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…
ID
Bron
Verkorte titel
Aandoening
solitary encopresis in children
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Encopresis frequency;<br>
2. Rectal function: comparison between loperamide and placebo period.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksproduct en/of interventie
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.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL360 |
| NTR-old | NTR399 |
| Ander register | : N/A |
| ISRCTN | ISRCTN43733247 |