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Optimal strategy for stopping medication for chronic functional constipation in children: Randomized controlled multicenter study

Optimal strategy for stopping medication for chronic functional constipation in children: Randomized controlled multicenter study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0006286
Enrollment
120
Registered
2021-06-23
Start date
2020-09-01
Completion date
Unknown
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : We divided the patients into 4 groups by treatment successful duration and tapering regimen. (A) Successful treatment duration more than 3 months + weekly 1/8 dose reduction over 12 weeks (

Sponsors

Hallym University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Sustained success rate after end of treatment

Secondary

MeasureTime frame
Freqeunce of defecation per week, incontinence, stool consistency, defecation pain, hematochezia, compliance, Treatment Satisfaction

Countries

Korea, Republic of

Contacts

Public ContactKyung Lee

Hallym University Medical Center

cuty2kj@hanmail.net+82-31-380-3730

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026