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

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.

Study Overview

• Status: Unknown
• Conditions: Bowel Preparation
• Intervention / Treatment: Dietary supplement: Enteral Nutrition Powder Ensure; Drug: 1.5L PEG; Other: Self-controlled diet; Drug: 2L PEG

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315010
      • Ningbo First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enteral Nutritional+PEG; Enteral Nutritional Powder with low volume 1.5L PEG	Dietary supplement: Enteral Nutrition Powder Ensure; Enteral Nutrition Powder Ensure for each meal.The duration of study is one day before colonoscopy.; Other Names: Ensure; Drug: 1.5L PEG; Low volume PEG; Other Names: Hengkangzhengqing
Placebo Comparator: Self-controlled diet+PEG; Self-controlled diet with normal amount of 2L PEG	Other: Self-controlled diet; Self-controlled low residue diet.; Drug: 2L PEG; Normal volume of PEG; Other Names: Hengkangzhengqing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
adverse events	It represent the incidence of abdominal cramping, bloating, nausea/vomiting after intake of PEG and/or enteral nutrition was compared.	1day
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

Collaborators and Investigators

• Sponsor: Ningbo No. 1 Hospital
• Investigators: Principal Investigator: Hongpeng Lu, master, Department of Gastroenterology, Ningbo No. 1 Hospital, Ningbo, China

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: July 5, 2019
• First Submitted That Met QC Criteria: July 14, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 14, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2017-R035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No