Study Evaluating the Effect of UCB8600 on Mast Cell Activation in the Human Gut (MASTGUT)

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 Overview

• Status: Not yet recruiting
• Conditions: IBS (Irritable Bowel Syndrome)
• Intervention / Treatment: Other: Sample collection

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ine De Booser, MSc; Phone Number: 0032-16-341943; Email: ine.debooser@uzleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • University Hospitals Leuven
      • Contact: Ine De Booser, MSc; Phone Number: 0032-16-341943; Email: ine.debooser@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria group 1 (resection tissue surgery patients = healthy volunteers):

1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures
2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
3. Undergoing surgery for colorectal cancer
4. No preoperative radiotherapy or chemotherapy

Exclusion Criteria group 1 (resection tissue surgery patients = healthy volunteers):

1. Using anti-histaminics such as ebastine, cetirizine, desloratadine, … (non-exhautive list) at the moment of surgery
2. Inflammatory bowel disease (IBD) or diverticulitis
3. Diabetes or BMI ≥ 30 kg/m²
4. Subject is legally incapacitated

Inclusion Criteria group 2 (rectal biopsies from IBS patients):

1. Voluntary written informed consent of the subject has been obtained prior to any screening procedures
2. At least 18 years of age at the time of signing the Informed Consent Form (ICF) and maximum age of 65 years of age at the time of signing the ICF
3. Diagnosed with IBS

Exclusion Criteria group 2 (rectal biopsies from IBS patients):

1. Subject has internal/external hemorrhoids at the moment of biopsy sampling.
2. Using blood-thinners such as Acenocoumarol, Aspirine (acetylsalicylzuur), Apixaban (Eliquis), Clopidogrel (Plavix), Dabigatran (Pradaxa), Edoxaban (Lixiana), Rivaroxaban (Xarelto), warfarine (Marevan®) and Enoxaparine (Clexane), … (non-exhausative list).
3. Using anti-histaminics such as ebastine, cetirizine, desloratadine, … (non-exhausative list) at the moment of biopsy sampling. Anti-histaminics should be stopped 2 weeks prior to the biopsy sampling.
4. Subject is legally incapacitated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Donation of resection material; Collection of colonic resection material of subjects undergoing abdominal surgery due to malignancies	Other: Sample collection; Collection of colonic resection material (surgery patients) and rectal biopsies (IBS patients)
Other: Rectal biopsies; Collection of rectal biopsies of IBS patients	Other: Sample collection; Collection of colonic resection material (surgery patients) and rectal biopsies (IBS patients)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	After finishing the essay, approximately on day 2

Collaborators and Investigators

• Sponsor: Guy Boeckxstaens
• Collaborators: UCB S.A. - Pharma Sector
• Investigators: Principal Investigator: Guy Boecxkstaens, prof. dr., Catholic University Leuven and Universitary Hospitals Leuven

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: IBS; irritable bowel syndrome; mast cells; UCB8600
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling
• Other Study ID Numbers: S71394

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No