Dietary ModificationNCT01665157
Efficacy and Acceptability of Low-Residue Diet Package (Enimaclin®) as Diet Control Before Colonoscopy
A study testing Enimaclin®, 2L PEG-ELS and low volume 1.5L PEG-ELS in people with Dietary Modification, run by National Taiwan University Hospital at 4 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Dietary Modification
- What is being tested?
- Enimaclin®, 2L PEG-ELS and low volume 1.5L PEG-ELS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 4 sitesTaiwan
- Study dates
- Nov 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Outpatient or healthy volunteer for health examination, 20~75 years old
- Eligible for oral bowel preparation
- BMI (Body Mass Index) ≤ 30
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Taiwan4 sites
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
About this study
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
The purpose of this study is to evaluate the efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control before colonoscopy.
Read the 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.
- Conditions
- Dietary Modification
- Being tested
- Enimaclin®, Self-controlled diet, 2L PEG-ELS, low volume 1.5L PEG-ELS
- Keywords
- Diet Control before Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enimaclin®Dietary supplement
Also called Enimaclin Colomil ®,a low-residue diet package
Enimaclin Colomil ® (Glico Co., Japan Osaka)，a low-residue diet package for each meal.
The duration of study is one day before colonoscopy.
Self-controlled dietOther
Also called Self-controlled low residue diet.
Self-controlled low residue diet.
2L PEG-ELSDrug
Also called Taiwan name: Niflec powder
Normal volume of PEG-ELS
low volume 1.5L PEG-ELSDrug
Also called Taiwan name: Niflec powder
Low volume PEG-ELS
| Study group | Role | What they receive |
|---|---|---|
| low-residue diet package (Enimaclin®) | Experimental | Low-residue diet package with normal amount 2L PEG-ELS Receives: Dietary Supplement: Enimaclin®; Drug: 2L PEG-ELS |
| Self-controlled diet | Placebo comparator | Self-controlled diet with normal amount of 2L PEG-ELS Receives: 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 Receives: Dietary Supplement: Enimaclin®; Drug: low volume 1.5L PEG-ELS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 1 day
Secondary outcomes (3)
Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol
It represent the proportion of participants who wanted to choose the same protocol as they received in this trial.
Measured: 1 day
Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol
It represented the percentage of participants who is satisfied with the protocol.
Measured: 1 day
Convenience of Different Low Residual Diet and Bowel Preparation Protocol
It represented the percentage of participants who thinks the protocol is easy to use.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startNov 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Han-Mo Chiu, M.D., Ph.D., Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665157
- Sponsor's protocol ID
- NTUH201109018RD
- Status last verified
- Feb 2014
- First submitted
- 27 Feb 2012
- Last updated
- 2 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01665157
- Acronym / sponsor ID
- NTUH201109018RD
- Conditions
- Dietary Modification
- Keywords
- Diet Control before Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Aug 2012 (estimated)
- Results
- Posted 6 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control before colonoscopy.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low-residue diet package (Enimaclin®) | Experimental | Dietary Supplement: Enimaclin®, Drug: 2L PEG-ELSLow-residue diet package with normal amount 2L PEG-ELS |
| Self-controlled diet | Placebo comparator | Other: Self-controlled diet, Drug: 2L PEG-ELSSelf-controlled diet with normal amount of 2L PEG-ELS |
| Low-residue diet (Enimaclin®) package | Experimental | Dietary Supplement: Enimaclin®, Drug: low volume 1.5L PEG-ELSLow-residue diet package with low volume 1.5L PEG-ELS |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female
- Outpatient or healthy volunteer for health examination, 20~75 years old
- Eligible for oral bowel preparation
- BMI (Body Mass Index) ≤ 30
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enimaclin®Also: Enimaclin Colomil ®,a low-residue diet packageEnimaclin Colomil ® (Glico Co., Japan Osaka)，a low-residue diet package for each meal. The duration of study is one day before colonoscopy. | Dietary supplement | Low-residue diet (Enimaclin®) package, low-residue diet package (Enimaclin®) |
| Self-controlled dietAlso: Self-controlled low residue diet.Self-controlled low residue diet. | Other | Self-controlled diet |
| 2L PEG-ELSAlso: Taiwan name: Niflec powderNormal volume of PEG-ELS | Drug | Self-controlled diet, low-residue diet package (Enimaclin®) |
| low volume 1.5L PEG-ELSAlso: Taiwan name: Niflec powderLow volume PEG-ELS | Drug | Low-residue diet (Enimaclin®) package |
Primary outcome
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.
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
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
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.
3 secondary outcomes
Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol
Time frame: 1 day
Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol
Time frame: 1 day
Convenience of Different Low Residual Diet and Bowel Preparation Protocol
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han-Mo Chiu, M.D., Ph.D. principal investigator
NTUH
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enimaclin®, 2L PEG-ELS and low volume 1.5L PEG-ELS in people with Dietary Modification, run by National Taiwan University Hospital at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2014.