Prepackaged Nutritional Formulations Versus Restricted Diet for Bowel Preparation

NCT ID: NCT04776733

Last Updated: 2021-04-08

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-10-01

Brief Summary

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In order to analyze the effectiveness and patient tolerance of the two bowel preparation regimens, the investigators will compare prepackaged semisolid nutritional formulations and restricted diet. The aim was to demonstrate that prepackaged semisolid nutritional formulations is not inferior in overall quality of intestinal preparation to restricted diet in subjects undergoing colonoscopy.

Detailed Description

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Conditions

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Bowel Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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prepackaged group

All colonoscopy were performed in the afternoon. The day before the colonoscopy: 3 bags of pre-packaged food were used for diet preparation. All the patients drink single dose of 60g Polyethylene Glycol (PEG-4000) with 1L water at a rate of 250 ml every 15 min in the evening.

On the day of the colonoscopy: a bag of pre-packaged food were used for breakfast. All the patients drink single dose of 120g Polyethylene Glycol (PEG-4000) with 2L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min.

Group Type EXPERIMENTAL

prepackaged semisolid nutritional formulations

Intervention Type OTHER

The day before the colonoscopy: 3 bags of pre-packaged food were used for diet preparation.

On the day of the colonoscopy: a bag of pre-packaged food were used for breakfast.

restricted diet group

All colonoscopy were performed in the afternoon. The day before the colonoscopy: restricted diet prepared by patients were used for diet preparation. All the patients drink single dose of 60g Polyethylene Glycol (PEG-4000) with 1L water at a rate of 250 ml every 15 min in the evening.

On the day of the colonoscopy: restricted diet prepared by patients were used for breakfast. All the patients drink single dose of 120g Polyethylene Glycol (PEG-4000) with 2L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min.

Group Type ACTIVE_COMPARATOR

restricted diet

Intervention Type OTHER

The day before the colonoscopy: restricted diet prepared by patients were used for diet preparation.

On the day of the colonoscopy: restricted diet prepared by patients were used for breakfast.

Interventions

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prepackaged semisolid nutritional formulations

The day before the colonoscopy: 3 bags of pre-packaged food were used for diet preparation.

On the day of the colonoscopy: a bag of pre-packaged food were used for breakfast.

Intervention Type OTHER

restricted diet

The day before the colonoscopy: restricted diet prepared by patients were used for diet preparation.

On the day of the colonoscopy: restricted diet prepared by patients were used for breakfast.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients age between 18-75 years old requiring colonoscopy and willing to participate in this study.

Exclusion Criteria

1. Patients with constipation;
2. Patients with congestive heart failure;
3. Patients with a history of kidney disease;
4. Patients with a history of poor intestinal preparation;
5. Pregnant / lactating women;
6. Patients without informed consent;
7. Allergic or intolerant to any research drug;
8. Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis and toxic megacolon;
9. Patients with a history of inflammatory bowel disease;
10. History of colorectal resection;
11. Patients with diabetes.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ningbo No. 1 Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ningbo First Hospital

Ningbo, Zhejiang, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Lie min Ruan, MD

Role: primary

+86-574-87085111

Other Identifiers

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AHE 1.0

Identifier Type: -

Identifier Source: org_study_id

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