IBS (Irritable Bowel Syndrome)MASTGUTNCT07655375
Study Evaluating the Effect of UCB8600 on Mast Cell Activation in the Human Gut
A study testing Sample collection in people with IBS (Irritable Bowel Syndrome), run by Guy Boeckxstaens at 1 site in Belgium.
Trial summary
Study evaluating the effect of UCB8600 on mast cell activation in the human gut: IBS is a disease characterized by abdominal pain and a change in stool. Treatment is limited to an adapted life style, dietary changes and medication to lessen cramps (spasmolytica), all of which have seen limited to no clinical success. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- IBS (Irritable Bowel Syndrome)
- What is being tested?
- Sample collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Aug 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria group 1 (resection tissue from surgery patients = healthy volunteers):
- Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- Undergoing surgery for colorectal cancer
- No preoperative radiotherapy or chemotherapy
Exclusion Criteria group 1 (resection tissue from surgery patients = healthy volunteers):
- Using antihistamines such as ebastine, cetirizine, desloratadine, … (non-exhautive list) at the moment of surgery
- Inflammatory bowel disease (IBD) or diverticulitis
- Diabetes or BMI ≥ 30 kg/m²
- Subject is legally incapacitated
Inclusion Criteria group 2 (rectal biopsies from IBS patients):
- Voluntary written informed consent of the subject has been obtained prior to any screening procedures
- At least 18 years of age and maximum age of 65 years of age at the time of signing the Informed Consent Form (ICF)
- Diagnosed with IBS
Exclusion Criteria group 2 (rectal biopsies from IBS patients):
- Subject has internal/external hemorrhoids at the moment of biopsy sampling.
- Using bloodthinners such as Acenocoumarol, Aspirine (acetylsalicylzuur), Apixaban (Eliquis), Clopidogrel (Plavix), Dabigatran (Pradaxa), Edoxaban (Lixiana), Rivaroxaban (Xarelto), warfarine (Marevan®) and Enoxaparine (Clexane), … (non-exhausative list).
- Using antihistamines such as ebastine, cetirizine, desloratadine, … (non-exhausative list) at the moment of biopsy sampling. These should be stopped 2 weeks prior to the biopsy sampling.
- Subject is legally incapacitated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000
Ine De Booser, MSc, 0032-16-341943, ine.debooser@uzleuven.be
About this study
Study evaluating the effect of UCB8600 on mast cell activation in the human gut:
IBS is a disease characterized by abdominal pain and a change in stool. Treatment is limited to an adapted life style, dietary changes and medication to lessen cramps (spasmolytica), all of which have seen limited to no clinical success.
Recently, we were able to demonstrate that mast cells play an active role in IBS symptoms. More specifically, they set histamine free when activated which heightens nerve sensitivity in the intestines which probably contributes to the abdominal pain. A new product called "UCB8600" is hypothesized to be able to counteract this by causing less mast cells to be activated. In this study we'll test this by administering UCB8600 on intestinal tissue and see if there is less mast cell activation. If the study produces good results, this new product could potentially be used as a treatment for IBS in the future.
- Conditions
- IBS (Irritable Bowel Syndrome)
- Being tested
- Sample collection
- Keywords
- IBS, irritable bowel syndrome, UCB8600, mast cells
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectionOther
Collection of colonic resection material (surgery patients) and rectal biopsies (IBS patients)
| Study group | Role | What they receive |
|---|---|---|
| Donation of resection material | Other | Collection of colonic resection material of subjects undergoing abdominal surgery due to malignancies Receives: Other: Sample collection |
| Rectal biopsies | Other | Collection of rectal biopsies of IBS patients Receives: Other: Sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total percentage of degranulated mast cells, detected using fluorescence microscopy
Using an avidin essay and fluorescence microscopy, the percentage of degranulated mast cells will be quantified
Measured: After finishing the essay, approximately on day 2
Total corrected cellular fluorescence (TCCF) per mast cell
Using an avidin essay and fluorescence microscopy, the TCCF per mast cell will be quantified
Measured: After finishing the essay, approximately on day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start18 Aug 2026
- Primary completionOct 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS (Irritable Bowel Syndrome)Studies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy Boeckxstaens
- Sponsor type
- University, hospital or other
- Collaborators
- UCB S.A. - Pharma Sector
- Responsible party
- Sponsor-investigator, Guy Boeckxstaens, KU Leuven
- Investigators
- Guy Boecxkstaens, prof. dr., Principal investigator, Catholic University Leuven and Universitary Hospitals Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655375
- Sponsor's protocol ID
- S71394
- Acronym
- MASTGUT
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating the Effect of UCB8600 on Mast Cell Activation in the Human Gut
- ClinicalTrials.gov ID
- NCT07655375
- Acronym / sponsor ID
- MASTGUT / S71394
- Conditions
- IBS (Irritable Bowel Syndrome)
- Keywords
- IBS, irritable bowel syndrome, UCB8600, mast cells
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guy BoeckxstaensUniversity, hospital or other
- Collaborators
- UCB S.A. - Pharma Sector
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 17 Jun 2026 (actual)
- 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.
Study evaluating the effect of UCB8600 on mast cell activation in the human gut:
IBS is a disease characterized by abdominal pain and a change in stool. Treatment is limited to an adapted life style, dietary changes and medication to lessen cramps (spasmolytica), all of which have seen limited to no clinical success.
Recently, we were able to demonstrate that mast cells play an active role in IBS symptoms. More specifically, they set histamine free when activated which heightens nerve sensitivity in the intestines which probably contributes to the abdominal pain. A new product called "UCB8600" is hypothesized to be able to counteract this by causing less mast cells to be activated. In this study we'll test this by administering UCB8600 on intestinal tissue and see if there is less mast cell activation. If the study produces good results, this new product could potentially be used as a treatment for IBS in the future.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donation of resection material | Other | Other: Sample collectionCollection of colonic resection material of subjects undergoing abdominal surgery due to malignancies |
| Rectal biopsies | Other | Other: Sample collectionCollection of rectal biopsies of IBS patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Sample collectionCollection of colonic resection material (surgery patients) and rectal biopsies (IBS patients) | Other | Donation of resection material, Rectal biopsies |
Primary outcome
Total percentage of degranulated mast cells, detected using fluorescence microscopy
Time frame: After finishing the essay, approximately on day 2
Using an avidin essay and fluorescence microscopy, the percentage of degranulated mast cells will be quantified
Total corrected cellular fluorescence (TCCF) per mast cell
Time frame: After finishing the essay, approximately on day 2
Using an avidin essay and fluorescence microscopy, the TCCF per mast cell will be quantified
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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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.
Guy Boecxkstaens, prof. dr. principal investigator
Catholic University Leuven and Universitary Hospitals Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sample collection in people with IBS (Irritable Bowel Syndrome), run by Guy Boeckxstaens at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ine De Booser, MSc (0032-16-341943, ine.debooser@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total percentage of degranulated mast cells, detected using fluorescence microscopy (time frame: After finishing the essay, approximately on day 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 10 Sep 2026.