NCT06514989

Efficacy of Low-residue Full Nutritive Formula Powder in Bowel Preparation for Colonoscopy

Efficacy of Low-residue Full Nutritive Formula Powder in Bowel Preparation for Colonoscopy: a Multicenter Non-inferiority Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 757 (actual)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Previously, our team compared the effects of a low-residue full nutrition formula podwer (FNFP) combined with 3 liters of polyethylene glycol(PEG) solution and the self-prepared low-residue diet combined with 3 liters of PEG solution on the quality of bowel preparation for colonoscopy, and the results showed that the adequate bowel preparation rate was significantly improved in low-residue full nutrition formula podwer group. However, there are still a considerable number of patients in the process of taking 3L PEG appeared bloating, abdominal pain, nausea, vomiting and other adverse reactions, indicating some subjects can not tolerate the dosage of 3L PEG. In order to reduce adverse reactions and provide more options for people with low PEG tolerance, this study intends to compare the effects of low-residue FNFP combined with 2L PEG and self-provided low-residue diet combined with 3L PEG on the quality bowel preparation, colonoscopy lesions detection, adverse reactions, and tolerance, compliance and satisfaction of subjects.

Conditions

• Bowel Preparation for Colonoscopy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Low-residue full nutrition formula podwer	The day before the colonoscopy, subjects were given a low-residue full nutrition formula podwer instead of a traditional self-prepared low-residue diet. Subjects were given 6 packs (60g/pack) pre-packaged FNFP and asked to use the FNFP according to individual needs. The 2 liters of polyethylene glycol solution is taken in split dosing, with 1 liter taken at 8pm the day before the colonoscopy and 1 liter taken 3-5 hours before the 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. The 3 liters of polyethylene glycol solution is taken in split dosing, with 1 liter taken at 8pm the day before the colonoscopy and 2 liter taken 4-6 hours before the colonoscopy.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-03-31
• Completion: 2025-06-20
• First posted: 2024-07-23
• Last updated: 2025-09-11

Locations

27 sites across 1 country: China