Prepackaged Nutritional Formulations Versus Restricted Diet for Bowel Preparation

Sponsor

Ningbo No. 1 Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04776733

Collaborator

(none)

196

Enrollment

Location

Arms

Anticipated Duration (Months)

27.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bowel Preparation	Other: prepackaged semisolid nutritional formulations Other: restricted diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

196 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Quality of Bowel Preparation [1 Day of colonoscopy]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ningbo First Hospital	Ningbo	Zhejiang	China	315010

Sponsors and Collaborators

Ningbo No. 1 Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ningbo No. 1 Hospital

ClinicalTrials.gov Identifier:

NCT04776733

Other Study ID Numbers:

AHE 1.0

First Posted:

Mar 2, 2021

Last Update Posted:

Apr 8, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 8, 2021