ConstipationNCT00677508
Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling
An observational study of Constipation and Fecal Incontinence, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
We propose to develop parent and child disease-specific instruments to assess health related quality of life (HRQoL) in children with constipation and fecal incontinence. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Constipation, Fecal Incontinence
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Aug 2011
- Phase
- Observational
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children will be recruited from the Constipation Clinic at Children's Hospital of Wisconsin, as well as four coolaborating sites.
Who may be able to join
- Age 2-18 years
- Child and parents fluent in English
- Child must meet one of the following criteria;
- Constipation and fecal incontinence: must include 2 or more of the following in a child with insufficient criteria for a diagnosis of IBS (criteria fulfilled at least once per week for at least 2 months before diagnosis in a child over 4 years of age and for at least one month in a child less than 4 years of age):
- Two or fewer defecations in the toilet per week
- At least 1 episode of fecal incontinence per week
Show all 20Show fewer
- History of retentive posturing or excessive volitional stool retention
- History of painful or hard bowel movements
- Presence of a large fecal mass in the rectum
- History of large diameter stools that may obstruct the toilet
- Constipation predominant IBS: must include the following, once a week for at least 2 months:
- Abdominal pain/discomfort, associated with 2 of the following:
- improved with defecation
- onset associated with 2 or less stools per week
- onset associated with hard or lump stool
- no evidence of inflammatory, anatomic, metabolic or neoplastic processes.
- Non retentive fecal incontinence: must include all of the following in a child with a developmental age of at least 4 years (criteria fulfilled at least once per week for at least 2 months before diagnosis) [4]:
- Defecation into places inappropriate to the social context at least once per month.
- No evidence of an inflammatory, anatomic, metabolic, or neoplastic process that explains the subject's symptoms
- No evidence of fecal retention.
Who cannot join
- Children with developmental delays and children over 12 years of age who are unable to understand the questionnaires.
- Associated chronic disease which may have an impact on quality of life such as cerebral palsy, spine deformity or malformations, learning difficulties, severe mental illness, celiac disease, etc.
- Child and parents not fluent in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
We propose to develop parent and child disease-specific instruments to assess health related quality of life (HRQoL) in children with constipation and fecal incontinence.
Read the detailed description
Chronic constipation is a common problem in childhood, accounting for almost 3% of consultations in pediatric practice. In many children constipation is accompanied by overflow soiling (fecal incontinence). This condition often gives rise to behavioral, social, and emotional problems.
We plan to develop a disease-specific instrument to assess HRQoL in children with constipation and fecal incontinence. We hypothesize that HRQoL is worse in children with fecal incontinence compared to children with constipation but no fecal incontinence. The instrument will involve both parent and child self-reporting measures and will enable researchers to evaluate how disease and treatment strategies impact both child and parent perceptions of quality of life. In the long run this will enable physicians to develop a child friendly approach to management of chronic constipation and fecal incontinence.
- Conditions
- Constipation, Fecal Incontinence
- Keywords
- Constipation, Fecal incontinence, Quality of life, Health related quality of life
- Medical subject headings
- Constipation, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| C FR | Children with constipation and fecal incontinence. | |
| C | Children with constipation but without fecal incontinence. | |
| P-C FR | Parents of children with constipation and/or fecal incontinence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop and validate child and parent questionnaires to assess HRQoL of children with chronic constipation and fecal incontinence.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startSep 2005
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc., University of South Alabama, Boston Children's Hospital, Ohio State University, University of Texas Southwestern Medical Center
- Responsible party
- Principal investigator, Manu Sood, Medical College of Wisconsin
- Investigators
- Manu Sood, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677508
- Sponsor's protocol ID
- CHW 05/154
- Status last verified
- Apr 2020
- First submitted
- 9 May 2008
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Treurniet HF, Essink-Bot ML, Mackenbach JP, van der Maas PJ. Health-related quality of life: an indicator of quality of care? Qual Life Res. 1997 May;6(4):363-9. doi: 10.1023/a:1018435427116.
PubMed 9248318Brooks RC, Copen RM, Cox DJ, Morris J, Borowitz S, Sutphen J. Review of the treatment literature for encopresis, functional constipation, and stool-toileting refusal. Ann Behav Med. 2000 Summer;22(3):260-7. doi: 10.1007/BF02895121.
PubMed 11211851Youssef NN, Langseder AL, Verga BJ, Mones RL, Rosh JR. Chronic childhood constipation is associated with impaired quality of life: a case-controlled study. J Pediatr Gastroenterol Nutr. 2005 Jul;41(1):56-60. doi: 10.1097/01.mpg.0000167500.34236.6a.
PubMed 15990631
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling
- ClinicalTrials.gov ID
- NCT00677508
- Acronym / sponsor ID
- CHW 05/154
- Conditions
- Constipation, Fecal Incontinence
- Keywords
- Constipation, Fecal incontinence, Quality of life, Health related quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc., University of South Alabama, Boston Children's Hospital, Ohio State University, University of Texas Southwestern Medical Center
- Study start
- Sep 2005 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 14 May 2008 (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.
We propose to develop parent and child disease-specific instruments to assess health related quality of life (HRQoL) in children with constipation and fecal incontinence.
Detailed description
Chronic constipation is a common problem in childhood, accounting for almost 3% of consultations in pediatric practice. In many children constipation is accompanied by overflow soiling (fecal incontinence). This condition often gives rise to behavioral, social, and emotional problems.
We plan to develop a disease-specific instrument to assess HRQoL in children with constipation and fecal incontinence. We hypothesize that HRQoL is worse in children with fecal incontinence compared to children with constipation but no fecal incontinence. The instrument will involve both parent and child self-reporting measures and will enable researchers to evaluate how disease and treatment strategies impact both child and parent perceptions of quality of life. In the long run this will enable physicians to develop a child friendly approach to management of chronic constipation and fecal incontinence.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| C FR | – | –Children with constipation and fecal incontinence. |
| C | – | –Children with constipation but without fecal incontinence. |
| P-C FR | – | –Parents of children with constipation and/or fecal incontinence. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children will be recruited from the Constipation Clinic at Children's Hospital of Wisconsin, as well as four coolaborating sites.
Key inclusion criteria (20 listed)
- Age 2-18 years
- Child and parents fluent in English
- Child must meet one of the following criteria;
- Constipation and fecal incontinence: must include 2 or more of the following in a child with insufficient criteria for a diagnosis of IBS (criteria fulfilled at least once per week for at least 2 months before diagnosis in a child over 4 years of age and for at least one month in a child less than 4 years of age):
- Two or fewer defecations in the toilet per week
Key exclusion criteria (3 listed)
- Children with developmental delays and children over 12 years of age who are unable to understand the questionnaires.
- Associated chronic disease which may have an impact on quality of life such as cerebral palsy, spine deformity or malformations, learning difficulties, severe mental illness, celiac disease, etc.
- Child and parents not fluent in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To develop and validate child and parent questionnaires to assess HRQoL of children with chronic constipation and fecal incontinence.
Time frame: 2 years
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 30 Apr 2020.
- Background: PubMed 9248318Treurniet HF, Essink-Bot ML, Mackenbach JP, van der Maas PJ. Health-related quality of life: an indicator of quality of care? Qual Life Res. 1997 May;6(4):363-9. doi: 10.1023/a:1018435427116.
- Background: PubMed 11211851Brooks RC, Copen RM, Cox DJ, Morris J, Borowitz S, Sutphen J. Review of the treatment literature for encopresis, functional constipation, and stool-toileting refusal. Ann Behav Med. 2000 Summer;22(3):260-7. doi: 10.1007/BF02895121.
- Background: PubMed 15990631Youssef NN, Langseder AL, Verga BJ, Mones RL, Rosh JR. Chronic childhood constipation is associated with impaired quality of life: a case-controlled study. J Pediatr Gastroenterol Nutr. 2005 Jul;41(1):56-60. doi: 10.1097/01.mpg.0000167500.34236.6a.
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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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.
Manu Sood, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation and Fecal Incontinence, run by Medical College of Wisconsin at 1 site in United States.
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 20 inclusion and 3 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 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
To develop and validate child and parent questionnaires to assess HRQoL of children with chronic constipation and fecal incontinence. (time frame: 2 years). 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 NCT00677508, which also lists 3 linked publications.
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 30 Apr 2020.