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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Dietary Modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

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low-residue diet package (Enimaclin®)

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

Group Type EXPERIMENTAL

Enimaclin®

Intervention Type 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.

2L PEG-ELS

Intervention Type DRUG

Normal volume of PEG-ELS

Self-controlled diet

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

Group Type PLACEBO_COMPARATOR

Self-controlled diet

Intervention Type OTHER

Self-controlled low residue diet.

2L PEG-ELS

Intervention Type DRUG

Normal volume of PEG-ELS

Low-residue diet (Enimaclin®) package

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

Group Type EXPERIMENTAL

Enimaclin®

Intervention Type 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.

low volume 1.5L PEG-ELS

Intervention Type DRUG

Low volume PEG-ELS

Interventions

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Enimaclin®

Enimaclin Colomil ® (Glico Co., Japan Osaka)，a low-residue diet package for each meal.

The duration of study is one day before colonoscopy.

Intervention Type DIETARY_SUPPLEMENT

Self-controlled diet

Self-controlled low residue diet.

Intervention Type OTHER

2L PEG-ELS

Normal volume of PEG-ELS

Intervention Type DRUG

low volume 1.5L PEG-ELS

Low volume PEG-ELS

Intervention Type DRUG

Other Intervention Names

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Enimaclin Colomil ®,a low-residue diet package Self-controlled low residue diet. Taiwan name: Niflec powder Taiwan name: Niflec powder

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No