a Low-residue Diet for Bowel Preparation

Sponsor

Changhai Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03943758

Collaborator

Qilu Hospital of Shandong University (Other), Jinan Military General Hospital (Other), Wuhan TongJi Hospital (Other), Zhejiang University (Other), First Affiliated Hospital, Sun Yat-Sen University (Other), The First Affiliated Hospital with Nanjing Medical University (Other), West China Hospital (Other)

589

Enrollment

Location

Arms

19.7

Actual Duration (Months)

29.8

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

589 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

Actual Primary Completion Date :

Dec 10, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.	Dietary Supplement: Prepackaged Low-residue diet 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.
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	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.

Arm

Intervention/Treatment

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.

Dietary Supplement: Prepackaged Low-residue diet

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.

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

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.

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Changhai Hospital, Second Military Medical University	Shanghai		China	200433

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhaoshen Li, Director of Gastroenterology Dept, Changhai Hospital

ClinicalTrials.gov Identifier:

NCT03943758

Other Study ID Numbers:

Low-residue

First Posted:

May 9, 2019

Last Update Posted:

Jan 11, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zhaoshen Li, Director of Gastroenterology Dept, Changhai Hospital

Bowel preparation

Polyp

adenoma

Additional relevant MeSH terms:

Adenoma

Study Results

No Results Posted as of Jan 11, 2022