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

NCT01665157 | Completed Results DMC

• 1 other identifier: NTUH201109018RD
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 4

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.

Conditions

Dietary Modification

Keywords

Diet Control before Colonoscopy

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (3)

• Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol

  1 day

• Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol

  1 day

• Convenience of Different Low Residual Diet and Bowel Preparation Protocol

  1 day

Study Arms (3)

low-residue diet package (Enimaclin®)

EXPERIMENTAL

Low-residue diet package with normal amount 2L PEG-ELS

Dietary Supplement: Enimaclin®; Drug: 2L PEG-ELS

Self-controlled diet

PLACEBO COMPARATOR

Self-controlled diet with normal amount of 2L PEG-ELS

Other: Self-controlled diet; Drug: 2L PEG-ELS

Low-residue diet (Enimaclin®) package

EXPERIMENTAL

Low-residue diet package with low volume 1.5L PEG-ELS

Dietary Supplement: Enimaclin®; Drug: low volume 1.5L PEG-ELS

Interventions

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.

Also known as: Enimaclin Colomil ®,a low-residue diet package

Low-residue diet (Enimaclin®) package; low-residue diet package (Enimaclin®)

Self-controlled diet OTHER

Self-controlled low residue diet.

Also known as: Self-controlled low residue diet.

Self-controlled diet

2L PEG-ELS DRUG

Normal volume of PEG-ELS

Also known as: Taiwan name: Niflec powder

Self-controlled diet; low-residue diet package (Enimaclin®)

low volume 1.5L PEG-ELS DRUG

Low volume PEG-ELS

Also known as: Taiwan name: Niflec powder

Low-residue diet (Enimaclin®) package

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Outpatient or healthy volunteer for health examination, 20\~75 years old
• Eligible for oral bowel preparation
• BMI (Body Mass Index) ≤ 30

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (4)

E-Da Hospital

Kaohsiung, Taiwan, Taiwan

Location

National Taiwan University Hospital Bei-Hu Branch

Taipei, Taiwan, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Location

Taipei Medical University Hospital

Taipei, Taiwan, Taiwan

Location

Results Point of Contact

• Title: Han-Mo Chiu, M.D., Ph.D.
• Organization: National Taiwan University Hospital

hanmochiu@ntu.edu.tw

Study Officials

• Han-Mo Chiu, M.D., Ph.D.

  NTUH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: August 15, 2012
• Study Start: November 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 2, 2014
• Results First Posted: February 6, 2014

Record last verified: 2014-02

Locations

TW (4)