- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00957398
Comparing of the Gastrointestinal Motility in Irritable Bowel Syndrome (IBS) Patients With Healthy Volunteers
Comparing of the Gastrointestinal Motility in Irritable Bowel Syndrome (IBS) Patients With Healthy Volunteers Using Magnetic Tracking System (MTS)
The hypothesis of the study is that the motility of the small intestine and the colon will alter according to the subtype of the irritable bowel syndrome (IBS) patient.
IBS is currently classified into following subtypes:
- Diarrhoea-IBS (IBS-D)
- Constipation-IBS (IBS-C)
- Mixed-IBS (IBS-M)
- Unsubtyped-IBS (IBS-U)
according to the Bristol scale.
Magnetic Tracking System (MTS) is a new minimal invasive technic that allows motility studies of the whole human gastrointestinal tract.
The magnetic cylindrical pill (6x15mm) is swallowed at 9 AM on day one. The recording is made until 4 PM and again from 8 AM until 2 PM on day two. The patient is placed in a bed and will be supplied with standardized food and fluid.
The Magnetic Tracking System consists of a 4 x 4 matrix of sensors positioned with respect to the anatomical reference points. Before measurements, the matrix is calibrated by offsetting the earth's and environmental magnetic fields. During the experiment, the magnet coordinates are continuously monitored and transmitted to a computer for processing and storage. Respiratory artifacts will be filtered out. Digestive movements will then be classified as 1) non-propulsive or 2) propulsive and transformed into either trajectory or dynamic graphs of the digestive motility.
The Magnetic Tracking System has the advantage from both radiographic and scintigraphic methods of conducting the tests without any radiation exposure to the patient. Preliminary studies have shown good concordance between the transit measured with the magnet and radiographic transit times.
The investigators wish to use this method, MTS, to compare the motility of the small intestine and the colon in patients with IBS-D and IBS-C as well as to compare these to groups to MTS done on healthy volunteers under the same conditions as the IBS patients.
연구 개요
상태
정황
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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-
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Aarhus, 덴마크
- Analfysiologisk Klinik, University of Aarhus
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients aged over 18.
- Patients who are diagnosed with IBS according to the Rome III criteria.
- A total symptom score in GSRS-IBS at a minimum of 40 points.
- Patients who are psychologically stable and suitable for observation and able to provide informed consent.
Exclusion Criteria:
- Overt bowel diseases including inflammatory bowel disease.
- Pregnant or breast feeding.
- Patients who are considered unable to follow the planned programme of the study, including mental illness or physiological instability.
- Patients who are on medication with known influence on gastrointestinal motility including those for thyroid disease, diabetes mellitus, celiac disease and neurological disease.
공부 계획
연구는 어떻게 설계됩니까?
코호트 및 개입
그룹/코호트 |
|---|
|
IBS-D
12 IBS-D patients who will all undergo MTS.
|
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IBS-C
12 IBS-C patients who will all undergo MTS.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Janne Fassov, PhDstudent, Analfysiologisk Klinik, University Hospital of Aarhus
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 20090009,JLF
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. .