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

ISRCTN ISRCTN43733247
DOI https://doi.org/10.1186/ISRCTN43733247
Secondary identifying numbers NTR399
Submission date
27/01/2006
Registration date
27/01/2006
Last edited
01/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M.A. Benninga
Scientific

Academic Medical Center
Pediatric Department
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone +31 (0)20 5663053
Email m.a.benninga@amc.nl

Study information

Study designRandomised double blind placebo controlled crossover group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectives1. We hypothesise that children with solitary encopresis have a disturbed compensation reflex, eventually combined with aberrant huge rectal contractions
2. We hypothesise that in children with solitary encopresis loperamide rectally given, will reduce rectal activity and consequently exert its clinical effect
Ethics approval(s)Received from local medical ethics committee
Health condition(s) or problem(s) studiedEncopresis, solitary
InterventionPeriod 1: 1 month suppositories either placebo or loperamide twice daily 5 mg + diary chart.
Combine rectal manometry and barostat at end of period.
Period 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.
Intervention typeOther
Primary outcome measure1. Encopresis frequency
2. Rectal function: comparison between loperamide and placebo period
Secondary outcome measures3. Side effects of loperamide suppositories
Overall study start date01/01/2003
Completion date01/08/2005

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participants10
Key inclusion criteriaTo enter the study the patients have to fulfil the following criteria:
1. Encopresis frequency of ≥ 2 times/week
2. Colonic transit time ≥ 62 hours
3. At least 3 years treatment without success (biofeedback training, laxatives, toilet training)
4. Age of the child ≥ 8 years
Key exclusion criteria1. Colonic transit time >62 hours
2. Other signs of constipation:
2.1. Defecation frequency <2 times per week
2.2. Periodic passage of very large amounts of stool
2.3. A 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
Date of first enrolment01/01/2003
Date of final enrolment01/08/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Center
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Centre (Netherlands)
Hospital/treatment centre

Pediatric Department
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Hospital/treatment centre

Academic Medical Centre (AMC) (Netherlands) - Department of Pediatrics

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan