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

National Taiwan University

Status: Completed

Conditions: Dietary Modification

Treatments: Other: Self-controlled diet; Drug: low volume 1.5L PEG-ELS; Drug: 2L PEG-ELS; Dietary Supplement: Enimaclin®

Study type: Interventional

Funder types: Other

Identifiers

NCT01665157

NTUH201109018RD

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control before colonoscopy.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

180 participants in 3 patient groups, including a placebo group

low-residue diet package (Enimaclin®)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Enimaclin®

Drug: 2L PEG-ELS

Self-controlled diet

Placebo Comparator group

Description:

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

Treatment:

Drug: 2L PEG-ELS

Other: Self-controlled diet

Low-residue diet (Enimaclin®) package

Experimental group

Description:

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

Treatment:

Dietary Supplement: Enimaclin®

Drug: low volume 1.5L PEG-ELS