Systemic AvailabilitySistineNCT06082726
The Systemic Concentration of Short-Chain Fatty Acids After Delivery in the Small and Large Intestine of Healthy Volunteers
A study testing SCFA in people with Systemic Availability and Intestinal Absorption, run by KU Leuven at 1 site in Belgium.
Trial summary
The goal of this crossover study is to evaluate the systemic availability of short-chain fatty acids (SCFA) that are either administered in the small intestine or the colon in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Availability, Intestinal Absorption, Metabolism
- What is being tested?
- SCFA
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Oct 2023to 11 Mar 2024
- Phase
- Interventional
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- female and male
- healthy participants
- age within 18 - 50 years
- normal BMI (18.5-25 kg/m^2)
Who cannot join
- Chronic gastrointestinal disorders such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), celiac disease, chronic constipation (less than 3 stools a week) and chronic frequent diarrhoea (more than 3 stools a day)
- Previous abdominal surgery, except from appendectomy
- Being on a weight loss, gluten-free, lactose-free, or vegan diet
- The donation of blood during the last 3 months or suffering from low blood haemoglobin levels
- The use of antibiotics or other medication that affects the gastrointestinal tract 3 months preceding the study and/or during the study
- The use of prebiotics or probiotics 2 weeks preceding the study and/or during the study
- Pregnancy, lactation or wish to become pregnant during the study period
- Previous or current substance/alcohol dependence or abuse (> 2 units per day/14 units per week)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Systemic Availability of Short-Chain Fatty Acids After Delivery in the Small Intestine and the Colon
The goal of this crossover study is to evaluate the systemic availability of short-chain fatty acids (SCFA) that are either administered in the small intestine or the colon in healthy volunteers. The main question it aims to answer is whether the site of administration affects the amount of SCFA that reaches the systemic circulation. On two test days participants will ingest capsules filled with SCFA that are specifically delivered in the small intestine or the colon. After ingestion, blood samples will be collected at regular time points.
- Being tested
- SCFA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCFADietary supplement
Participants will ingest the capsules during a standard no fiber breakfast. A primed continuous infusion containing SCFA will run during the whole test day. Blood sampling will continue for 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| small intestinal delivery capsules | Experimental | Participants will ingest small intestinal delivery capsules filled with short-chain fatty acids. Receives: Dietary Supplement: SCFA |
| Colon-delivery capsules | Experimental | Participants will ingest colon-delivery capsules filled with short-chain fatty acids. Receives: Dietary Supplement: SCFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of 13C-short-chain fatty acids in blood
Assessed by analysing SCFA in blood samples collected at regular time points
Measured: up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start9 Oct 2023
- Primary completion11 Mar 2024
- Study completion11 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic AvailabilityStudies 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
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Verbeke, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082726
- Sponsor's protocol ID
- S67256
- Acronym
- Sistine
- Status last verified
- Oct 2023
- First submitted
- 9 Oct 2023
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD data will be shared with other researchers.