IBS (Irritable Bowel Syndrome)
Conditions
Keywords
IBS, irritable bowel syndrome, UCB8600, mast cells
Brief summary
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
OTHERSample collection
Collection of colonic resection material (surgery patients) and rectal biopsies (IBS patients)
Sponsors
Guy Boeckxstaens
UCB S.A. - Pharma Sector
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total percentage of degranulated mast cells, detected using fluorescence microscopy | After finishing the essay, approximately on day 2 | Using an avidin essay and fluorescence microscopy, the percentage of degranulated mast cells will be quantified |
| Total corrected cellular fluorescence (TCCF) per mast cell | After finishing the essay, approximately on day 2 | Using an avidin essay and fluorescence microscopy, the TCCF per mast cell will be quantified |
Countries
Belgium
Contacts
CONTACTIne De Booser, MSc
PRINCIPAL_INVESTIGATORGuy Boecxkstaens, prof. dr.
Catholic University Leuven and Universitary Hospitals Leuven
Outcome results
None listed