a Low-residue Diet for Bowel Preparation

Study Overview
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Brief Summary
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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.

Official Title
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Effect of a Prepackaged Low-residue Diet on Bowel Preparation for Colonoscopy

Conditions
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Colon Polyp, Colorectal Adenoma

Intervention / Treatment
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* Dietary Supplement: Prepackaged Low-residue diet
* Dietary Supplement: Self-prepared Low-residue diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients whose age is between 18-65. Patients who have indications for screening, surveillance and diagnostic colonoscopy. Patients who have signed inform consent form Exclusion Criteria: subjects who had known or suspected heart failure, stroke or renal failure; subjects who had a history of colon surgery or inflammatory bowel disease; subjects who Patients with had digestion or absorption dysfunction or any dietary restriction due to various reasons; subjects who had a history of hypersensitivity to any ingredients of laxatives or soy products; subjects who had high risk factors for bowel preparation such as chronic constipation, Body Mass Index (BMI) greater than 30 or BMI less than 18 Kg/m2, diabetes, spinal cord injury, or use of medications affecting bowel motility within a week; subjects who had participated in another interventional clinical trial in the previous 60 days; pregnant or lactating women and those planning to become pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prepackaged Low-residue diet group<br>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. | Dietary Supplement: Prepackaged Low-residue diet<br>* Subjects in the prepackaged Low-residue diet group were given 6 packs (60g/pack) pre-packaged formula LRD and asked to use the formula according to individual needs prior to colonoscopy.<br>|
| Active Comparator: self-prepared Low-residue group<br>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 | Dietary Supplement: Self-prepared Low-residue diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate bowel preparation rate | Boston Bowel Preparation Scale (BBPS) was adopted to evaluate the quality of bowel preparation. 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 score ≥ 6 and all colon segments BBPS ≥ 2. Inadequate bowel preparation was defined as any colon segment BBPS ≤ 1. | 30 mins | 
| BBPS scores of the entire colon | The sum of the scores of three bowel segment. | 30 mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adenoma detection rate (ADR) | adenoma detection rate is the number of patients with at least one adenoma, divided by the total number of patients. | 30 mins | 
| preparation completion rate | preparation completion rate is the number of patients ingest more than 80% laxative, divided by the total number of patients. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowel preparation, Polyp, adenoma