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

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

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

Study Overview

• Status: Completed
• Conditions: Dietary Modification
• Intervention / Treatment: Other: Self-controlled diet; Dietary supplement: Enimaclin®; Drug: 2L PEG-ELS; Drug: low volume 1.5L PEG-ELS

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • E-DA Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Taipei Medical University Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital Bei-Hu Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Han-Mo Chiu, M.D., Ph.D., NTUH

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: February 27, 2012
• First Submitted That Met QC Criteria: August 13, 2012
• First Posted (Estimate): August 15, 2012

Study Record Updates

• Last Update Posted (Estimate): April 2, 2014
• Last Update Submitted That Met QC Criteria: February 18, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Diet Control before Colonoscopy
• Other Study ID Numbers: NTUH201109018RD