None listed
Conditions
Interventions
Drug : Participants get glycerin enema (1cc/kg) for disimpaction. group A with lactulose (1 to 3 mL/kg per day, b.i.d.), group B with lactulose + Saccharomyces boulardii (Bioflor 250 mg bid < 3 years,
Sponsors
Koera University Guro Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patients aged from 6 month to 6 years and fulfill the Rome IV criteria will be included in this study. Must include 1 month of at least 2 of the following in infants up to 4 years of age: 1. 2 or fewer defecations per week 2. History of excessive stool retention 3. History of painful or hard bowel movements 4. History of large-diameter stools 5. Presence of a large fecal mass in the rectum In toilet-trained children, the following additional criteria may be used: 6. At least 1 episode/week of incontinence after the acquisition of toileting skills 7. History of large-diameter stools that may obstruct the toilet Must include 2 or more of the following occurring at least once per week for a minimum of 1 month with insufficient criteria for a diagnosis of irritable bowel syndrome: 1. 2 or fewer defecations in the toilet per week in a child of a developmental age of at least 4 year 2. At least 1 episode of fecal incontinence per week 3. History of retentive posturing or excessive volitional stool retention 4. History of painful or hard bowel movements 5. Presence of a large fecal mass in the rectum 6. History of large diameter stools that can obstruct the toilet
Exclusion criteria
Exclusion criteria: Children with organic causes of constipation such as Hirschsprung’s disease, spinal bifida (occulta), hypothyroidism or other metabolic or renal abnormalities, mental retardation, and children using drugs (e.g. calcium channel blockers, antidysrhythmic agents, anticonvulsants, antidepressants, anticholinergic agents) influencing gastrointestinal function other than laxatives were excluded. The patients have been taking probiotics or lactulose steadily for more than 2 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment success rate (defecation > 3 episodes per weeks without soiling) | — |
Secondary
| Measure | Time frame |
|---|---|
| treatment change rate;pain during defecation;dose of lactulose;Bristol scale;adverse reaction;episode of defecation;soiling | — |
Countries
Korea, Republic of
Contacts
Public ContactKyung Jae Lee
Hallym University Medical Center
Outcome results
None listed