NCT03943758

a Low-residue Diet for Bowel Preparation

Completed NA Last updated 11 January 2022

What this trial tests

NA trial testing Prepackaged Low-residue diet in Colon Polyp in 589 participants. Completed in 31 December 2020.

Timeline

10 May 2019

Primary endpoint
10 December 2020

31 December 2020

Quick facts

Lead sponsor	Changhai Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	diagnostic
Enrollment	589
Start date	10 May 2019
Primary completion	10 December 2020
Estimated completion	31 December 2020
Sites	1 location across China

Drugs / interventions tested

• Prepackaged Low-residue diet
• Self-prepared Low-residue diet

Conditions studied

• Colon Polyp — all drugs for Colon Polyp →
• Colorectal Adenoma — all drugs for Colorectal Adenoma →

Sponsor

Changhai Hospital

Who can join

Adults 18 to 65, any sex, with Colon Polyp or Colorectal Adenoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Prepackaged formula low-residue diet vs. self-prepared low-residue diet before colonoscopy: A multicenter randomized controlled trial.
   Pan P, Gu L, Zhao S, Wang S, et al · · 2023 · cited 4× · PMID 37035340 · DOI 10.3389/fmed.2023.1029493