a Low-residue Diet for Bowel Preparation

NCT03943758 | Completed DMC

• 1 other identifier: Low-residue
• Study Type: interventional
• Target: 589
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Polyp; Colorectal Adenoma

Keywords

Bowel preparation; Polyp; adenoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• adenoma detection rate (ADR)

  30 mins

• preparation completion rate

  1 day

Study Arms (2)

prepackaged Low-residue diet group

EXPERIMENTAL

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

self-prepared Low-residue group

ACTIVE COMPARATOR

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

Interventions

Prepackaged Low-residue diet DIETARY_SUPPLEMENT

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.

prepackaged Low-residue diet group

Self-prepared Low-residue diet DIETARY_SUPPLEMENT

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.

self-prepared Low-residue group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients whose age is between 18-65.
• Patients who have indications for screening, surveillance and diagnostic colonoscopy.
• Patients who have signed inform consent form

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead
• Qilu Hospital of Shandong University: collaborator
• Jinan Military General Hospital: collaborator
• Wuhan TongJi Hospital: collaborator
• Zhejiang University: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• West China Hospital: collaborator

Study Sites (1)

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

Location

Related Publications (1)

• Pan P, Gu L, Zhao S, Wang S, Ma J, Fu H, Chen Y, He S, Tian Z, Xu L, Feng Z, Li Y, Yang Z, Yang L, Wang W, Hou Q, Liu T, Li C, Tian D, Wang X, Gao Y, Shi H, Bai Y, Li Z. Prepackaged formula low-residue diet vs. self-prepared low-residue diet before colonoscopy: A multicenter randomized controlled trial. Front Med (Lausanne). 2023 Mar 24;10:1029493. doi: 10.3389/fmed.2023.1029493. eCollection 2023.

  PMID: 37035340 DERIVED

MeSH Terms

Conditions

Colonic Polyps; Polyps; Adenoma

Condition Hierarchy (Ancestors)

Intestinal Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Zhaoshen Li, M.D.

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology Dept

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 9, 2019
• Study Start: May 10, 2019
• Primary Completion: December 10, 2020
• Study Completion: December 31, 2020
• Last Updated: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)