NCT07655375

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jun 2026Apr 2028

Study Start

First participant enrolled

June 1, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 12, 2026

Last Update Submit

June 12, 2026

Conditions

IBS (Irritable Bowel Syndrome)

Keywords

IBSirritable bowel syndromeUCB8600mast cells

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Donation of resection material

OTHER

Collection of colonic resection material of subjects undergoing abdominal surgery due to malignancies

Other: Sample collection

Rectal biopsies

OTHER

Collection of rectal biopsies of IBS patients

Other: Sample collection

Interventions

Sample collectionOTHER

Collection of colonic resection material (surgery patients) and rectal biopsies (IBS patients)

Donation of resection materialRectal biopsies

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Using anti-histaminics 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
  • Voluntary written informed consent of the subject has been obtained prior to any screening procedures
  • 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
  • Diagnosed with IBS
  • Subject has internal/external hemorrhoids at the moment of biopsy sampling.
  • 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).
  • 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.
  • Subject is legally incapacitated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Guy Boecxkstaens, prof. dr.

    Catholic University Leuven and Universitary Hospitals Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ine De Booser, MSc

CONTACT

0032-16-341943ine.debooser@uzleuven.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 17, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

June 17, 2026

Record last verified: 2026-06

Locations

BE(1)