ConstipationNCT01582659
Outpatient Treatment of Constipation in Children
A study testing Telephone counseling and Web access in people with Constipation, run by Line Modin at 2 sites in Denmark.
Trial summary
Constipation is a condition often seen in children. Constipation is often associated with impaired quality of life of the child and of great concern among parents. Despite the fact that both diagnosis and treatment is a simple task, it is often seen that the treatment fails, and many children are referred to a… Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Constipation
- What is being tested?
- Telephone counseling and Web access
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 2 sitesDenmark
- Study dates
- Jun 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 2 and 16 years and referral to our out patient clinic with either constipation or fecal incontinence.
- Patients must fulfill the Rome III criteria of constipation, which mean they must have at least 2 of the following characteristics: fewer than 3 bowel movements weekly, more than 1 episode of fecal incontinence weekly, large stools in the rectum by digital rectal examination or palpable on abdominal examination, occasional passing of large stools, display of retentive posturing and withholding behavior, and painful defecation.
Who cannot join
- Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases.
- Children receiving drugs known to affect bowel function during a 2 month period before initiation.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Line Modin
Kolding, 6000
Pediatric department, Kolding Hospital
Kolding, 6000
About this study
Official title: Outpatient Treatment of Constipation in Children - a Randomized Interventions Study
Constipation is a condition often seen in children. Constipation is often associated with impaired quality of life of the child and of great concern among parents. Despite the fact that both diagnosis and treatment is a simple task, it is often seen that the treatment fails, and many children are referred to a pediatric ward for specialized treatment.
There is currently little research on the subject and treatment is therefore based on expert knowledge rather than scientific research.
Read more
The study objective is to identify the most effective and least stressful treatment of children with constipation for both families and the health care system.
The following will be tested:
Does treatment of constipation in children require specialized knowledge and extensive resources or can the treatment be simplified?
The results from this study are expected to form the basis for a evidence based treatment of children with constipation.
- Conditions
- Constipation
- Being tested
- Telephone counseling, Web access
- Keywords
- constipation, children, outpatient
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone counselingOther
Also called Telephone
2 planned telephone counseling sessions are conducted.
Web accessOther
Also called Web
Access to a web site with information about childhood constipation similar to the information given at the first visit to the clinic.
| Study group | Role | What they receive |
|---|---|---|
| No ekstra counseling | No intervention | Standardized information about childhood constipation is given and the child receives PEG 3350. No additional follow up appointments are made. |
| 2 counseling sessions | Active comparator | Standardized information about childhood constipation is given and the child receives PEG 3350. 2 additional follow up appointments by telephone are made. Receives: Other: Telephone counseling |
| Web access | Active comparator | Standardized information about childhood constipation is given and the child receives PEG 3350. No additional follow up appointments are made but the family are given access to a website with information about childhood constipation. Receives: Other: Web access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment recovery
Recovery is defined as the child having no symptoms of constipation according to the Rome III chriteria.
Measured: 1 year
Secondary outcomes (2)
Usage of laxative.
Amount of laxative used during the study periode.
Measured: 1 year
Telephone contacts
Number of telephone contacts during the study periode, both planned and unplanned contacts will be noted.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Line Modin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Sponsor-investigator, Line Modin, Vejle Hospital
- Investigators
- Marianne Jakobsen, MD, PhD, Study director, KoldingPoul Erik Kofoed, MD. PHD, Study chair, KoldingLine Modin, MD, Principal investigator, Kolding
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582659
- Sponsor's protocol ID
- OutCon
- Status last verified
- Dec 2014
- First submitted
- 27 Mar 2012
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Modin L, Walsted AM, Rittig CS, Hansen AV, Jakobsen MS. Follow-up in Childhood Functional Constipation: A Randomized, Controlled Clinical Trial. J Pediatr Gastroenterol Nutr. 2016 Apr;62(4):594-9. doi: 10.1097/MPG.0000000000000974.
PubMed 26348685
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Treatment of Constipation in Children - a Randomized Interventions Study
- ClinicalTrials.gov ID
- NCT01582659
- Acronym / sponsor ID
- OutCon
- Conditions
- Constipation
- Keywords
- constipation, children, outpatient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Line ModinUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- Jun 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Constipation is a condition often seen in children. Constipation is often associated with impaired quality of life of the child and of great concern among parents. Despite the fact that both diagnosis and treatment is a simple task, it is often seen that the treatment fails, and many children are referred to a pediatric ward for specialized treatment.
There is currently little research on the subject and treatment is therefore based on expert knowledge rather than scientific research.
The study objective is to identify the most effective and least stressful treatment of children with constipation for both families and the health care system.
The following will be tested:
Does treatment of constipation in children require specialized knowledge and extensive resources or can the treatment be simplified?
The results from this study are expected to form the basis for a evidence based treatment of children with constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No ekstra counseling | No intervention | –Standardized information about childhood constipation is given and the child receives PEG 3350. No additional follow up appointments are made. |
| 2 counseling sessions | Active comparator | Other: Telephone counselingStandardized information about childhood constipation is given and the child receives PEG 3350. 2 additional follow up appointments by telephone are made. |
| Web access | Active comparator | Other: Web accessStandardized information about childhood constipation is given and the child receives PEG 3350. No additional follow up appointments are made but the family are given access to a website with information about childhood constipation. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children between 2 and 16 years and referral to our out patient clinic with either constipation or fecal incontinence.
- Patients must fulfill the Rome III criteria of constipation, which mean they must have at least 2 of the following characteristics: fewer than 3 bowel movements weekly, more than 1 episode of fecal incontinence weekly, large stools in the rectum by digital rectal examination or palpable on abdominal examination, occasional passing of large stools, display of retentive posturing and withholding behavior, and painful defecation.
Key exclusion criteria (2 listed)
- Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases.
- Children receiving drugs known to affect bowel function during a 2 month period before initiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone counselingAlso: Telephone2 planned telephone counseling sessions are conducted. | Other | 2 counseling sessions |
| Web accessAlso: WebAccess to a web site with information about childhood constipation similar to the information given at the first visit to the clinic. | Other | Web access |
Primary outcome
Treatment recovery
Time frame: 1 year
Recovery is defined as the child having no symptoms of constipation according to the Rome III chriteria.
2 secondary outcomes
Usage of laxative.
Time frame: 1 year
Telephone contacts
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
- Derived from this study: PubMed 26348685Modin L, Walsted AM, Rittig CS, Hansen AV, Jakobsen MS. Follow-up in Childhood Functional Constipation: A Randomized, Controlled Clinical Trial. J Pediatr Gastroenterol Nutr. 2016 Apr;62(4):594-9. doi: 10.1097/MPG.0000000000000974.
Related trials for Constipation
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Jakobsen, MD, PhD study director
Kolding
Poul Erik Kofoed, MD. PHD study chair
Kolding
Line Modin, MD principal investigator
Kolding
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone counseling and Web access in people with Constipation, run by Line Modin at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment recovery (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01582659, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014.