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CompletedNCT06514989Updated Sep 11, 2025

Efficacy of Low-residue Full Nutritive Formula Powder in Bowel Preparation for Colonoscopy

An interventional study of Low-residue full nutrition formula podwer and Self-prepared low-residue diet in Bowel Preparation for Colonoscopy, sponsored by Changhai Hospital. Completed at 27 sites in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-11.

Sponsored by Changhai Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
757
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bowel Preparation for Colonoscopy

Keywords

  • Bowel preparation, Low-residue diet, colonoscopy
03

In context

Lead sponsor

Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
757 participants (actual)

Study arms

  • Experimental
    Low-residue nutrition formula podwer combined with 2 liters of polyethylene glycol

    Dietary Supplement: Low-residue full nutrition formula podwer

  • Active comparator
    Self-prepared low-residue diet combined with 3 liters of polyethylene glycol

    Dietary Supplement: Self-prepared low-residue diet

Interventions

  • Dietary supplementLow-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.

  • Dietary supplementSelf-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.

06

What researchers measure

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

    Time frame: Two months

Secondary outcomes

  1. Excellent bowel preparation rate

    Time frame: Two months

  2. BBPS score (including total score, left colon, transverse colon, and right colon)

    Time frame: Two months

  3. Aronchick Scale score

    Time frame: Two months

  4. Bowel preparation completion rate

    PEG intake is more than 90% of the requirement

    Time frame: Two weeks

  5. Subject satisfaction rate

    Time frame: Two weeks

  6. Colonoscopist satisfaction rate

    Time frame: Two weeks

  7. Adenoma detection rate

    Time frame: Four weeks

  8. Polyp detection rate

    Time frame: Two weeks

  9. Compliance with FNFP

    Time frame: Two weeks

07

Study locations

27 sites
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06514989
Lead sponsor
Changhai Hospital
Responsible party
Zhaoshen Li (Director of the Department of Gastroenterology, the First Affiliated Hospital of Naval Medical University, Changhai Hospital) — Principal investigator
First posted
Jul 23, 2024
Start date
Jul 1, 2024
Primary completion
Mar 31, 2025
Completion
Jun 20, 2025
Last update
Sep 11, 2025

Study contacts

Li Zhaoshen, PhD
study chair · Department of Gastroenterology, Changhai Hospital, Navy Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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