Effectiveness of Enteral Nutrition for Dose Reduction of Low Dose PEG

Bowel Preparation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04021979
• Other study ID #: 2017-R035
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: July 2019
• Source: Ningbo No. 1 Hospital
• Contact: Lei Xu, PhD
• Phone: +86-0574-87089840
• Email: xulei22[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Bowel preparation plays a vital role in the quality of colonoscopy.Bowel preparation consists of 2 key steps: dietary restriction and purgative ingestion.Two liters of PEG-ELS are widely used in Asian countries, but in a well-designed clinical trial，additional reduction of PEG-ELS volume seems feasible. Enteral nutrition may simplify the process and avoid unexpected intake of fiber-containing food.

We hypothesized that dietary restriction with enteral nutrition prescribed could prevent nonadherence to dietary restrictions, enable additional reduction of the required volume of PEG-ELS.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 248
• Est. completion date: November 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. the age of 18-75year

2. Outpatients undergoing colonoscopy

3. Informed consent

Exclusion Criteria:

1. the age >75 years or <18 years

2. history of colectomy or bowel obstruction

3. severe constipation (defined as stool frequerncy of 3 or less/week)

4. current pregnancy or breastfeeding

5. BMI >30, diabetes

6. known allergies to cleansing agents or ingredients of Enteral nutrition

7. inability to follow the oral bowel preparation regimen.

Related Conditions & MeSH terms

• Bowel Preparation

Intervention

Dietary Supplement:
• Enteral Nutrition Powder Ensure
Enteral Nutrition Powder Ensure for each meal.The duration of study is one day before colonoscopy.

Drug:
• 1.5L PEG
Low volume PEG

Other:
• Self-controlled diet
Self-controlled low residue diet.

Drug:
• 2L PEG
Normal volume of PEG

Locations

Country	Name	City	State
China	Ningbo first hospital	Ningbo	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Ningbo No. 1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	patients' satisfaction with the process of bowel preparation	At the end of the procedure, the patients were asked about the satisfaction with the process of bowel preparation. Satisfaction includes bad,not so bad and good.Bad means that the patient is not satisfied with the program, not so bad means that the patient is satisfied with the plan, and good means that the patient is very satisfied with the plan.	1day
Secondary	patients' willingness to have the colonoscopy done again at this facility in the future	It represent participants who wanted to choose the same protocol in the future as they received in this trial.Including yes and no two options, if yes, indicating that the patient is willing to undergo colonoscopy again, if no, indicating that the patient is reluctant to undergo colonoscopy again.	1day
Secondary	comparison with previous experience	If patients with colonoscopy times = 2, they need to compare with previous experience,Including better than last experience, similar to the last experience, and worse than the last experience.	1day
Secondary	adverse events	It represent the incidence of abdominal cramping, bloating, nausea/vomiting after intake of PEG and/or enteral nutrition was compared.	1day
Secondary	Convenience of Protocol between enteral nutrition with low volume 1.5L PEG and Self-controlled diet with normal amount of 2L PEG Protocol	It represented the percentage of patients who thinks the protocol is easy to use.	1day