Prepackaged Nutritional Formulations Versus Restricted Diet for Bowel Preparation

Bowel Preparation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04776733
• Other study ID #: AHE 1.0
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: February 2021
• Source: Ningbo No. 1 Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: October 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bowel Preparation

Intervention

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.
• 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.

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	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