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Completed

NCT Number: NCT01665157

Efficacy and 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.

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Key information

Conditions

Dietary Modification

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

E-Da Hospital, Kaohsiung, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enimaclin®

Dietary Supplement

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

Self-controlled diet

Other

Self-controlled low residue diet.

Other names: Self-controlled low residue diet.

2L PEG-ELS

Drug

Normal volume of PEG-ELS

Other names: Taiwan name: Niflec powder

low volume 1.5L PEG-ELS

Drug

Low volume PEG-ELS

Other names: Taiwan name: Niflec powder

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 15, 2012
Registry last updated
Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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