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

NCT ID: NCT06514989

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

757 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-06-20

Brief Summary

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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.

Detailed Description

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Conditions

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Bowel Preparation for Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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

Group Type EXPERIMENTAL

Low-residue full nutrition formula podwer

Intervention Type 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 combined with 3 liters of polyethylene glycol

Group Type ACTIVE_COMPARATOR

Self-prepared low-residue diet

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

Director of the Department of Gastroenterology, the First Affiliated Hospital of Naval Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Zhaoshen, PhD

Role: STUDY_CHAIR

Department of Gastroenterology, Changhai Hospital, Navy Medical University

Locations

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Lu'an People's Hospital

Lu'an, Anhui, China

Site Status

PLA 909 Hospital

Quanzhou, Fujian, China

Site Status

PLA 909 Hospital

Zhangzhou, Fujian, China

Site Status

Huizhou Central People's Hospital

Huizhou, Guangdong, China

Site Status

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Site Status

Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Site Status

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

The First Affiliated Hospital of Hebei North University

Zhangjiakou, Hebei, China

Site Status

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Nanjin, Jiangsu, China

Site Status

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status

Nanjing Gulou Hospital

Nanjing, Jiangsu, China

Site Status

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Site Status

Jiangsu Subei People's Hospital

Yangzhou, Jiangsu, China

Site Status

Ganzhou People's Hospital

Ganzhou, Jiangxi, China

Site Status

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status

the central hospital of Dalian

Dalian, Liaoning, China

Site Status

Northern Theater General Hospital

Shenyang, Liaoning, China

Site Status

Shengli Oilfield Central Hospital

Dongying, Shandong, China

Site Status

Shandong Provincial Hospital

Jinan, Shandong, China

Site Status

Changhai Hospital, Naval Medical University

Shanghai, Shanghai Municipality, China

Site Status

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Site Status

Ankang Central Hospital

Ankang, Shanxi, China

Site Status

Yibin Second People's Hospital

Yibin, Sichuan, China

Site Status

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status

East China Hospital, Fudan University

Shanghai, , China

Site Status

Shanghai Seventh People's Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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FNFP2024

Identifier Type: -

Identifier Source: org_study_id

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