Effectiveness of Enteral Nutrition for Dose Reduction of Low Dose PEG

Not Applicable

• Conditions: Bowel Preparation
• Interventions: Dietary Supplement: Enteral Nutrition Powder Ensure; Other: Self-controlled diet; Drug: 2L PEG; Drug: 1.5L PEG

• Registration Number: NCT04021979
• Lead Sponsor: Ningbo No. 1 Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-05
• Study First Submitted QC: 2019-07-14
• Last Update Submitted: 2019-07-14
• Study First Posted: 2019-07-16
• Last Update Posted: 2019-07-16
• Study Start: 2019-08-01
• Primary Completion: 2019-08-01
• Study Completion: 2019-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 248

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-controlled diet+PEG	2L PEG	Self-controlled diet with normal amount of 2L PEG
Enteral Nutritional+PEG	Enteral Nutrition Powder Ensure	Enteral Nutritional Powder with low volume 1.5L PEG
Self-controlled diet+PEG	Self-controlled diet	Self-controlled diet with normal amount of 2L PEG
Enteral Nutritional+PEG	1.5L PEG	Enteral Nutritional Powder with low volume 1.5L PEG

Primary Outcome Measures

Name	Time	Method
the quality of bowel preparation	1day	Evaluation of the quality of bowel preparation for each participant by the Ottawa bowel preparation scale(OBPS)，it's a validated scoring system with scores between 0 and 14, where 0 is the best score，The score comprises a sub score 0-4 for each colon segment: right, transverse and rectosigmoid colon.n addition, a score 0-2 is added to indicate the total amount of luminal fluid.

Secondary Outcome Measures

Name	Time	Method
adverse events	1day	It represent the incidence of abdominal cramping, bloating, nausea/vomiting after intake of PEG and/or enteral nutrition was compared.
patients' satisfaction with the process of bowel preparation	1day	At the end of the procedure, the patients were asked about the satisfaction with the process of bowel preparation. Satisfaction includes bad，not so bad and good.Bad means that the patient is not satisfied with the program, not so bad means that the patient is satisfied with the plan, and good means that the patient is very satisfied with the plan.
Convenience of Protocol between enteral nutrition with low volume 1.5L PEG and Self-controlled diet with normal amount of 2L PEG Protocol	1day	It represented the percentage of patients who thinks the protocol is easy to use.
patients' willingness to have the colonoscopy done again at this facility in the future	1day	It represent participants who wanted to choose the same protocol in the future as they received in this trial.Including yes and no two options, if yes, indicating that the patient is willing to undergo colonoscopy again, if no, indicating that the patient is reluctant to undergo colonoscopy again.
comparison with previous experience	1day	If patients with colonoscopy times ≥ 2, they need to compare with previous experience，Including better than last experience, similar to the last experience, and worse than the last experience.

Trial Locations

Locations (1)

Ningbo first hospital; 🇨🇳 Ningbo, Zhejiang, China