Mizone vs Water for Bowel Preparation.

Bowel Preparation Clinical Trial

Official title:

The Efficacy and Tolerability of Mizone Versus Water in Bowel Preparations: a Randomised Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04247386
• Other study ID #: PEG-1.0
• Status: Completed
• Phase: N/A
• Start date: December 25, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: September 2020
• 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, we will compare Polyethylene Glycol Electrolytes Powder (PEG-4000) and Mizone with PEG-ELS. The aim was to demonstrate that polyethylene glycol electrolyte powder (PEG-4000) and Mizone is not inferior in overall quality of intestinal preparation to PEG-ELS in subjects undergoing colonoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: August 31, 2020
• Est. primary completion date: August 1, 2020
• 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. Significant electrolyte anomalies, including phosphorus, sodium, potassium, calcium, chloride and magnesium;

11. History of colorectal resection;

12. Patients with diabetes.

Related Conditions & MeSH terms

• Bowel Preparation

Intervention

Drug:
• PEG-Mizone
The evening before the colonoscopy:60gPEG-4000 was mixed with 0.6LMizone and 0.4L water. On the day of the colonoscopy:4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 1.2LMizone and 0.8L water.
• PEG-ELS
The evening before the colonoscopy:60gPEG-4000 was mixed with 1L water. On the day of the colonoscopy:4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 2L water.

Locations

Country	Name	City	State
China	Ningbo No. 1 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
Secondary	Adverse event rate	Including Electrolyte disorders requiring clinical treatment, etc.	3 days
Secondary	patient tolerability of bowel preparation	On the day of the patient's colonoscopy, each patient will complete another form regarding their bowel preparation experience with a modified 5-point Likert scale for ease of use (score 5-1: very easy, easy, tolerable, difficult or very difficult).	1 Day of colonoscopy