Treatment of childhood conspitaion.

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

• Referred children to the pediatric out patient clinic with either constipation or fecal incontinence, age 2 to 16 years.

• Children must meet the ROME III criteria. This means that children below 4 years must meet at least 2 of the following criteria during a month, children above 4 years must meet at least 2 of the criteria at least once a week for 2 months:
• Two or fewer bowel movements weekly.
• More than one episode of fecal incontinence weekly.
• Painful defecation.
• Occasional passage of large stools.
• Display of retentive posturing and withholding behavior.
• Large stools in the rectum identified by digital examination or palpable on abdominal examination.
Rome III criteria is developed by scientists and widely internationally accepted among research in childhood constipation.

Are the trial subjects under 18? yes
Number of subjects for this age range: 125
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Children not eligible for participation is children who receive treatment with medications known to affect bowel function, apart from laxatives, within a 2-month period and children e.g. with known organic causes of constipation including Hirschsprung disease, previous surgery on the colon or inflammatory bowel disease.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of the study is to investigate the effect of maintenance treatment with macrogol 3350 + electrolytes (PEG 3350 + E) in the treatment of childhood constipation in a randomized, placebo-controlled design.;Secondary Objective: - Consumption of study medication.<br>- Number of re-constipated children who need to switch to active treatment.<br>- Changes in stool frequency, fecal incontinence episodes and abdominal pain.<br>;Primary end point(s): Treatment effect.<br>Treatment effect is defined as absence or continued presence of symptoms of constipation based on the Rome III criteria with or without medication. Primaty outcom is calculated in an intention to treat analysis-;Timepoint(s) of evaluation of this end point: 6 months after inclusion

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Consumption of study medication.<br>- Number of re-constipated children who need to switch to active treatment.<br>- Changes in stool frequency, fecal incontinence episodes and abdominal pain.<br><br>;Timepoint(s) of evaluation of this end point: - Consumption of study medication will be evaluated at each visit and at the end of the trial.<br>- Number of re-constipated children who need to switch to active treatment will be evaluated at each visit and at the end of the trial.<br>- Changes in stool frequency, fecal incontinence episodes and abdominal pain will be evaluated at each visit and at the end of the trial.<br>