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

Dietary Modification Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665157
• Other study ID #: NTUH201109018RD
• Status: Completed
• Phase: N/A
• First received: February 27, 2012
• Last updated: February 18, 2014
• Start date: November 2011
• Est. completion date: June 2012

Study information

• Verified date: February 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Dietary Modification

Intervention

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:
• Self-controlled diet
Self-controlled low residue diet.

Drug:
• 2L PEG-ELS
Normal volume of PEG-ELS
• low volume 1.5L PEG-ELS
Low volume PEG-ELS

Locations

Country	Name	City	State
Taiwan	E-Da Hospital	Kaohsiung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	National Taiwan University Hospital Bei-Hu Branch	Taipei
Taiwan	Taipei Medical University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol	It represented the percentage of participants who is satisfied with the protocol.	1 day	No
Secondary	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	No