Efficacy of Low-residue Full Nutritive Formula Powder in Bowel Preparation for Colonoscopy
NCT Number: NCT06514989
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bowel Preparation for Colonoscopy
Interventions: DIETARY_SUPPLEMENT: Low-residue full nutrition formula podwer|DIETARY_SUPPLEMENT: Self-prepared low-residue diet
Sponsor: Changhai Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 750
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-01
Completion Date: 2025-03-31
Locations: Lu'an People's Hospital, Lu'an, Anhui, China|PLA 909 Hospital, Quanzhou, Fujian, China|PLA 909 Hospital, Zhangzhou, Fujian, China|Huizhou Central People's Hospital, Huizhou, Guangdong, China|Jiangmen Central Hospital, Jiangmen, Guangdong, China|Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, China|The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China|The First Affiliated Hospital of Hebei North University, Zhangjiakou, Hebei, China|Jiangsu Province Hospital, Nanjing, Jiangsu, China|Nanjing Gulou Hospital, Nanjing, Jiangsu, China|Jiangsu Provincial Hospital of Traditional Chinese Medicine, Nanjin, Jiangsu, China|Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China|Jiangsu Subei People's Hospital, Yangzhou, Jiangsu, China|Ganzhou People's Hospital, Ganzhou, Jiangxi, China|The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China|the central hospital of Dalian, Dalian, Liaoning, China|Northern Theater General Hospital, Shenyang, Liaoning, China|Shengli Oilfield Central Hospital, Dongying, Shandong, China|Shandong Provincial Hospital, Jinan, Shandong, China|Changhai Hospital, Naval Medical University, Shanghai, Shanghai, 200433, China|Shanghai East Hospital, Shanghai, Shanghai, China|Ankang Central Hospital, Ankang, Shanxi, China|Yibin Second People's Hospital, Yibin, Sichuan, China|The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China|The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China|East China Hospital, Fudan University, Shanghai, China|Shanghai Seventh People's Hospital, Shanghai, China

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.

Primary Outcome Measures: Adequate bowel preparation rate, Defined as score ≥ 2 for all colon segment (right-side colon, transverse colon, and left-side colon) according to the Boston Bowel Preparation Scale, Two months
Secondary Outcome Measures: Excellent bowel preparation rate, Two months|BBPS score (including total score, left colon, transverse colon, and right colon), Two months|Aronchick Scale score, Two months|Bowel preparation completion rate, PEG intake is more than 90% of the requirement, Two weeks|Subject satisfaction rate, Two weeks|Colonoscopist satisfaction rate, Two weeks|Adenoma detection rate, Four weeks|Polyp detection rate, Two weeks|Compliance with FNFP, Two weeks