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
Protocol serial number	NTR399
Sponsor	Academic Medical Centre (Netherlands)
Funder	Academic Medical Centre (AMC) (Netherlands) - Department of Pediatrics

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

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

Primary study design	Interventional
Study design	Randomised double blind placebo controlled crossover group trial
Secondary study design	Randomised controlled trial
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(s)	1. Encopresis frequency 2. Rectal function: comparison between loperamide and placebo period
Key secondary outcome measure(s)	3. Side effects of loperamide suppositories
Completion date	01/08/2005

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	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

Academic Medical Center

Amsterdam
1100 DD
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan