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NCT Number: NCT07655375

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sample collection

Other

Collection of colonic resection material (surgery patients) and rectal biopsies (IBS patients)

Primary outcomes

  1. Total percentage of degranulated mast cells, detected using fluorescence microscopy

    Time frame: After finishing the essay, approximately on day 2

    Using an avidin essay and fluorescence microscopy, the percentage of degranulated mast cells will be quantified

  2. Total corrected cellular fluorescence (TCCF) per mast cell

    Time frame: After finishing the essay, approximately on day 2

    Using an avidin essay and fluorescence microscopy, the TCCF per mast cell will be quantified

Study contacts

Contact information is provided by the study sponsor or research team.

Ine De Booser, MSc

CONTACT

[email protected]

0032-16-341943

Sponsors and collaborators

Lead sponsor

Guy Boeckxstaens

Other

Collaborators

  • UCB S.A. - Pharma Sector

Registry information

Acronym: MASTGUT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 17, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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