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

Trial statusNot yet recruiting
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

Qualifiers

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

Treatments tested in this trial

  • Sample collection

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Guy Boeckxstaens

Lead sponsor

KU Leuven

Sponsor institution

UCB S.A. - Pharma Sector

Collaborator