Prepackaged Nutritional Formulations Versus Restricted Diet for Bowel Preparation

Comparing the Efficacy and Tolerability of a Prepackaged Semisolid Nutritional Formulations With a Restricted Diet for Colonoscopy Preparation: A Randomized Clinical Trial.

In order to analyze the effectiveness and patient tolerance of the two bowel preparation regimens, the investigators will compare prepackaged semisolid nutritional formulations and restricted diet. The aim was to demonstrate that prepackaged semisolid nutritional formulations is not inferior in overall quality of intestinal preparation to restricted diet in subjects undergoing colonoscopy.

Study Overview

• Status: Unknown
• Conditions: Bowel Preparation
• Intervention / Treatment: Other: prepackaged semisolid nutritional formulations; Other: restricted diet

• Study Type: Interventional
• Enrollment (Anticipated): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315010
      • Recruiting
      • Ningbo First Hospital
      • Contact: Lie min Ruan, MD; Phone Number: +86-574-87085111; Email: master@nbdyyy.com

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:

• Patients age between 18-75 years old requiring colonoscopy and willing to participate in this study.

Exclusion Criteria:

1. Patients with constipation;
2. Patients with congestive heart failure;
3. Patients with a history of kidney disease;
4. Patients with a history of poor intestinal preparation;
5. Pregnant / lactating women;
6. Patients without informed consent;
7. Allergic or intolerant to any research drug;
8. Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis and toxic megacolon;
9. Patients with a history of inflammatory bowel disease;
10. History of colorectal resection；
11. Patients with diabetes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: prepackaged group; All colonoscopy were performed in the afternoon. The day before the colonoscopy: 3 bags of pre-packaged food were used for diet preparation. All the patients drink single dose of 60g Polyethylene Glycol (PEG-4000) with 1L water at a rate of 250 ml every 15 min in the evening. On the day of the colonoscopy: a bag of pre-packaged food were used for breakfast. All the patients drink single dose of 120g Polyethylene Glycol (PEG-4000) with 2L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min.	Other: prepackaged semisolid nutritional formulations; The day before the colonoscopy: 3 bags of pre-packaged food were used for diet preparation. On the day of the colonoscopy: a bag of pre-packaged food were used for breakfast.
ACTIVE_COMPARATOR: restricted diet group; All colonoscopy were performed in the afternoon. The day before the colonoscopy: restricted diet prepared by patients were used for diet preparation. All the patients drink single dose of 60g Polyethylene Glycol (PEG-4000) with 1L water at a rate of 250 ml every 15 min in the evening. On the day of the colonoscopy: restricted diet prepared by patients were used for breakfast. All the patients drink single dose of 120g Polyethylene Glycol (PEG-4000) with 2L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min.	Other: restricted diet; The day before the colonoscopy: restricted diet prepared by patients were used for diet preparation. On the day of the colonoscopy: restricted diet prepared by patients were used for breakfast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Bowel Preparation	The OBPS，a scoring system with scores between 0 and 14, where 0 is the best score，divides the colon into 3 segments (right, transverse and rectosigmoid colon); each is scored from 0-4 (0=excellent, If it is necessary to suction liquid stool to adequately see the colonic wall, a score of 2 (fair) is given; if it is necessary to wash and to suction, a score of 3 (poor) is given. The remaining scores fall into place around these anchors. ). A score 0-2 is added to indicate the total amount of luminal fluid.(0=The total amount of fluid in the colon is very small,1=a moderate volume of fluid overall in the colon,2=a large volume of fluid overall in the colon)	1 Day of colonoscopy

Collaborators and Investigators

• Sponsor: Ningbo No. 1 Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): October 1, 2021

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (ACTUAL): March 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: AHE 1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No