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

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.

Study Overview

• Status: Completed
• Conditions: Bowel Preparation for Colonoscopy
• Intervention / Treatment: Dietary supplement: Low-residue full nutrition formula podwer; Dietary supplement: Self-prepared low-residue diet

• Study Type: Interventional
• Enrollment (Actual): 757
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • East China Hospital, Fudan University
  • Shanghai, China
    • Shanghai Seventh People's Hospital
  • Anhui
    • Lu'an, Anhui, China
      • Lu'an People's Hospital
  • Fujian
    • Quanzhou, Fujian, China
      • PLA 909 Hospital
    • Zhangzhou, Fujian, China
      • PLA 909 Hospital
  • Guangdong
    • Huizhou, Guangdong, China
      • Huizhou Central People's Hospital
    • Jiangmen, Guangdong, China
      • Jiangmen Central Hospital
  • Guizhou
    • Guiyang, Guizhou, China
      • Affiliated Hospital of Guizhou Medical University
  • Hebei
    • Shijiazhuang, Hebei, China
      • The Second Hospital of Hebei Medical University
    • Zhangjiakou, Hebei, China
      • The First Affiliated Hospital of Hebei North University
  • Jiangsu
    • Nanjin, Jiangsu, China
      • Jiangsu Provincial Hospital of Traditional Chinese Medicine
    • Nanjing, Jiangsu, China
      • Jiangsu Province Hospital
    • Nanjing, Jiangsu, China
      • Nanjing Gulou Hospital
    • Wuxi, Jiangsu, China
      • Affiliated Hospital of Jiangnan University
    • Yangzhou, Jiangsu, China
      • Jiangsu Subei People's Hospital
  • Jiangxi
    • Ganzhou, Jiangxi, China
      • Ganzhou People's Hospital
    • Nanchang, Jiangxi, China
      • The Second Affiliated Hospital of Nanchang University
  • Liaoning
    • Dalian, Liaoning, China
      • the central hospital of Dalian
    • Shenyang, Liaoning, China
      • Northern Theater General Hospital
  • Shandong
    • Dongying, Shandong, China
      • Shengli Oilfield Central Hospital
    • Jinan, Shandong, China
      • Shandong Provincial Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200433
      • Changhai Hospital, Naval Medical University
    • Shanghai, Shanghai Municipality, China
      • Shanghai East Hospital
  • Shanxi
    • Ankang, Shanxi, China
      • Ankang Central Hospital
  • Sichuan
    • Yibin, Sichuan, China
      • Yibin Second People's Hospital
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • The First Affiliated Hospital of Wenzhou Medical University
    • Wenzhou, Zhejiang, China
      • The Second Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-residue nutrition formula podwer combined with 2 liters of polyethylene glycol	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.
Active Comparator: Self-prepared low-residue diet combined with 3 liters of polyethylene glycol	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Study Chair: Li Zhaoshen, PhD, Department of Gastroenterology, Changhai Hospital, Navy Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): June 20, 2025

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Bowel preparation, Low-residue diet, colonoscopy
• Other Study ID Numbers: FNFP2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No