Efficacy of Low-residue Full Nutritive Formula Powder in Bowel Preparation for Colonoscopy
1 other identifier
interventional
757
1 country
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2024
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2024
CompletedFirst Submitted
Initial submission to the registry
July 18, 2024
CompletedFirst Posted
Study publicly available on registry
July 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2025
CompletedSeptember 11, 2025
September 1, 2025
9 months
July 18, 2024
September 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
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
Two weeks
Subject satisfaction rate
Two weeks
- +4 more secondary outcomes
Study Arms (2)
Low-residue nutrition formula podwer combined with 2 liters of polyethylene glycol
EXPERIMENTALSelf-prepared low-residue diet combined with 3 liters of polyethylene glycol
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- adult subjects between the ages of 18 and 75 who were scheduled for screening, monitoring, and diagnostic colonoscopy.
You may not qualify if:
- severe heart, brain, lung, kidney complications or a history of acute myocardial infarction within six months.
- a history of abdominal or pelvic surgery, BMI \> 28 or BMI \< 18.5, inflammatory bowel disease, constipation (less than 3 bowel movements in the past week, with strenuous bowel movements, hard stool, small volume), or intestinal obstruction.
- imaging and laboratory tests are highly suspicious of colorectal cancer or warning signs and symptoms of colorectal cancer: blood in the stool, black stool, unexplained anemia and significant weight loss, abdominal mass, and positive digital rectal examination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
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 Provincial Hospital of Traditional Chinese Medicine
Nanjin, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nanjing Gulou Hospital
Nanjing, 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 Municipality, 200433, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 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
Study Officials
- STUDY CHAIR
Li Zhaoshen, PhD
Department of Gastroenterology, Changhai Hospital, Navy Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Department of Gastroenterology, the First Affiliated Hospital of Naval Medical University
Study Record Dates
First Submitted
July 18, 2024
First Posted
July 23, 2024
Study Start
July 1, 2024
Primary Completion
March 31, 2025
Study Completion
June 20, 2025
Last Updated
September 11, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share