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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01665157
First received: February 27, 2012
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Dietary Modification
Dietary Supplement: Enimaclin®
Other: Self-controlled diet
Drug: 2L PEG-ELS
Drug: low volume 1.5L PEG-ELS

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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.

  • Overall Cleansing Level at Colonoscopy by Aronchick Scale [ Time Frame: 1 day ] [ Designated as safety issue: No ]

    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


  • Total Volume of Purgatives That Ingested [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy

  • Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    It represent the proportion of participants who wanted to choose the same protocol as they received in this trial.

  • Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    It represented the percentage of participants who is satisfied with the protocol.

  • Convenience of Different Low Residual Diet and Bowel Preparation Protocol [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    It represented the percentage of participants who thinks the protocol is easy to use.


Enrollment: 180
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Enimaclin Colomil ®,a low-residue diet package
Drug: 2L PEG-ELS
Normal volume of PEG-ELS
Other Name: 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 Name: Self-controlled low residue diet.
Drug: 2L PEG-ELS
Normal volume of PEG-ELS
Other Name: 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 Name: Enimaclin Colomil ®,a low-residue diet package
Drug: low volume 1.5L PEG-ELS
Low volume PEG-ELS
Other Name: Taiwan name: Niflec powder

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665157

Locations
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, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Han-Mo Chiu, M.D., Ph.D. NTUH
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01665157     History of Changes
Other Study ID Numbers: NTUH201109018RD
Study First Received: February 27, 2012
Results First Received: February 21, 2013
Last Updated: February 18, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Diet Control before Colonoscopy

Additional relevant MeSH terms:
Food Habits
Habits

ClinicalTrials.gov processed this record on July 20, 2014