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van CCT (UK)


The effect of loperamide in childhood idiopathic faecal incontinence: the compensation reflex of the anorectal complex and clinical outcome.


- candidate number1644
- NTR NumberNTR399
- ISRCTNISRCTN43733247
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR13-sep-2005
- Secondary IDsN/A 
- Public TitleThe effect of loperamide in childhood idiopathic faecal incontinence: the compensation reflex of the anorectal complex and clinical outcome.
- Scientific TitleThe effect of loperamide in childhood idiopathic faecal incontinence: the compensation reflex of the anorectal complex and clinical outcome.
- ACRONYMN/A
- hypothesis1. 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) studiedSolitary encopresis
- Inclusion criteriaTo 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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type-
- Studytypeintervention
- planned startdate 1-jan-2003
- planned closingdate1-aug-2005
- Target number of participants10
- Interventionsperiod 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 outcome1. Encopresis frequency;
2. Rectal function: comparison between loperamide and placebo period.
- Secondary outcomeSide effects loperamide supps.
- Timepoints
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. PhD. Marc A. Benninga
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Marc A. Benninga
- Sponsor/Initiator Academic Medical Center (AMC), Department of Pediatric
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Pediatric
- PublicationsN/A
- Brief summaryTrail 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)
- RECORD13-sep-2005 - 7-mrt-2006


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