Clinical trial NCT05609591: Three Dietary Regimens in Pre-colonoscopic Bowel Preparation in Children
Official title: Three Dietary Regimens in Pre-colonoscopic Bowel Preparation in Children : A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Preparation
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 900
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To describe the feasibility and effectiveness of three dietary regimens in precolonoscopy bowel preparation in children

Detailed description: The accuracy of endoscopic diagnosis and treatment of safety depends largely on the intestinal cleaning quality. Qualified bowel preparation is a prerequisite for clear vision during colonoscopy. Presently, the common diet for children before colonoscopy in China is a liquid or low residual diet. The liquid and low residual diet often have poor taste and satiety, often resulting in poor compliance of children, especially young children, who are often unwilling to eat a liquid diet, resulting in insufficient caloric supply and unstable blood glucose during bowel preparation. Enteral formula as a kind of high-energy and low-fiber diet has been applied in clinical practice. Currently, there is no comparison between liquid diet, low-residue diet, and enteral formulas in children's bowel preparation in China. Dietary restriction is an indispensable part to ensure the success of the bowel preparation program. There is an urgent need to conduct research on the application of various dietary programs in children's bowel preparation before colonoscopy in China. In order to provide high-quality evidence for the bowel preparation diet program for children.

Eligibility criteria: Inclusion Criteria:

1. Age 2 years～18 years old
2. Children under anesthesia for elective colonoscopy with bowel preparation

Exclusion Criteria:

1. Children who are unable to perform bowel preparation with polyethylene glycol-4000
2. Children whose guardians refuse to participate in this study
3. Children who are unable to eat orally
4. Children with stomy

Primary outcomes:
measure: Boston Bowel Preparation Scale score
timeFrame: After the children finish their bowel preparation, an average of 5 minutes
Secondary outcomes:
measure: Revised-Bristol Stool Form Scale score
timeFrame: After the children finish their bowel preparation, an average of 5 minutes.
measure: The times of enema
timeFrame: After the children finish their enema, an average of 1 minute.
measure: Number of defecation during bowel preparation
timeFrame: After the children finish their bowel preparation, an average of 1 minute.
measure: Medication compliance
timeFrame: After the children finish their bowel preparation, an average of 3 minutes.
measure: Adverse reactions of bowel preparation
timeFrame: During children's bowel preparation, an average of 24 hours.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children'S Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Ying Gu, 3
role: STUDY_DIRECTOR
References:
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citation: Wu R, Ji WY, Yang C, Zhan Q. A Systematic Review and Meta-Analysis of Low-Residue Diet Versus Clear Liquid Diet: Which Is Better for Bowel Preparation Before Colonoscopy? Gastroenterol Nurs. 2021 Sep-Oct 01;44(5):341-352. doi: 10.1097/SGA.0000000000000554.