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Could a new drug calm the gut and stop IBS pain?

NCT ID NCT07655375

Knowledge-focused Sponsor: Guy Boeckxstaens Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 5 times

Summary

This study looks at whether a new drug called UCB8600 can stop mast cells in the gut from overreacting, which may cause pain in people with irritable bowel syndrome (IBS). Researchers will take gut tissue from 60 people (some with IBS, some healthy) and treat it with UCB8600 in the lab. They will then measure how many mast cells are activated. This is a very early, lab-based study to see if the drug works as hoped.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
UCB8600
What this could lead to
If successful, this could point toward a new treatment for IBS by reducing mast cell activation and easing abdominal pain.
What could go wrong
This is a very early lab study using tissue samples, not a full clinical trial in patients. It may not translate into an effective treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria group 1 (resection tissue from 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 from surgery patients = healthy volunteers): 1. Using antihistamines 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 and maximum age of 65 years of age at the time of signing the Informed Consent Form (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 bloodthinners 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 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. 4. Subject is legally incapacitated

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Conditions

The condition(s) this trial relates to.

colorectal cancer irritable bowel syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

IBS - irritable bowel syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospitals Leuven

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

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