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出境医 / 临床实验 / a Low-residue Diet for Bowel Preparation
a Low-residue Diet for Bowel Preparation
Study Description
Brief Summary:
Previous researches demonstrated that a prepackaged low-residue diet (LRD) could achieve better bowel preparation quality compared with a self-prepared LRD. However, up to now, there has been no widely acceptable standard of LRD for bowel preparation. Moreover, these prepackaged LRD adopted in previous studies mainly consisted of traditional foods without further processing. Recently, a prepackaged LRD for Special Medical Purpose was specifically designed for bowel preparation. This trail was to compare the impact of the prepackaged LRD on bowel preparation for colonoscopy with self-prepared LRD by patients.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colon Polyp Colorectal Adenoma | Dietary Supplement: Prepackaged Low-residue diet Dietary Supplement: Self-prepared Low-residue diet | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 800 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Care Provider, Outcomes Assessor) |
| Primary Purpose: | Diagnostic |
| Official Title: | Effect of a Prepackaged Low-residue Diet on Bowel Preparation for Colonoscopy |
| Actual Study Start Date : | May 10, 2019 |
| Estimated Primary Completion Date : | December 10, 2019 |
| Estimated Study Completion Date : | December 31, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
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Experimental: prepackaged Low-residue diet group
The prepackaged Low-residue diet (Maifu Nutrition Technology Co. Ltd, Beijing, China). One package of the prepackaged Low-residue diet contained quantity of heat amounts to 268 kilocalories with 12.0 g of protein, 9.6 g of lipid, and 34.1 g of carbohydrate.
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Dietary Supplement: Prepackaged Low-residue diet
Subjects in the prepackaged Low-residue diet group were given three packages of the prepackaged Low-residue diet, and instructed to ingest one package per meal without any other food being allowed in the day prior to colonoscopy.
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Active Comparator: self-prepared Low-residue group
Subjects in the self-prepared Low-residue diet group were instructed to follow and prepare an Low-residue diet in the day prior to colonoscopy
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Dietary Supplement: Self-prepared Low-residue diet
Subjects in the self-prepared Low-residue diet group were instructed to follow and prepare an Low-residue diet in the day prior to colonoscopy.
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Outcome Measures
Primary Outcome Measures :
- Boston bowel preparation scale (BBPS) scores [ Time Frame: 30 mins ]BBPS was developed to evaluate the quality of colon preparation and was used in our previous study. Each section of the colon (i.e. the right, the transverse, and the rectosigmoid colon) was rated (0, very poor; 1, poor; 2, good; and 3, very good). Adequate bowel of bowel preparation was defined as a total BBPS score ≥ 6 and all colon segments BBPS ≥ 2. Inadequate bowel preparation was defined as any colon segment BBPS ≤ 1.
- adequate bowel preparation rate [ Time Frame: 30 mins ]Adequate bowel of bowel preparation was defined as a total BBPS score ≥ 6 and all colon segments BBPS ≥ 2. Inadequate bowel preparation was defined as any colon segment BBPS ≤ 1
Secondary Outcome Measures :
- adenoma detection rate (ADR) [ Time Frame: 30 mins ]adenoma detection rate is the number of patients with at least one adenoma, divided by the total number of patients.
- preparation completion rate [ Time Frame: 1 day ]preparation completion rate is the number of patients ingest more than 90% laxative, divided by the total number of patients.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients whose age is between 18-75.
- Patients who have indications for screening, surveillance and diagnostic colonoscopy.
- Patients who have signed inform consent form
Exclusion Criteria:
- Patients who have undergone colonic resection
- Patients with intracranial and/or central nervous system disease, including cerebral infarction and cerebral hemorrhage.
- Patients with severe chronic cardiopulmonary and renal disease.
- Patients who are unwilling or unable to consent.
- Patients who are not suitable for colonoscopy
- Patients who received urgent or therapeutic colonoscopy
- Patients with pregnancy or breastfeeding, inflammatory bowel disease, polyposis of colon, BMI >30, colorectal cancer, diabetes mellitus, or intestinal obstruction
- Patients who are taking aspirin, clopidogrel or other anticoagulants
- Patients who are known allergies to any ingredients of the LRFP and polyethylene glycol-electrolyte lavage solution
Contacts and Locations
Contacts
| Contact: Zhaoshen Li, M.D. | 86-21-31161365 | li.zhaoshen@hotmail.com | |
| Contact: Yu Bai, M.D. | +86-21-31161335 | baiyu1998@hotmail.com |
Locations
| China | |
| Changhai Hospital, Second Military Medical University | Recruiting |
| Shanghai, China, 200433 | |
| Contact: bai yu, M.D 86-21-81873241 baiyu1998@hotmail.com | |
| Contact: zhao shengbing, M.D 86-21-81873241 zhaoshengbing@hotmail.com | |
Sponsors and Collaborators
Changhai Hospital
Qilu Hospital of Shandong University
Jinan Military General Hospital
Wuhan TongJi Hospital
Zhejiang University
First Affiliated Hospital, Sun Yat-Sen University
The First Affiliated Hospital with Nanjing Medical University
West China Hospital
Investigators
| Principal Investigator: | Zhaoshen Li, M.D. | Changhai Hospital |
| Tracking Information | |||||||||
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| First Submitted Date ICMJE | May 8, 2019 | ||||||||
| First Posted Date ICMJE | May 9, 2019 | ||||||||
| Last Update Posted Date | August 14, 2019 | ||||||||
| Actual Study Start Date ICMJE | May 10, 2019 | ||||||||
| Estimated Primary Completion Date | December 10, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | a Low-residue Diet for Bowel Preparation | ||||||||
| Official Title ICMJE | Effect of a Prepackaged Low-residue Diet on Bowel Preparation for Colonoscopy | ||||||||
| Brief Summary | Previous researches demonstrated that a prepackaged low-residue diet (LRD) could achieve better bowel preparation quality compared with a self-prepared LRD. However, up to now, there has been no widely acceptable standard of LRD for bowel preparation. Moreover, these prepackaged LRD adopted in previous studies mainly consisted of traditional foods without further processing. Recently, a prepackaged LRD for Special Medical Purpose was specifically designed for bowel preparation. This trail was to compare the impact of the prepackaged LRD on bowel preparation for colonoscopy with self-prepared LRD by patients. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Care Provider, Outcomes Assessor) Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
800 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 31, 2019 | ||||||||
| Estimated Primary Completion Date | December 10, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03943758 | ||||||||
| Other Study ID Numbers ICMJE | Low-residue | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Zhaoshen Li, Changhai Hospital | ||||||||
| Study Sponsor ICMJE | Changhai Hospital | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Changhai Hospital | ||||||||
| Verification Date | August 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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