Study Evaluating the Effect of UCB8600 on Mast Cell Activation in the Human Gut
ConditionIBS (Irritable Bowel Syndrome)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGuy Boeckxstaens
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Sample collection
Other interventionCollection of colonic resection material (surgery patients) and rectal biopsies (IBS patients)
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Donation of resection materialOther 1 intervention
Group B: Rectal biopsiesOther 1 intervention
Trial outcomes
Primary outcomes
1
Total percentage of degranulated mast cells, detected using fluorescence microscopy
Using an avidin essay and fluorescence microscopy, the percentage of degranulated mast cells will be quantified
Time frame
After finishing the essay, approximately on day 22
Total corrected cellular fluorescence (TCCF) per mast cell
Using an avidin essay and fluorescence microscopy, the TCCF per mast cell will be quantified
Time frame
After finishing the essay, approximately on day 2Sponsors and contacts
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Source ClinicalTrials.gov