Optimal strategy for stopping medication for chronic functional constipation in children: Randomized controlled multicenter study
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0006286
- Lead Sponsor
- Hallym University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
1) Pediatric patients diagnosed with functional constipation based on ROME IV diagnosis criteria at ages 6 months to under 7 years of age
2) If the Lactulose administration continues for more than two months and the treatment has been successful for more than three months,
3) Criteria for success in treatment
- Children trained to defecate: defecate more than three times a week + no incontinence.
- Infants who have not been trained to defecate: defecate more than three times a week + no defecation pain
In case of constipation due to organic causes.
- Patients with congenital megacolon,, spina bifida, hypothyroidism, metabolic abnormalities, mental retardation, taking medication affect the digestive organs, and other digestive disorders are present;
- Patients taking different laxative than probiotics
- Patients who require psychiatric treatment or nutrition counseling in addition to medication under the judgment of the medical staff due to their discomfort with severe eating or severe bowel movements.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sustained success rate after end of treatment
- Secondary Outcome Measures
Name Time Method Freqeunce of defecation per week, incontinence, stool consistency, defecation pain, hematochezia, compliance, Treatment Satisfaction