Efficacy and Acceptability of Low-Residue Diet Package (Enimaclin®) as Diet Control Before Colonoscopy
This study is currently recruiting participants.
Verified August 2012 by National Taiwan University Hospital
Sponsor:
National Taiwan University Hospital
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01665157
First received: February 27, 2012
Last updated: August 13, 2012
Last verified: August 2012
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Purpose
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 | Intervention |
|---|---|
|
Dietary Modification |
Dietary Supplement: Enimaclin® Other: Self-controlled diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 |
Resource links provided by NLM:
Further study details as provided by National Taiwan University Hospital:
Primary Outcome Measures:
- Cleansing level at colonoscopy [ Time Frame: 1 day ] [ Designated as safety issue: No ]The level of bowel cleansing using overall and segmental four-level scales
Secondary Outcome Measures:
- Acceptability of low-residue diet package (Enimaclin®) as diet control before colonoscopy. [ Time Frame: 1 day ] [ Designated as safety issue: No ]The secondary endpoints includes acceptability of individual way of bowel preparation.
- Total volume of purgatives that ingested [ Time Frame: 1 day ] [ Designated as safety issue: No ]The total volume of PEG-ELS (mL) that ingested or could be ingested by examinee before colonoscopy
| Estimated Enrollment: | 180 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: low-residue diet package (Enimaclin®)
with normal amount of 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
|
| Placebo Comparator: Self-controlled diet |
Other: Self-controlled diet
Self-controlled low residue diet.
Other Name: Self-controlled low residue diet.
|
|
Experimental: Low-residue diet (Enimaclin®) package
with reduced volume PEG-ELS ( at least 1500mL)
|
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
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female
- Inpatient, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665157
Contacts
| Contact: Han-Mo Chiu, M.D., Ph.D. | (02)23123456 ext 65689 | hanmochiu@ntu.edu.tw |
Locations
| Taiwan | |
| E-Da Hospital | Recruiting |
| Kaohsiung, Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan | |
| Principal Investigator: Han-Mo Chiu, M.D., Ph.D. | |
| National Taiwan University Hospital Bei-Hu Branch | Recruiting |
| Taipei, Taiwan | |
| Taipei Medical University Hospital | Recruiting |
| Taipei, Taiwan | |
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
| Principal Investigator: | Han-Mo Chiu, M.D., Ph.D. | NTUH |
More Information
No publications provided
| Responsible Party: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT01665157 History of Changes |
| Other Study ID Numbers: | NTUH201109018RD |
| Study First Received: | February 27, 2012 |
| Last Updated: | August 13, 2012 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by National Taiwan University Hospital:
|
Diet Control before Colonoscopy |
Additional relevant MeSH terms:
|
Food Habits Habits |
ClinicalTrials.gov processed this record on May 23, 2013