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

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ClinicalTrials.gov Identifier: NCT01665157
Recruitment Status : Completed
First Posted : August 15, 2012
Results First Posted : February 6, 2014
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Dietary Modification Dietary Supplement: Enimaclin® Other: Self-controlled diet 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : November 2011
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arms and Interventions

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 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


Outcome Measures

Primary Outcome Measures :
  1. Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale [ Time Frame: 1 day ]
    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.

  2. Overall Cleansing Level at Colonoscopy by Aronchick Scale [ Time Frame: 1 day ]

    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


  3. Total Volume of Purgatives That Ingested [ Time Frame: 1 day ]
    The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy

  4. Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure) [ Time Frame: 1 day ]
    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 :
  1. Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol [ Time Frame: 1 day ]
    It represent the proportion of participants who wanted to choose the same protocol as they received in this trial.

  2. Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol [ Time Frame: 1 day ]
    It represented the percentage of participants who is satisfied with the protocol.

  3. Convenience of Different Low Residual Diet and Bowel Preparation Protocol [ Time Frame: 1 day ]
    It represented the percentage of participants who thinks the protocol is easy to use.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665157


Locations
Taiwan
E-Da Hospital
Kaohsiung, Taiwan
National Taiwan University Hospital Bei-Hu Branch
Taipei, Taiwan
National Taiwan University Hospital
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

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01665157     History of Changes
Other Study ID Numbers: NTUH201109018RD
First Posted: August 15, 2012    Key Record Dates
Results First Posted: February 6, 2014
Last Update Posted: April 2, 2014
Last Verified: February 2014

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