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

• 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: National Taiwan University Hospital
• Information provided by (Responsible Party): National Taiwan University Hospital

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	Phase
Dietary Modification	Dietary Supplement: Enimaclin®; Other: Self-controlled diet; Drug: 2L PEG-ELS; Drug: low volume 1.5L PEG-ELS	Not Applicable

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
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: June 2012

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

• Ages Eligible for Study: 20 Years to 75 Years (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: NTUH201109018RD
• First Posted: August 15, 2012
• 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