Assessment of Safety, Quality, and Acceptance of a Bowel Preparation Using a Food Kit With Laxatives
2026년 5월 18일 업데이트: Joseph Spataro
A Single-Center, Randomized, Prospective, Single-Blinded Study to Assess the Safety, Quality, and Tolerance of a Bowel Preparation Using a Food Kit With Laxatives in a United States Veteran Population
The main purpose of this research study is to learn if an alternative bowel preparation (bowel prep) for colonoscopy is safe, tolerable and effective as compared to the standard bowel prep.
Participants are randomly assigned to receive one of the following bowel cleansing regimens for colonoscopy.
- Standard Bowel Prep which includes a clear liquid diet the day before the scheduled procedure and two doses of a laxative, polyethylene glycol 3350 (PEG-3350) taken with 4 liters of water.
- Happy Colon Foods Bowel Prep which begins the day before the scheduled procedure and contains various low residue foods (foods that are easily digested and absorbed), and seven doses of laxatives including PEG-3350 taken with a total of about 4 liters of water, senna tablets, and one dose of magnesium citrate.
연구 개요
상태
완전한
연구 유형
중재적
등록 (실제)
57
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Virginia
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Richmond, Virginia, 미국, 23249
- Central Virginia VA Health Care System
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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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Veterans undergoing index colonoscopy for colorectal cancer screening, including follow-up colonoscopy after a positive non-invasive stool-based test (e.g., fecal immunochemical test)
Exclusion Criteria:
- Personal history of colorectal cancer
- Inflammatory bowel disease
- Prior colon resection
- Antithrombotic therapy precluding polypectomy
- Pregnancy
- Hospitalization at the time of the scheduled procedure
- Celiac disease (food kit contained gluten products)
- Prior colonoscopy (cognitive bias)
- Chronic kidney disease stage 3 or higher
- Age 70 years or older.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Experimental: Food Kit with Laxatives (Happy Colon Foods)
Patients receive a commercially available prepackaged food and laxative kit (Happy Colon Foods) starting 24 hours before colonoscopy, including a low-residue diet and intermittent laxative regimen with PEG-3350 powder, senna tablets, and a single dose of magnesium citrate, following written and visual instructions.
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Low-residue diet food items and scheduled doses of PEG-3350, senna, and magnesium citrate prior to the colonoscopy
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활성 비교기: Control: Standard GoLYTELY Split-Dose Prep
Patients receive standard colonoscopy bowel preparation using a clear liquid diet for 24 hours before the procedure and split-dose 4 L polyethylene glycol 3350 electrolyte solution (PEG-3350; GoLYTELY) prior to the scheduled colonoscopy.
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Split-dose 4 L PEG-3350 electrolyte lavage solution taken the day before and morning of colonoscopy, combined with 24-hour clear liquid diet.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient acceptance/satisfaction
기간: Periprocedural
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Measure: Scores on a designed survey evaluating acceptance, ease of following instructions and willingness to repeat the preparation.
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Periprocedural
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quality of bowel preparation
기간: During colonoscopy (single procedure)
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Measure: Boston Bowel Preparation Scale (BBPS) score in right, transverse, and left colon; total score 0-9.
Adequate bowel preparation defined as total BBPS ≥ 6 with each segment score ≥ 2; proportion of patients achieving adequate prep compared between groups.
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During colonoscopy (single procedure)
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Patient-reported symptoms during bowel preparation
기간: Periprocedural
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Patient-reported symptoms (abdominal pain, cramping, bloating, nausea, vomiting, headaches, weakness, hunger, sleep difficulties) scored on a 5-point Likert scale (1 = none to 5 = severely distressing).
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Periprocedural
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Adverse events during bowel preparation
기간: Periprocedural
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Proportion of subjects with adverse events, defined as any symptom scored as 5 (severely distressing) on the Likert scale.
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Periprocedural
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Irrigation and suction time
기간: Periprocedural
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Time spent on irrigation and suction during colonoscopy, measured in minutes
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Periprocedural
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Colonoscopy withdrawal time
기간: Periprocedural
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Time from cecum to scope removal, measured in minutes
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Periprocedural
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Total colonoscopy procedure time
기간: Periprocedural
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Total time from scope insertion to removal, measured in minutes
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Periprocedural
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Cecal intubation rate
기간: Periprocedural
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Proportion of subjects with successful cecal intubation
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Periprocedural
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Adenoma detection rate
기간: Periprocedural
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Proportion of subjects with at least one adenoma detected
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Periprocedural
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Adenomas per colonoscopy
기간: Periprocedural
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Mean number of adenomas detected per colonoscopy
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Periprocedural
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Presence of diverticulosis
기간: Periprocedural
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Proportion of subjects with diverticulosis identified during colonoscopy
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Periprocedural
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Time to first bowel movement
기간: Periprocedural
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Interval from ingestion of bowel preparation laxative to the first bowel movement
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Periprocedural
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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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 (실제)
2022년 11월 1일
기본 완료 (실제)
2025년 6월 24일
연구 완료 (실제)
2025년 6월 24일
연구 등록 날짜
최초 제출
2026년 5월 11일
QC 기준을 충족하는 최초 제출
2026년 5월 18일
처음 게시됨 (실제)
2026년 5월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 18일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Individual participant data from this single-center VA study will not be shared outside the institution due to privacy and confidentiality protections for Veterans and lack of an approved external data-sharing mechanism.
Aggregate results will be disseminated through presentations and peer-reviewed publications.
약물 및 장치 정보, 연구 문서
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예
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아니
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아니
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. .