Prepackaged Nutritional Formulations Versus Restricted Diet for Bowel Preparation

NCT04776733 | Unknown

• 1 other identifier: AHE 1.0
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bowel Preparation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

prepackaged group

EXPERIMENTAL

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

restricted diet group

ACTIVE COMPARATOR

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

Interventions

prepackaged semisolid nutritional formulations OTHER

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.

prepackaged group

restricted diet OTHER

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.

restricted diet group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

Study Sites (1)

Ningbo First Hospital

Ningbo, Zhejiang, 315010, China

RECRUITING

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 2, 2021
• Study Start: March 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-02

Locations

CN (1)