Efficacy and Acceptability of Low-Residue Diet Package (Enimaclin®) as Diet Control Before Colonoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control before colonoscopy.

Detailed Description
-----------------
In this study, we investigate a randomized, single-blinded, comparative study to evaluate the efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control before colonoscopy.

Official Title
-----------------
A Randomized, Single-blinded, Comparative Study to Evaluate the Efficacy and the Acceptability of Low-residue Diet Package (Enimaclin®) as Diet Control Before Colonoscopy

Conditions
-----------------
Dietary Modification

Intervention / Treatment
-----------------
* Dietary Supplement: Enimaclin®
* Other: Self-controlled diet
* Drug: 2L PEG-ELS
* Drug: low volume 1.5L PEG-ELS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Outpatient or healthy volunteer for health examination, 20 75 years old Eligible for oral bowel preparation BMI (Body Mass Index) ≤ 30 Exclusion Criteria: Patients with severe constipation (as fewer than three stools per week) Patients with bowel obstruction Patients contraindicated with treatment drug Patients who need emergency medication Ineligible for bowel preparation Pregnant or breast-feeding Patients with known allergies to treatment drug or low-residue diet package Patients who are ineligible to enroll

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low-residue diet package (Enimaclin®)<br>Low-residue diet package with normal amount 2L PEG-ELS | Dietary Supplement: Enimaclin®<br>* Enimaclin Colomil ® (Glico Co., Japan Osaka)，a low-residue diet package for each meal. The duration of study is one day before colonoscopy.<br>* Other names: Enimaclin Colomil ®,a low-residue diet package;Drug: 2L PEG-ELS<br>* Normal volume of PEG-ELS<br>* Other names: Taiwan name: Niflec powder;|
| Placebo Comparator: Self-controlled diet<br>Self-controlled diet with normal amount of 2L PEG-ELS | Other: Self-controlled diet<br>* Self-controlled low residue diet.<br>* Other names: Self-controlled low residue diet.;Drug: 2L PEG-ELS<br>* Normal volume of PEG-ELS<br>* Other names: Taiwan name: Niflec powder;|
| Experimental: Low-residue diet (Enimaclin®) package<br>Low-residue diet package with low volume 1.5L PEG-ELS | Dietary Supplement: Enimaclin®<br>* Enimaclin Colomil ® (Glico Co., Japan Osaka)，a low-residue diet package for each meal. The duration of study is one day before colonoscopy.<br>* Other names: Enimaclin Colomil ®,a low-residue diet package;Drug: low volume 1.5L PEG-ELS<br>* Low volume PEG-ELS<br>* Other names: Taiwan name: Niflec powder;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale | Ottawa preparation scale: Colon is defined into 3 segments: Right(cecum, ascending), mid(transverse, descending), rectosigmoid. Each is scored from 0 to 4, 0 is best and 4 is worst. Fluid quantity of whole is scored as 0, small; 1, moderate; 2 large amount. The scale will be summation of the clearness of 3 segments of colon and overall fluid quantity. It ranged from 0 to 14, 0 is the most clean colon and 14 is the most dirty one. Segment score will be analyzed separately as continuous variable. | 1 day | 
| Overall Cleansing Level at Colonoscopy by Aronchick Scale | The overall proportion of participants scored as Excellent or Good by Aronchick scale. Description of Aronchick scale:It categorized colon cleansing into 5 level: Excellent, good, fair, poor, inadequate. It is categorical and cannot be summed. We will present | 1 day | 
| Total Volume of Purgatives That Ingested | The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy | 1 day | 
| Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure) | Segmental score of Ottawa bowel preparation scale was analyzed. The proportion of right segment preparation failure, defined as segmental score as 3 poor or 4 inadequate, was presented. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol | It represent the proportion of participants who wanted to choose the same protocol as they received in this trial. | 1 day | 
| Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol | It represented the percentage of participants who is satisfied with the protocol. | 1 day | 
| Convenience of Different Low Residual Diet and Bowel Preparation Protocol | It represented the percentage of participants who thinks the protocol is easy to use. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diet Control before Colonoscopy