Effectiveness of Enteral Nutrition for Dose Reduction of Low Dose PEG

NCT ID: NCT04021979

Last Updated: 2019-07-16

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

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2019-11-01

Brief Summary

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This clinical trial is being conducted to assess whether dietary restriction with enteral nutrition prescribed could prevent nonadherence to dietary restrictions, enable additional reduction of the required volume of PEG-ELS.

Detailed Description

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Bowel preparation plays a vital role in the quality of colonoscopy.Bowel preparation consists of 2 key steps: dietary restriction and purgative ingestion.Two liters of PEG-ELS are widely used in Asian countries, but in a well-designed clinical trial,additional reduction of PEG-ELS volume seems feasible. Enteral nutrition may simplify the process and avoid unexpected intake of fiber-containing food.

We hypothesized that dietary restriction with enteral nutrition prescribed could prevent nonadherence to dietary restrictions, enable additional reduction of the required volume of PEG-ELS.

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

SINGLE

Investigators

Study Groups

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Enteral Nutritional+PEG

Enteral Nutritional Powder with low volume 1.5L PEG

Group Type EXPERIMENTAL

Enteral Nutrition Powder Ensure

Intervention Type DIETARY_SUPPLEMENT

Enteral Nutrition Powder Ensure for each meal.The duration of study is one day before colonoscopy.

1.5L PEG

Intervention Type DRUG

Low volume PEG

Self-controlled diet+PEG

Self-controlled diet with normal amount of 2L PEG

Group Type PLACEBO_COMPARATOR

Self-controlled diet

Intervention Type OTHER

Self-controlled low residue diet.

2L PEG

Intervention Type DRUG

Normal volume of PEG

Interventions

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Enteral Nutrition Powder Ensure

Enteral Nutrition Powder Ensure for each meal.The duration of study is one day before colonoscopy.

Intervention Type DIETARY_SUPPLEMENT

1.5L PEG

Low volume PEG

Intervention Type DRUG

Self-controlled diet

Self-controlled low residue diet.

Intervention Type OTHER

2L PEG

Normal volume of PEG

Intervention Type DRUG

Other Intervention Names

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Ensure Hengkangzhengqing Hengkangzhengqing

Eligibility Criteria

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Inclusion Criteria

1. the age of 18-75year
2. Outpatients undergoing colonoscopy
3. Informed consent

Exclusion Criteria

1. the age \>75 years or \<18 years
2. history of colectomy or bowel obstruction
3. severe constipation (defined as stool frequerncy of 3 or less/week)
4. current pregnancy or breastfeeding
5. BMI \>30, diabetes
6. known allergies to cleansing agents or ingredients of Enteral nutrition
7. inability to follow the oral bowel preparation regimen.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ningbo No. 1 Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongpeng Lu, master

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, Ningbo No. 1 Hospital, Ningbo, China

Locations

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Ningbo first hospital

Ningbo, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Lei Xu, PhD

Role: CONTACT

+86-0574-87089840

Hongpeng Lu, master

Role: CONTACT

+86-0574-87089848

Other Identifiers

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2017-R035

Identifier Type: -

Identifier Source: org_study_id

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