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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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04776733
Enrollment
196
Registered
2021-03-02
Start date
2021-03-01
Completion date
2021-10-01
Last updated
2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Preparation

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.

Interventions

OTHERprepackaged 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.

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.

Sponsors

Ningbo No. 1 Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Quality of Bowel Preparation1 Day of colonoscopyThe 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)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026