N/A
N=180
Efficacy and Acceptability of Low-Residue Diet Package (Enimaclin®) as Diet Control Before Colonoscopy
Dietary Modification
Bottom Line
View on ClinicalTrials.gov: NCT01665157 ↗Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale — 2.58; 3.22; 2.97 units on a scale — p=0.435
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enimaclin® (Dietary_supplement); Self-controlled diet (Other); 2L PEG-ELS (Drug); low volume 1.5L PEG-ELS (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- National Taiwan University Hospital
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale |
2.58; 3.22; 2.97 | 0.435 |
| PRIMARY Overall Cleansing Level at Colonoscopy by Aronchick Scale |
91.7; 76.7; 78.3 | 0.046 sig |
| PRIMARY Total Volume of Purgatives That Ingested |
1.96; 1.98; 1.61 | — |
| PRIMARY Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure) |
1.7; 15.0; 6.7 | 0.025 sig |
| SECONDARY Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol |
93.3; 90.0; 95.0 | — |
| SECONDARY Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol |
73.3; 36.7; 76.7 | <0.01 sig |
| SECONDARY Convenience of Different Low Residual Diet and Bowel Preparation Protocol |
88.3; 76.7; 93.3 | <0.01 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01665157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.