a Low-residue Diet for Bowel Preparation

• ClinicalTrials.gov Identifier: NCT03943758
• Recruitment Status: Completed
• First Posted: May 9, 2019
• Last Update Posted: January 11, 2022
• 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
• Information provided by (Responsible Party): Zhaoshen Li, Changhai Hospital

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)
• 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: December 10, 2020
• Actual Study Completion Date: December 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.

Outcome Measures

Primary Outcome Measures :

1. Adequate bowel preparation rate [ Time Frame: 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.
2. BBPS scores of the entire colon [ Time Frame: 30 mins ]
   The sum of the scores of three bowel segment.

Secondary Outcome Measures :

1. 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.
2. preparation completion rate [ Time Frame: 1 day ]
   preparation completion rate is the number of patients ingest more than 80% 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 18-65.
• 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

China

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

More Information

• 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: January 11, 2022
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhaoshen Li, Changhai Hospital:

Bowel preparation; Polyp; adenoma

Additional relevant MeSH terms:

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms