Using a low-residue nutrition formula to improve bowel preparation for colonoscopy

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

This study tests if a new low-residue nutrition powder mixed with less bowel prep solution can help people get ready for a colonoscopy more comfortably and effectively than the usual method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 750 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Changhai Hospital (Academic / other)
• Locations: 27 sites (Lu'an, Anhui and 26 other locations)
• Trial ID: NCT06514989 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a low-residue full nutrition formula powder combined with a reduced volume of polyethylene glycol (PEG) solution for bowel preparation prior to colonoscopy. It aims to compare this approach with a self-prepared low-residue diet combined with a standard 3 liters of PEG solution. The focus is on improving bowel preparation quality, enhancing lesion detection during colonoscopy, and minimizing adverse reactions associated with bowel prep. The study targets patients who may struggle with the traditional PEG regimen due to tolerance issues.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 scheduled for a colonoscopy who do not have severe comorbidities or contraindications.

Not a fit: Patients with severe heart, lung, or kidney complications, recent myocardial infarction, or significant gastrointestinal issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more tolerable and effective bowel preparation method for patients undergoing colonoscopy.

How similar studies have performed: Previous studies have shown improvements in bowel preparation quality using low-residue diets, but this specific approach with a low-residue nutrition formula is relatively novel.

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.

Where this trial is running

Lu'an, Anhui and 26 other locations

• Lu'an People's Hospital — Lu'an, Anhui, China (Not_yet_recruiting)
• PLA 909 Hospital — Quanzhou, Fujian, China (Not_yet_recruiting)
• PLA 909 Hospital — Zhangzhou, Fujian, China (Not_yet_recruiting)
• Huizhou Central People's Hospital — Huizhou, Guangdong, China (Not_yet_recruiting)
• Jiangmen Central Hospital — Jiangmen, Guangdong, China (Not_yet_recruiting)
• Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China (Not_yet_recruiting)
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• The First Affiliated Hospital of Hebei North University — Zhangjiakou, Hebei, China (Not_yet_recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Nanjing Gulou Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Jiangsu Provincial Hospital of Traditional Chinese Medicine — Nanjin, Jiangsu, China (Not_yet_recruiting)
• Affiliated Hospital of Jiangnan University — Wuxi, Jiangsu, China (Not_yet_recruiting)
• Jiangsu Subei People's Hospital — Yangzhou, Jiangsu, China (Not_yet_recruiting)
• Ganzhou People's Hospital — Ganzhou, Jiangxi, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• the central hospital of Dalian — Dalian, Liaoning, China (Not_yet_recruiting)
• Northern Theater General Hospital — Shenyang, Liaoning, China (Recruiting)
• Shengli Oilfield Central Hospital — Dongying, Shandong, China (Not_yet_recruiting)
• Shandong Provincial Hospital — Jinan, Shandong, China (Not_yet_recruiting)
• Changhai Hospital, Naval Medical University — Shanghai, Shanghai, China (Recruiting)
• Shanghai East Hospital — Shanghai, Shanghai, China (Not_yet_recruiting)
• Ankang Central Hospital — Ankang, Shanxi, China (Not_yet_recruiting)
• Yibin Second People's Hospital — Yibin, Sichuan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Not_yet_recruiting)
• East China Hospital, Fudan University — Shanghai, China (Not_yet_recruiting)
• Shanghai Seventh People's Hospital — Shanghai, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Li Zhaoshen, PhD

Conditions Bowel Preparation for Colonoscopy; Bowel preparation, Low-residue diet, colonoscopy