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Not yet recruiting NCT07655375

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

No phase Interventional IBS (Irritable Bowel Syndrome)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sample collection.
Who it may be relevant to
Registry conditions: IBS (Irritable Bowel Syndrome). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Sample collection
    Collection of colonic resection material (surgery patients) and rectal biopsies (IBS patients)

Primary outcome measures

  • Total percentage of degranulated mast cells, detected using fluorescence microscopy [Time frame: After finishing the essay, approximately on day 2]
  • Total corrected cellular fluorescence (TCCF) per mast cell [Time frame: After finishing the essay, approximately on day 2]

Eligibility criteria

Inclusion Criteria group 1 (resection tissue from surgery patients = healthy volunteers):

  • 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

Exclusion Criteria 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 BMI ≥ 30 kg/m²
  • Subject is legally incapacitated

Inclusion Criteria group 2 (rectal biopsies from IBS patients):

  • Voluntary written informed consent of the subject has been obtained prior to any screening procedures
  • At least 18 years of age and maximum age of 65 years of age at the time of signing the Informed Consent Form (ICF)
  • Diagnosed with IBS

Exclusion Criteria group 2 (rectal biopsies from IBS patients):

  • Subject has internal/external hemorrhoids at the moment of biopsy sampling.
  • 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).
  • 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.
  • Subject is legally incapacitated

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Belgium · 1 center
  • University Hospitals Leuven — Leuven

Identifiers

NCT: NCT07655375 · S71394

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗