RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Sample collection for IBS (Irritable Bowel Syndrome)

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.

Official registry: https://clinicaltrials.gov/study/NCT07655375 · Guy Boeckxstaens · enrollment listed as 60

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Sample collection. The registry lists allocation as randomized. 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.

They plan to enroll about 60 people at Leuven. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

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

Interventions: Sample collection

Primary outcome (registry wording): Total percentage of degranulated mast cells, detected using fluorescence microscopy

Who it is for (from inclusion criteria)

Ages 18 Years to 65 Years
group 1 (resection tissue from surgery patients = healthy volunteers):
Undergoing surgery for colorectal cancer
No preoperative radiotherapy or chemotherapy

Who the registry excludes

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 body-mass index (BMI) ≥ 30 kg/m²
Subject is legally incapacitated
who can join group 2 (rectal biopsies from IBS patients):

Public study contact (from the registry)

Ine De Booser, MSc

0032-16-341943

ine.debooser@uzleuven.be

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

University Hospitals Leuven — Leuven, Vlaams-Brabant, Belgium (recruiting)

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FAQ about this NCT record

Is NCT07655375 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07655375?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07655375?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary