Three Dietary Regimens in Pre-colonoscopic Bowel Preparation in Children

NCT05609591 | Completed

• 1 other identifier: FNF20210820
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bowel Preparation

Outcome Measures

Primary Outcomes (1)

• Boston Bowel Preparation Scale score

  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.

  After the children finish their bowel preparation, an average of 5 minutes

Secondary Outcomes (5)

• Revised-Bristol Stool Form Scale score

  After the children finish their bowel preparation, an average of 5 minutes.

• The times of enema

  After the children finish their enema, an average of 1 minute.

• Number of defecation during bowel preparation

  After the children finish their bowel preparation, an average of 1 minute.

• Medication compliance

  After the children finish their bowel preparation, an average of 3 minutes.

• Adverse reactions of bowel preparation

  During children's bowel preparation, an average of 24 hours.

Study Arms (3)

Liquid diet group

EXPERIMENTAL

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.

Dietary Supplement: Liquid diet group

Enteral nutrition group

EXPERIMENTAL

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.

Dietary Supplement: Enteral nutrition group

Low residual diet group

EXPERIMENTAL

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.

Dietary Supplement: Low residual diet group

Interventions

Liquid diet group DIETARY_SUPPLEMENT

Fluid diet including juice, rice soup, filtered vegetable juice/broth, lotus root powder and milk and egg soup were given to children for bowel preparation.

Liquid diet group

Enteral nutrition group DIETARY_SUPPLEMENT

100% short peptide enteral nutrition are given to children for bowel preparation

Enteral nutrition group

Low residual diet group DIETARY_SUPPLEMENT

Low residua diet included gruel with grain only, peeled carrot, white gourd, powdered skin, tofu, vegetable, mud and fruit. were given to children for bowel preparation

Low residual diet group

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Children who are unable to perform bowel preparation with polyethylene glycol-4000
• Children whose guardians refuse to participate in this study
• Children who are unable to eat orally
• Children with stomy

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children'S Hospital of Fudan University

Shanghai, Shanghai Municipality, 201100, China

Location

Related Publications (5)

• Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.

  PMID: 15758907 RESULT

• Belsey J, Epstein O, Heresbach D. Systematic review: oral bowel preparation for colonoscopy. Aliment Pharmacol Ther. 2007 Feb 15;25(4):373-84. doi: 10.1111/j.1365-2036.2006.03212.x.

  PMID: 17269992 RESULT

• Barkun A, Chiba N, Enns R, Marcon M, Natsheh S, Pham C, Sadowski D, Vanner S. Commonly used preparations for colonoscopy: efficacy, tolerability, and safety--a Canadian Association of Gastroenterology position paper. Can J Gastroenterol. 2006 Nov;20(11):699-710. doi: 10.1155/2006/915368.

  PMID: 17111052 RESULT

• Mytyk A, Lazowska-Przeorek I, Karolewska-Bochenek K, Kakol D, Banasiuk M, Walkowiak J, Albrecht P, Banaszkiewicz A. Clear Liquid Versus Low-fibre Diet in Bowel Cleansing for Colonoscopy in Children: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2018 May;66(5):720-724. doi: 10.1097/MPG.0000000000001832.

  PMID: 29112090 RESULT

• 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.

  PMID: 34238885 RESULT

Study Officials

• Ying Gu, 3

  Children's Hospital of Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 8, 2022
• Study Start: November 9, 2022
• Primary Completion: January 30, 2024
• Study Completion: July 30, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)