|- candidate number||1644|
|- NTR Number||NTR399|
|- Date ISRCTN created||27-jan-2006|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||13-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||The effect of loperamide in childhood idiopathic faecal incontinence: the compensation reflex of the anorectal complex and clinical outcome.|
|- Scientific Title||The effect of loperamide in childhood idiopathic faecal incontinence: the compensation reflex of the anorectal complex and clinical outcome.|
|- hypothesis||1. We hypothesize that children with solitary encopresis have a disturbed compensation reflex, eventually combined with aberrant huge rectal contractions;|
2. We hypothesize that in children with solitary encopresis loperamide rectally given, will reduce rectal activity and consequently exert its clinical effect.
|- Healt Condition(s) or Problem(s) studied||Solitary encopresis |
|- Inclusion criteria||To enter the study the patients have to fulfil the following criteria:|
1. Encopresis frequency of = of > 2 times / week;
2. Colonic transit time < or = 62 hours;
3. At least 3 years treatment without success (biofeedback training, laxatives, toilet training);
4. Age of the child = or > 8 yrs.
|- Exclusion criteria||1. Colonic transit time > 62 uur;
2. Other signs of constipation:
a. Defecation frequency < 2 times per week; or
b. Periodic passage of very large amounts of stool; or
c. Palpable abdominal or rectal mass;
3. Anorectal malformations;
4. Impaired neurological functioning such as spina bifida;
5. Evident psychiatric diagnosis such as depressive disorder;
6. Metabolic diseases;
7. Using drugs influencing gastrointestinal motility;
8. Mental retardation;
9. Any abdominal or anorectal surgical intervention;
10. Hirschsprung’s disease;
11. Any other (gastrointestinal) disease with a possible influence on gastrointestinal motility.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-jan-2003|
|- planned closingdate||1-aug-2005|
|- Target number of participants||10|
|- Interventions||period 1: 1 month suppositories either placebo or loperamide twice daily 5 mg + diary chart|
- combine rectal manometry and barostat at end of period
periode 2: 1 month wash-out + diary chart
period 3: 1 month suppositories either placebo or loperamide twice daily 5 mg + diary chart
- combine rectal manometry and barostat at end of period.
|- Primary outcome||1. Encopresis frequency;|
2. Rectal function: comparison between loperamide and placebo period.
|- Secondary outcome||Side effects loperamide supps.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. Marc A. Benninga|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. Marc A. Benninga|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Pediatric|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Department of Pediatric |
|- Brief summary||Trail in order to reveal the effect of loperamide on solitairy encopresis in children. |
The effect is clinically assessed through diary charts during three periods, 1 with loperamide, 1 wash-out, and 1 placebo period.
Furthermore, the effect of loperamide on the anorectal function is assessed through a combined anorectal manomatry and barostat measurement.
|- Main changes (audit trail)|
|- RECORD||13-sep-2005 - 7-mrt-2006|