Clinical trial NCT06514989: Efficacy of Low-residue Full Nutritive Formula Powder in Bowel Preparation for Colonoscopy
Official title: Efficacy of Low-residue Full Nutritive Formula Powder in Bowel Preparation for Colonoscopy: a Multicenter Non-inferiority Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bowel Preparation for Colonoscopy
Keywords: Bowel preparation, Low-residue diet, colonoscopy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* adult subjects between the ages of 18 and 75 who were scheduled for screening, monitoring, and diagnostic colonoscopy.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Adequate bowel preparation rate
timeFrame: Two months
Secondary outcomes:
measure: Excellent bowel preparation rate
timeFrame: Two months
measure: BBPS score (including total score, left colon, transverse colon, and right colon)
timeFrame: Two months
measure: Aronchick Scale score
timeFrame: Two months
measure: Bowel preparation completion rate
timeFrame: Two weeks
measure: Subject satisfaction rate
timeFrame: Two weeks
measure: Colonoscopist satisfaction rate
timeFrame: Two weeks
measure: Adenoma detection rate
timeFrame: Four weeks
measure: Polyp detection rate
timeFrame: Two weeks
measure: Compliance with FNFP
timeFrame: Two weeks
Other outcomes:
Locations:
city: Lu'an
country: China
facility: Lu'an People's Hospital
state: Anhui
city: Quanzhou
country: China
facility: PLA 909 Hospital
state: Fujian
city: Zhangzhou
country: China
facility: PLA 909 Hospital
state: Fujian
city: Huizhou
country: China
facility: Huizhou Central People's Hospital
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
state: Guangdong
city: Guiyang
country: China
facility: Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Zhangjiakou
country: China
facility: The First Affiliated Hospital of Hebei North University
state: Hebei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Gulou Hospital
state: Jiangsu
city: Nanjin
country: China
facility: Jiangsu Provincial Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
state: Jiangsu
city: Yangzhou
country: China
facility: Jiangsu Subei People's Hospital
state: Jiangsu
city: Ganzhou
country: China
facility: Ganzhou People's Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Dalian
country: China
facility: the central hospital of Dalian
state: Liaoning
city: Shenyang
country: China
facility: Northern Theater General Hospital
state: Liaoning
city: Dongying
country: China
facility: Shengli Oilfield Central Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Shanghai
country: China
facility: Changhai Hospital, Naval Medical University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Ankang
country: China
facility: Ankang Central Hospital
state: Shanxi
city: Yibin
country: China
facility: Yibin Second People's Hospital
state: Sichuan
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Shanghai
country: China
facility: East China Hospital, Fudan University
city: Shanghai
country: China
facility: Shanghai Seventh People's Hospital
Study officials:
affiliation: Department of Gastroenterology, Changhai Hospital, Navy Medical University
name: Li Zhaoshen, PhD
role: STUDY_CHAIR
References: