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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ine De Booser, MSc
- 전화번호: 0032-16-341943
- 이메일: ine.debooser@uzleuven.be
연구 장소
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, 벨기에, 3000
- University Hospitals Leuven
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연락하다:
- Ine De Booser, MSc
- 전화번호: 0032-16-341943
- 이메일: ine.debooser@uzleuven.be
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria group 1 (resection tissue 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 surgery patients = healthy volunteers):
- Using anti-histaminics 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 at the time of signing the Informed Consent Form (ICF) and maximum age of 65 years of age at the time of signing the 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 blood-thinners such as Acenocoumarol, Aspirine (acetylsalicylzuur), Apixaban (Eliquis), Clopidogrel (Plavix), Dabigatran (Pradaxa), Edoxaban (Lixiana), Rivaroxaban (Xarelto), warfarine (Marevan®) and Enoxaparine (Clexane), … (non-exhausative list).
- Using anti-histaminics such as ebastine, cetirizine, desloratadine, … (non-exhausative list) at the moment of biopsy sampling. Anti-histaminics should be stopped 2 weeks prior to the biopsy sampling.
- Subject is legally incapacitated
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: Donation of resection material
Collection of colonic resection material of subjects undergoing abdominal surgery due to malignancies
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Collection of colonic resection material (surgery patients) and rectal biopsies (IBS patients)
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다른: Rectal biopsies
Collection of rectal biopsies of IBS patients
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Collection of colonic resection material (surgery patients) and rectal biopsies (IBS patients)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Total percentage of degranulated mast cells, detected using fluorescence microscopy
기간: After finishing the essay, approximately on day 2
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Using an avidin essay and fluorescence microscopy, the percentage of degranulated mast cells will be quantified
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After finishing the essay, approximately on day 2
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Total corrected cellular fluorescence (TCCF) per mast cell
기간: After finishing the essay, approximately on day 2
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Using an avidin essay and fluorescence microscopy, the TCCF per mast cell will be quantified
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After finishing the essay, approximately on day 2
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Guy Boecxkstaens, prof. dr., Catholic University Leuven and Universitary Hospitals Leuven
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- S71394
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Sample collection에 대한 임상 시험
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The Hong Kong Polytechnic UniversityLogistics and Supply Chain MultiTech R&D Centre, Hong Kong모병
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The University of QueenslandBecton, Dickinson and Company모병