Research at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative abundance of microbiota species (% of total) in the small intestine (time frame: 3 days after commencing diet 1 versus 3 days after commensing diet 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016.