a Low-residue Diet for Bowel Preparation

Colorectal Adenoma Clinical Trial

Official title:

Effect of a Prepackaged Low-residue Diet on Bowel Preparation for Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03943758
• Other study ID #: Low-residue
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2021
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 589
• Est. completion date: December 31, 2020
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Colon Polyp
• Colorectal Adenoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai

Sponsors (8)

Lead Sponsor	Collaborator
Changhai Hospital	First Affiliated Hospital, Sun Yat-Sen University, Jinan Military General Hospital, Qilu Hospital of Shandong University, The First Affiliated Hospital with Nanjing Medical University, West China Hospital, Wuhan TongJi Hospital, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	BBPS scores of the entire colon	The sum of the scores of three bowel segment.	30 mins
Secondary	adenoma detection rate (ADR)	adenoma detection rate is the number of patients with at least one adenoma, divided by the total number of patients.	30 mins
Secondary	preparation completion rate	preparation completion rate is the number of patients ingest more than 80% laxative, divided by the total number of patients.	1 day