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Completed

NCT Number: NCT06514989

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

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.

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Key information

Conditions

Bowel Preparation for Colonoscopy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lu'an People's Hospital, Lu'an, Anhui, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-residue full nutrition formula podwer

Dietary Supplement

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.

Self-prepared Low-residue diet

Dietary Supplement

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.

Primary outcomes

  1. Adequate bowel preparation rate

    Time frame: Two months

    Defined as score ≥ 2 for all colon segment (right-side colon, transverse colon, and left-side colon) according to the Boston Bowel Preparation Scale

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

    Time frame: Two weeks

    PEG intake is more than 90% of the requirement

  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

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2024
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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