The effect of loperamide in childhood idiopathic faecal incontinence: the compensation reflex of the anorectal complex and clinical outcome
ISRCTN | ISRCTN43733247 |
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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
Scientific
Academic Medical Center
Pediatric Department
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Phone | +31 (0)20 5663053 |
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m.a.benninga@amc.nl |
Study information
Study design | Randomised double blind placebo controlled crossover group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study objectives | 1. 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) studied | Encopresis, solitary |
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. 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 type | Other |
Primary outcome measure | 1. Encopresis frequency 2. Rectal function: comparison between loperamide and placebo period |
Secondary outcome measures | 3. Side effects of loperamide suppositories |
Overall study start date | 01/01/2003 |
Completion date | 01/08/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Sex | Both |
Target number of participants | 10 |
Key inclusion criteria | To 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 criteria | 1. 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. Hirschsprungs disease 11. Any other (gastrointestinal) disease with a possible influence on gastrointestinal motility |
Date of first enrolment | 01/01/2003 |
Date of final enrolment | 01/08/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Pediatric Department
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |