A prospective, controlled, randomized, assessor-blind, comparative study of a new oral bowel cleanser (Sodium Picosulfate/Magnesium Citrate) versus existing oral bowel cleanser (Magnesium Citrate) in pediatric colonoscopy preparation.

Not Applicable

Recruiting

• Conditions: Inflammatory bowel disease, Functional gastrointestinal disorders, Eosinophilic gastroenteritis, Colorectal polyps, others

• Registration Number: JPRN-UMIN000046015
• Lead Sponsor: Saitama children's Medical Center Division of Gastroenterology and Hepatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-15
• Study Completion: 2022-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

Not provided

Exclusion Criteria

Patients with emergency endoscopy, intestinal occlusion, toxic megacolon, electrolyte abnormalities, previous ductal resection, metabolic disorders, renal disorders, cardiac disorders, post-transplant acute GVHD suspicion, weight under 20 kg, Patients with a history of PICO administration and others(treating physicians judged as inappropriate)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bowel cleansing effect by Boston bowel preparation scale

Secondary Outcome Measures

Name	Time	Method
Side effects (nausea, vomiting and abdominal pain during administration, electrolytes and renal function on the day of CS) Patient acceptability (taste, ease of taking, dosage, desire for re-administration, overall evaluation) Parental acceptability (overall evaluation)