- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07655375
Study Evaluating the Effect of UCB8600 on Mast Cell Activation in the Human Gut (MASTGUT)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Ine De Booser, MSc
- Telefonnummer: 0032-16-341943
- E-post: ine.debooser@uzleuven.be
Studieorter
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgien, 3000
- Rekrytering
- University Hospitals Leuven
-
Kontakt:
- Ine De Booser, MSc
- Telefonnummer: 0032-16-341943
- E-post: ine.debooser@uzleuven.be
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Donation of resection material
Collection of colonic resection material of subjects undergoing abdominal surgery due to malignancies
|
Collection of colonic resection material (surgery patients) and rectal biopsies (IBS patients)
|
|
Övrig: Rectal biopsies
Collection of rectal biopsies of IBS patients
|
Collection of colonic resection material (surgery patients) and rectal biopsies (IBS patients)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Total percentage of degranulated mast cells, detected using fluorescence microscopy
Tidsram: After finishing the essay, approximately on day 2
|
Using an avidin essay and fluorescence microscopy, the percentage of degranulated mast cells will be quantified
|
After finishing the essay, approximately on day 2
|
|
Total corrected cellular fluorescence (TCCF) per mast cell
Tidsram: After finishing the essay, approximately on day 2
|
Using an avidin essay and fluorescence microscopy, the TCCF per mast cell will be quantified
|
After finishing the essay, approximately on day 2
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Guy Boecxkstaens, prof. dr., Catholic University Leuven and Universitary Hospitals Leuven
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- S71394
Läkemedels- och apparatinformation, studiedokument
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