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ID
Source
Brief title
Health condition
solitary encopresis in children
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Encopresis frequency;
2. Rectal function: comparison between loperamide and placebo period.
Secondary outcome
Side effects loperamide supps.
Background 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.
Study objective
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.
Intervention
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.
P.O. Box 22660
Marc A. Benninga
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663053 / +31 (0)20 5666297
m.a.benninga@amc.nl
P.O. Box 22660
Marc A. Benninga
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663053 / +31 (0)20 5666297
m.a.benninga@amc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL360 |
| NTR-old | NTR399 |
| Other | : N/A |
| ISRCTN | ISRCTN43733247 |