Contact information
Type
Scientific
Primary contact
Dr M.A. Benninga
ORCID ID
Contact details
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)205663053
m.a.benninga@amc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR36
Study information
Scientific title
Acronym
Study hypothesis
1. Early intervention with oral and rectal laxatives will lead to a higher success percentage compared to standard treatment in constipated children
2. Long lasting fecal stasis leads to abnormal rectal functions (compliance and sensation)
3. Early frequent rectal laxatives prevent irreversible damage to rectal function
Ethics approval
Ethics approval received from the local ethics committee
Study design
Randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Constipation
Intervention
Group 1: weekly enemas and standard treatment
Group 2: standard treatment with oral laxative (movicolon)
Intervention type
Drug
Phase
Not Specified
Drug names
Movicolon
Primary outcome measures
1. Defecation frequency
2. Soiling/encopresis frequency
3. Stool consistency
4. Use of laxatives
Patients will visit our out-patient visits for follow-up at several fixed moments: intake and t = 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks, 39 weeks and 52 weeks. During this study, all patients will record in a specific diary on primary outcome measurements.
Secondary outcome measures
Rectal compliance and sensation at t = 0 and t = 52 weeks. A barostat is performed in all children pre-treatment and after one year of treatment and rectal functions are determined (rectal compliance and sensation). The results of t = 0 and t = 52 weeks are compared to assess possible differences in rectal function.
Overall trial start date
01/01/2003
Overall trial end date
01/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Rome II criteria for constipation
2. Aged 8 - 18 years
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Hirschsprung's disease
2. Gastrointestinal surgery
3. Anorectal anomaly
4. Metabolism disorders
5. Mental retardation
Recruitment start date
01/01/2003
Recruitment end date
01/12/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Emma Kinderziekenhuis
Postbus 22660
Amsterdam
1105 AZ
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Centre (AMC) (The Netherlands)
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