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a Low-residue Diet for Bowel Preparation

Primary Purpose

Colon Polyp, Colorectal Adenoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Prepackaged Low-residue diet
Self-prepared Low-residue diet
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colon Polyp focused on measuring Bowel preparation, Polyp, adenoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Changhai Hospital, Second Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

prepackaged Low-residue diet group

self-prepared Low-residue group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
BBPS scores of the entire colon
The sum of the scores of three bowel segment.

Secondary Outcome Measures

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

Full Information

First Posted
May 8, 2019
Last Updated
December 21, 2021
Sponsor
Changhai Hospital
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT03943758
Brief Title
a Low-residue Diet for Bowel Preparation
Official Title
Effect of a Prepackaged Low-residue Diet on Bowel Preparation for Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
December 10, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Polyp, Colorectal Adenoma
Keywords
Bowel preparation, Polyp, adenoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
589 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prepackaged Low-residue diet group
Arm Type
Experimental
Arm Description
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.
Arm Title
self-prepared Low-residue group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Prepackaged Low-residue diet
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Self-prepared Low-residue diet
Intervention Description
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 Measure Information:
Title
Adequate bowel preparation rate
Description
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.
Time Frame
30 mins
Title
BBPS scores of the entire colon
Description
The sum of the scores of three bowel segment.
Time Frame
30 mins
Secondary Outcome Measure Information:
Title
adenoma detection rate (ADR)
Description
adenoma detection rate is the number of patients with at least one adenoma, divided by the total number of patients.
Time Frame
30 mins
Title
preparation completion rate
Description
preparation completion rate is the number of patients ingest more than 80% laxative, divided by the total number of patients.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoshen Li, M.D.
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital, Second Military Medical University
City
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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a Low-residue Diet for Bowel Preparation

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