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

NCT07655375 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-11

No results posted yet for this study

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.

Conditions

  • IBS (Irritable Bowel Syndrome)

Interventions

OTHER

Sample collection

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

Sponsors & Collaborators

  • UCB S.A. - Pharma Sector

    collaborator INDUSTRY

  • Guy Boeckxstaens

    lead OTHER

Principal Investigators

  • Guy Boecxkstaens, prof. dr. · Catholic University Leuven and Universitary Hospitals Leuven

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-10-31
Completion
2028-04-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07655375 on ClinicalTrials.gov