Condition category
Digestive System
Date applied
04/08/2005
Date assigned
04/08/2005
Last edited
11/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl/

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

Publication citations

Additional files

Editorial Notes