Effectiveness of Enteral Nutrition for Dose Reduction of Low Dose PEG

Ningbo No. 1 Hospital

Status: Unknown

Conditions: Bowel Preparation

Treatments: Other: Self-controlled diet; Drug: 1.5L PEG; Dietary Supplement: Enteral Nutrition Powder Ensure; Drug: 2L PEG

Study type: Interventional

Funder types: Other

Identifiers

NCT04021979

2017-R035

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 248 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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248 participants in 2 patient groups, including a placebo group

Enteral Nutritional+PEG

Experimental group

Description:

Enteral Nutritional Powder with low volume 1.5L PEG

Treatment:

Dietary Supplement: Enteral Nutrition Powder Ensure

Drug: 1.5L PEG

Self-controlled diet+PEG

Placebo Comparator group

Description:

Self-controlled diet with normal amount of 2L PEG

Treatment:

Drug: 2L PEG

Other: Self-controlled diet