UCB8600 and mast cell activation in the gut for IBS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates whether UCB8600 can limit mast cell activation in the human gut, a factor thought to contribute to IBS symptoms. The research will analyze intestinal tissue and rectal biopsies to assess histamine release and related nerve sensitivity after UCB8600 exposure. Participants include adults undergoing colorectal surgery (for healthy tissue samples) and adults with IBS providing rectal biopsies. The trial is led by Guy Boeckstaens at University Hospitals Leuven, with UCB S.A. as a collaborator, and uses sample collection as the primary intervention. If successful, the approach could lead to a future therapeutic option for IBS.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospitals Leuven
  Leuven, Vlaams-Brabant, Belgium Recruiting

Study contacts

• Principal investigator: Guy Boecxkstaens, prof. dr. — Catholic University Leuven and Universitary Hospitals Leuven
• Study coordinator: Ine De Booser, MSc
• Email: ine.debooser@uzleuven.be
• Phone: 0032-16-341943

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.