Contact information
Type
Scientific
Primary contact
Dr M.A. Benninga
ORCID ID
Contact details
Academic Medical Center
Pediatric Department
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5663053
m.a.benninga@amc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR399
Study information
Scientific title
Acronym
Study hypothesis
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
Received from local medical ethics committee
Study design
Randomised double blind placebo controlled crossover group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
1. Encopresis frequency
2. Rectal function: comparison between loperamide and placebo period
Secondary outcome measures
3. Side effects of loperamide suppositories
Overall trial start date
01/01/2003
Overall trial end date
01/08/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
10
Participant 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
Recruitment start date
01/01/2003
Recruitment end date
01/08/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Centre (AMC) (Netherlands) - Department of Pediatrics
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary