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Effectiveness of Enteral Nutrition for Dose Reduction of Low Dose PEG

N

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

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

Trial contacts and locations

1

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Central trial contact

Hongpeng Lu, master; Lei Xu, PhD

Data sourced from clinicaltrials.gov

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