Effectiveness of Enteral Nutrition for Dose Reduction of Low Dose PEG

Study Overview
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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.

Official Title
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Comparison of Two Bowel Cleansing Regimens（Controlled Dietary Restriction With Enteral Nutrition and 1.5L Polyethylene Glycol vs Controlled Dietary Restriction and 2.0L Polyethylene Glycol）：an Endoscopist-blinded, Prospective Randomized Controlled Trial

Conditions
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Bowel Preparation

Intervention / Treatment
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* Dietary Supplement: Enteral Nutrition Powder Ensure
* Drug: 1.5L PEG
* Other: Self-controlled diet
* Drug: 2L PEG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the age of 18-75year Outpatients undergoing colonoscopy Informed consent Exclusion Criteria: the age >75 years or <18 years history of colectomy or bowel obstruction severe constipation (defined as stool frequerncy of 3 or less/week) current pregnancy or breastfeeding BMI >30, diabetes known allergies to cleansing agents or ingredients of Enteral nutrition inability to follow the oral bowel preparation regimen.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enteral Nutritional+PEG<br>Enteral Nutritional Powder with low volume 1.5L PEG | Dietary Supplement: Enteral Nutrition Powder Ensure<br>* Enteral Nutrition Powder Ensure for each meal.The duration of study is one day before colonoscopy.<br>* Other names: Ensure;Drug: 1.5L PEG<br>* Low volume PEG<br>* Other names: Hengkangzhengqing;|
| Placebo Comparator: Self-controlled diet+PEG<br>Self-controlled diet with normal amount of 2L PEG | Other: Self-controlled diet<br>* Self-controlled low residue diet.<br>Drug: 2L PEG<br>* Normal volume of PEG<br>* Other names: Hengkangzhengqing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the quality of bowel preparation | 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. | 1day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients' satisfaction with the process of bowel preparation | 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. | 1day | 
| patients' willingness to have the colonoscopy done again at this facility in the future | 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. | 1day | 
| comparison with previous experience | 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. | 1day | 
| adverse events | It represent the incidence of abdominal cramping, bloating, nausea/vomiting after intake of PEG and/or enteral nutrition was compared. | 1day | 
| Convenience of Protocol between enteral nutrition with low volume 1.5L PEG and Self-controlled diet with normal amount of 2L PEG Protocol | It represented the percentage of patients who thinks the protocol is easy to use. | 1day |