Effectiveness of Enteral Nutrition for Dose Reduction of Low Dose PEG
Comparison of Two Bowel Cleansing Regimens（Controlled Dietary Restriction With Enteral Nutrition and 1.5L Polyethylene Glycol vs Controlled Dietary Restriction and 2.0L Polyethylene Glycol）：an Endoscopist-blinded, Prospective Randomized Controlled Trial
1 other identifier
interventional
248
1 country
1
Brief Summary
This clinical trial is being conducted to assess whether dietary restriction with enteral nutrition prescribed could prevent nonadherence to dietary restrictions, enable additional reduction of the required volume of PEG-ELS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2019
CompletedFirst Posted
Study publicly available on registry
July 16, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedJuly 16, 2019
July 1, 2019
Same day
July 5, 2019
July 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
the quality of bowel preparation
Evaluation of the quality of bowel preparation for each participant by the Ottawa bowel preparation scale(OBPS)，it's a validated scoring system with scores between 0 and 14, where 0 is the best score，The score comprises a sub score 0-4 for each colon segment: right, transverse and rectosigmoid colon.n addition, a score 0-2 is added to indicate the total amount of luminal fluid.
1day
Secondary Outcomes (5)
patients' satisfaction with the process of bowel preparation
1day
patients' willingness to have the colonoscopy done again at this facility in the future
1day
comparison with previous experience
1day
adverse events
1day
Convenience of Protocol between enteral nutrition with low volume 1.5L PEG and Self-controlled diet with normal amount of 2L PEG Protocol
1day
Study Arms (2)
Enteral Nutritional+PEG
EXPERIMENTALEnteral Nutritional Powder with low volume 1.5L PEG
Self-controlled diet+PEG
PLACEBO COMPARATORSelf-controlled diet with normal amount of 2L PEG
Interventions
Enteral Nutrition Powder Ensure for each meal.The duration of study is one day before colonoscopy.
Eligibility Criteria
You may qualify if:
- the age of 18-75year
- Outpatients undergoing colonoscopy
- Informed consent
You may not qualify if:
- the age \>75 years or \<18 years
- history of colectomy or bowel obstruction
- severe constipation (defined as stool frequerncy of 3 or less/week)
- current pregnancy or breastfeeding
- BMI \>30, diabetes
- known allergies to cleansing agents or ingredients of Enteral nutrition
- inability to follow the oral bowel preparation regimen.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ningbo first hospital
Ningbo, Zhejiang, 315010, China
Study Officials
- PRINCIPAL INVESTIGATOR
Hongpeng Lu, master
Department of Gastroenterology, Ningbo No. 1 Hospital, Ningbo, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2019
First Posted
July 16, 2019
Study Start
August 1, 2019
Primary Completion
August 1, 2019
Study Completion
November 1, 2019
Last Updated
July 16, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share