functional constipation
Conditions
Interventions
None listed
Sponsors
Maasstadziekenhuis
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: Functional Childhood Constipation in children under the age of 4 (Rome III criteria (31): Must include 1 month of at least 2 of the following in infants up to 4 years of age: 1. Two or fewer defecations per week, 2. at least 1 episode per week of incontinence after the acquisition of toileting skills, 3. History of excessive 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 may obstruct the toilet*. Functional Childhood constipation in a child with a developmental age of at least 4 years with insufficient criteria of IBS (Rome III criteria): Must include 2 or more of the following: 1. Two or fewer defecations per week, 2. at least one episode of fecal incontinence per week, 3. Stool retentive posturing, 4. Painful or hard bowel movements, 5. Large diameter stools that could obstruct the toilet, 6. Presence of a large fecal mass in the abdomen or rectum. Age 0 - 16 years. Written informed consent by both parents and/or by patient in the age of 12-18 years.
Exclusion criteria
Exclusion criteria: Children with organic cause of constipation: Hirschsprung*s disease, anorectal malformations, neuronal intestinal dysplasia, Spinal cord abnormalities, spinal cord trauma, neurofibromatosis, tethered cord, Hypothyroidism, diabetes mellitus, hypercalcemia, hypokalemia, vitamine D intoxication, Drug use: opoids, anticholinergic agents, antidepressants, Anorexia nervosa, sexual abuse, cystic fibrosis, dietary protein allergy. Age above 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A sustained response to treatment 6 months after start of treatment, defined as: the patient having a stool frequency of at least three times weekly, without fecal incontinence. Sustained response is defined as successfully treated as defined above in the absence of relapse of symptoms, and irrespective of laxative treatment. At 6 months patients are considered either responder or non-responder to therapy. | — |
Countries
Netherlands
Outcome results
None listed