a Low-residue Diet for Bowel Preparation

Not Applicable

Completed

• Conditions: Colorectal Adenoma; Colon Polyp
• Interventions: Dietary Supplement: Prepackaged Low-residue diet; Dietary Supplement: Self-prepared Low-residue diet

• Registration Number: NCT03943758
• Lead Sponsor: Changhai Hospital

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 available

Study Timeline

• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-09
• Study Start: 2019-05-10
• Primary Completion: 2020-12-10
• Study Completion: 2020-12-31
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 589

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prepackaged Low-residue diet group	Prepackaged Low-residue diet	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.
self-prepared Low-residue group	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

Primary Outcome Measures

Name	Time	Method
Adequate bowel preparation rate	30 mins	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.
BBPS scores of the entire colon	30 mins	The sum of the scores of three bowel segment.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Changhai Hospital, Second Military Medical University; 🇨🇳 Shanghai, China