Three Dietary Regimens in Pre-colonoscopic Bowel Preparation in Children

Not Applicable

Completed

• Conditions: Bowel Preparation
• Interventions: Dietary Supplement: Enteral nutrition group; Dietary Supplement: Low residual diet group; Dietary Supplement: Liquid diet group

• Registration Number: NCT05609591
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-08
• Study Start: 2022-11-09
• Primary Completion: 2024-01-30
• Study Completion: 2024-07-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-20
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enteral nutrition group	Enteral nutrition group	Oral administration of 100% short peptide enteral nutrition preparation from 8:00 on the day before colonoscopy. The fasting starts at 9:00 AM on the day of colonoscopy.
Low residual diet group	Low residual diet group	From 8:00 on the day before colonoscopy, the patients were given oral administration of less residue food included gruel with grain only, peeled carrot, white gourd, powdered skin, tofu, vegetable, mud and fruit. The fasting starts at 9:00 AM on the day of colonoscopy.
Liquid diet group	Liquid diet group	From 8:00 on the day before colonoscopy, oral fluids including juice, rice soup, filtered vegetable juice/broth, lotus root powder and milk and egg soup were taken to ensure energy intake and blood glucose stability. The fasting starts at 9:00 AM on the day of colonoscopy.

Primary Outcome Measures

Name	Time	Method
Boston Bowel Preparation Scale score	After the children finish their bowel preparation, an average of 5 minutes	The nurse will use the Boston Bowel Preparation Scale colonoscopic to evaluate the intestinal fecal trait under colonoscope and record in the case report form. The right side (cecum and ascending colon), transverse colon (hepatic flexion and splenic flexion) and left side (descending colon, sigmoid colon and rectum) were scored respectively. 0 score: a large amount of solid stool remains in the colon; 1 score: liquid and semi-solid feces exist in some intestinal segments; 2 points: a small amount of feces remains, but does not affect the colonoscopic field of view; 3 points: no solid liquid fecal residue in the colon.; The total score of the scale is 9 points, 8-9 points is excellent; 6-7 points is good; 4-5 points is average; 0-3 points is Poor.

Secondary Outcome Measures

Name	Time	Method
Number of defecation during bowel preparation	After the children finish their bowel preparation, an average of 1 minute.	The number of defecation during bowel preparation will be recorded in the case report form by the nurse.
Adverse reactions of bowel preparation	During children's bowel preparation, an average of 24 hours.	Acceptable safety indicators: occasional and mild nausea, vomiting, abdominal pain, abdominal distension; a few sporadic rashes; perianal discomfort.; Indicators need to be closely monitored: frequent and severe vomiting, abdominal pain, abdominal distension, blood in the stool; Widespread or diffuse rash.; Unacceptable indicators: fecal incontinence, dehydration, and electrolyte disturbance; intestinal perforation; shock.; All the adverse reactions will be observed and recorded in the case report form by the nurse.
Revised-Bristol Stool Form Scale score	After the children finish their bowel preparation, an average of 5 minutes.	The fecal traits are recorded in the case report form by the nurse with a Revised-Bristol Stool Form Scale according to the stool characteristics of children. The score was 8 points in order: 8 points: clear water stool, no residue; 7 points: turbid water sample, with or without a small amount of fecal residue; 6 points: velvet, unclear edge, mushy stool; 5 points: soft mass, clear edge; 4 points: like sausage or snake, smooth and soft; 3 points: sausage-shaped, but with cracks on the surface; 2 points: sausage-shaped, but in chunks; 1 point: scattered hard pieces, like nuts. A score of 8 indicates that the naked eye assessment of bowel preparation is qualified, and colonoscopy can be performed directly. A score of 6-7 indicates that bowel preparation is not sufficient, and a colonoscopy should be performed at the selected day. ≤5 points is recommended to cancel the colonoscopy on the same day and extend the bowel preparation time.
Medication compliance	After the children finish their bowel preparation, an average of 3 minutes.	Children who complete less than 30% polyethylene glycol 4000 (PEG-4000) are defined as having poor compliance, completing 30%\~60% PEG-4000 is fair compliance, completing 60%\~80% PEG-4000 is good compliance, and great than 80% PEG-4000 is excellent compliance. The nurse will evaluate children's compliance according to their completion of PEG-4000 and record it in the case report form.
The times of enema	After the children finish their enema, an average of 1 minute.	Children with substandard bowel preparation before colonoscopy were going to undergo enemas to ensure the visual clarity of colonoscopy. The times of enema will be recorded by the nurse who perform the enema in the case report form.

Trial Locations

Locations (1)

Children'S Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China