- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01114113
Assessment of Gastric Emptying Speed in Patients Who Experience Diarrhea Following a Trigger Meal
2012년 4월 18일 업데이트: Mary E. Money, M.D., Money, Mary E., M.D.
Pilot Study: Assessment of Gastric and Intestinal Motility Following a Trigger Meal in Patients With Post Prandial Diarrhea
The rapid diarrhea that patients experience who have diarrhea occurring after eating specific foods may be causing a "physiologic gastric dumping syndrome".
This means that rather than the food being kept in the stomach for normal digestion, it rapidly goes into the small intestine and diarrhea occurs.
This study is designed to measure how fast the food empties from the stomach when a person with this problem consumes a "regular diet", compared to a meal with a "triggering substance".
Each participant will swallow a radio frequency capsule that with the different meals that will show how fast the food is traveling through the intestines in the different situations.
연구 개요
상태
빼는
정황
상세 설명
Since some patients have found that pancreatic enzymes seem to ameliorate this diarrhea from occurring,willing participants will be asked to duplicate the "triggering meal" 2 more times.
Once taking a pancreatic enzyme (active drug) with the meal and a second time taking an identical placebo.
Neither the participant nor the study investigator will know which capsule is the active drug in this phase of the study.
Willing participants will receive a small stipend each time they swallow the radio frequency capsule.
This capsule is large, approximately twice the size of a vitamin pill so individuals must have no difficulties with swallow to participate nor any history of bowel obstruction or major surgery to the abdominal which might have caused adhesions.
연구 유형
중재적
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- The patient must have been diagnosed as having post prandial diarrhea for at least 5 years by his/her primary care physician or gastroenterologist and is believed to have no other medical condition that would cause this medical problem. Each person must be over 18 years old and have negative testing for Celiac Disease, a normal colonoscopy within 5 years of enrollment, and a normal Hgb and sedimentation rate within 6 months of enrollment in the trial.
- The patient has provided documented written informed consent/authorization prior to initiation of any study-related procedure.
- In addition, each patient must report experiencing the onset of urgent defecation within 1 hours of eating a specific trigger which is reproducible at least 90% of the time when consume.
- The patient must be willing to comply with all of the study protocol.
Exclusion Criteria:
- The patient has had any rectal bleeding or bloody stools within the last 2 years not completely evaluated by a physician. If rectal bleeding has occurred, and the patient wants to be considered for the study, the diagnostic workup must have clearly identified the etiology for the bleeding and excluded the medical conditions listed under 3 below. The patient must be willing to allow the Study team to obtain these records for verification of the diagnosis.
- The patient has nocturnal bowel movements.
- The patient has been diagnosed with or has a family history of any of the following: ulcerative colitis, Crohn's Disease, celiac disease, sprue, other inflammatory bowel disease or has a positive test for celiac disease on screening lab and has not had a full investigation performed to exclude celiac disease.
- The patient has had unexplained anorexia or weight loss of more than 10% of body weight within 12 months of onset of study.
- Prior GI surgery except of uncomplicated appendectomy and laparoscopic cholecystectomy or history of bowel obstruction or symptoms suggestive of such within the past 2 years.
- The patient reports daily use of laxatives or stool softeners; use of fiber supplementation is permitted.
- The patient is currently using pancrealipase. Previous use of pancrealipase in the past is allowed, but patients must be off either of the medication for at least 1 week or until the patient's symptoms of post prandial diarrhea returns before participating in the study.
- Use of implanted or ambulatory electromechanical medical devices such as pacemakers, insulin pumps, and infusion pumps.
- History of gastroparesis or chronic use of reglan.
- Dysphagia to solid food and pills.
- Previous gastro-esophageal surgery including vagotomy, fundoplication, gastric bypass or ulcer surgery.
- Tobacco use within eight hours prior to capsule ingestion and during the 8 hour monitoring time.
- Alcohol use within 24 hours prior to capsule ingestion and throughout the entire monitoring period (up to 72 hours).
- BMI > 35
- Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: non-trigger meal
Measurement of intestinal transport eating a "non-trigger meal".
|
Measurement of a baseline, non-trigger meal intestinal transit by using the SmartPill capsule.
Measurement of intestinal transit of a "trigger meal" baseline by using the SmartPill capsule
SmartPill capsule
|
|
활성 비교기: "trigger meal baseline"
Measurement of intestinal transport after eating a "trigger meal".
|
Measurement of a baseline, non-trigger meal intestinal transit by using the SmartPill capsule.
Measurement of intestinal transit of a "trigger meal" baseline by using the SmartPill capsule
SmartPill capsule
|
|
위약 비교기: "trigger meal" with placebo
Measurement of intestinal transport with blinded placebo
|
Measurement of a baseline, non-trigger meal intestinal transit by using the SmartPill capsule.
Measurement of intestinal transit of a "trigger meal" baseline by using the SmartPill capsule
SmartPill capsule
ZenPep 20000 units of lipase will be provided for the participant to take with a trigger meal or an identical placebo.
This will only be given to those participants willing to consume 2 more identical "trigger meals" and will not be given for the initial baseline "non-trigger" and baseline "trigger meal".
In both of these arms, patients will also be swallowing the SmartPill Capsule.
|
|
활성 비교기: "trigger meal" with enzymes (blinded)
Measurement of intestinal transport with blinded active enzyme capsule
|
Measurement of a baseline, non-trigger meal intestinal transit by using the SmartPill capsule.
Measurement of intestinal transit of a "trigger meal" baseline by using the SmartPill capsule
SmartPill capsule
ZenPep 20000 units of lipase will be provided for the participant to take with a trigger meal or an identical placebo.
This will only be given to those participants willing to consume 2 more identical "trigger meals" and will not be given for the initial baseline "non-trigger" and baseline "trigger meal".
In both of these arms, patients will also be swallowing the SmartPill Capsule.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Duration of intestinal speed of a "trigger meal" compared to a non-trigger meal baseline. Optional study comparing intestinal speed of trigger meal using Pancrelipase compared to placebo.
기간: 72 hour measurement per meal
|
Data from the SmartPill radiofrequency capsule that is swallowed at the beginning of the different meals will be recorded and compared.
|
72 hour measurement per meal
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Mary E Money, M.D., Washington County Hospital
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 4월 1일
기본 완료 (실제)
2011년 1월 1일
연구 완료 (실제)
2011년 1월 1일
연구 등록 날짜
최초 제출
2010년 4월 25일
QC 기준을 충족하는 최초 제출
2010년 4월 29일
처음 게시됨 (추정)
2010년 4월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 4월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 4월 18일
마지막으로 확인됨
2012년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2010IBS-G/D eval
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. .