Prader-Willi SyndromeNCT01523288
The Intestinal Function in People With Prader-Willi Syndrome
An observational study of Prader-Willi Syndrome and Constipation, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The projects aim is to investigate the intestinal function of patients suffering from Prader-Willi Syndrome. The methods used are ultrasonographic measurement of the rectal diameter and gastrointestinal transit time Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prader-Willi Syndrome, Constipation, Incontinence
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to Jan 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Prader-Willi Syndrome
Who may be able to join
- age above 18
- >14 days since last antibiotic treatment
- >14 days since last laxative treatment
- PWS confirmed genetically
Who cannot join
- previous abdominal surgery (except appendectomy or haemorrhoidectomy
- patient not capable of understanding the information
- treatment with eltroxin or antipsychotic medication
- pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Centre of Rare Diseases, Pediatric department, Aarhus University Hospital Skejby
Aarhus, Aarhus N, 8200
About this study
The projects aim is to investigate the intestinal function of patients suffering from Prader-Willi Syndrome. The methods used are ultrasonographic measurement of the rectal diameter and gastrointestinal transit time
Read the detailed description
Prader-Willi Syndrome (PWS) is a congenital genetical disease characterized by moderate retardation, food-seeking behavior and a serious risk of developing health threatening overweight, low stature, abnormal body composition and a lack of growth- and sex-hormones. They can not live an independent life and are reliant of help from care personnel.
People with PWS react abnormally to signals from their own bodies. E.g. they have a reduced sense of pain and can have a lacking urge to urination despite a full bladder. Most of the patients also have a relatively slow pulse, which can be consistent with a dysfunction in the nervous system (the parasympathetic nervous system) which also has large significance for the bladder- and bowel function.
The Intestinal function in people with PWS is a sparse described subject, which has not been systematically examined in scientific context. We therefore want to examine whether the bowel function in people with PWS are different from the bowel function in healthy people.
The subject is elucidated by a medical examination, a questionnaire, a registration of toilet habits, a measurement of the rectal diameter by an ultrasound scan and a measurement of the colonic transit time.
The results will be compared to findings in normal healthy people. Because no normal material exists for rectal diameter measured by ultrasound, we will establish one.
The result of the project will increase our knowledge of possible bowel dysfunctions such as constipation, in people with PWS and can immediately lead to improved care for and optimized treatment of the patients.
- Conditions
- Prader-Willi Syndrome, Constipation, Incontinence
- Medical subject headings
- Prader-Willi Syndrome, Constipation
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 |
|---|---|---|
| Prader-Willi patients | Not described | |
| Control group | Control group for ultrasound scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic Transit time
Measured ad modum Göteborg
Measured: 6 days
Rectal diameter
measured by ultrasound scan
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startFeb 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prader-Willi SyndromeStudies 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
- Observational
- Observational model
- Case-control
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Kuhlmann Frandsen, Aarhus University Hospital
- Investigators
- Louise K Frandsen, Stud.med, Principal investigator, Centre of Rare Diseases, Pediatrics department, Aarhus University Hospital SkejbyStense Farholt, Ph.D, Study chair, Centre for Rare Diseases, Pediatrics department, Aarhus University Hospital SkejbyKlaus Krogh, DMSc, Study chair, Medical Hepato-gastroenterological department, Aarhus University Hospital, Aarhus SygehusIben M Jønsson, Ph.D, Study chair, Pediatrics department, Aarhus University Hospital SkejbyJens B Froekjaer, PhD, Study chair, Department of Radiology, Aalborg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523288
- Sponsor's protocol ID
- PWS-1051
- Status last verified
- Jan 2012
- First submitted
- 30 Jan 2012
- Last updated
- 1 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intestinal Function in People With Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT01523288
- Acronym / sponsor ID
- PWS-1051
- Conditions
- Prader-Willi Syndrome, Constipation, Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 1 Feb 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.
The projects aim is to investigate the intestinal function of patients suffering from Prader-Willi Syndrome. The methods used are ultrasonographic measurement of the rectal diameter and gastrointestinal transit time
Detailed description
Prader-Willi Syndrome (PWS) is a congenital genetical disease characterized by moderate retardation, food-seeking behavior and a serious risk of developing health threatening overweight, low stature, abnormal body composition and a lack of growth- and sex-hormones. They can not live an independent life and are reliant of help from care personnel.
People with PWS react abnormally to signals from their own bodies. E.g. they have a reduced sense of pain and can have a lacking urge to urination despite a full bladder. Most of the patients also have a relatively slow pulse, which can be consistent with a dysfunction in the nervous system (the parasympathetic nervous system) which also has large significance for the bladder- and bowel function.
The Intestinal function in people with PWS is a sparse described subject, which has not been systematically examined in scientific context. We therefore want to examine whether the bowel function in people with PWS are different from the bowel function in healthy people.
The subject is elucidated by a medical examination, a questionnaire, a registration of toilet habits, a measurement of the rectal diameter by an ultrasound scan and a measurement of the colonic transit time.
The results will be compared to findings in normal healthy people. Because no normal material exists for rectal diameter measured by ultrasound, we will establish one.
The result of the project will increase our knowledge of possible bowel dysfunctions such as constipation, in people with PWS and can immediately lead to improved care for and optimized treatment of the patients.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prader-Willi patients | – | – |
| Control group | – | –Control group for ultrasound scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Prader-Willi Syndrome
Key inclusion criteria (4 listed)
- age above 18
- >14 days since last antibiotic treatment
- >14 days since last laxative treatment
- PWS confirmed genetically
Key exclusion criteria (4 listed)
- previous abdominal surgery (except appendectomy or haemorrhoidectomy
- patient not capable of understanding the information
- treatment with eltroxin or antipsychotic medication
- pregnancy
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
Colonic Transit time
Time frame: 6 days
Measured ad modum Göteborg
Rectal diameter
Time frame: 1 day
measured by ultrasound scan
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 1 Feb 2012.
Related trials for Prader-Willi Syndrome
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A Study of CSTI-500 in Patients With Prader-Willi Syndrome
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Cerebellar TMS and Satiety in Prader-Willi Syndrome
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Enrolling by invitationObservational study
Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome
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Active, not recruitingPhase 1/2
A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
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Active, not recruiting
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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.
Louise K Frandsen, Stud.med principal investigator
Centre of Rare Diseases, Pediatrics department, Aarhus University Hospital Skejby
Stense Farholt, Ph.D study chair
Centre for Rare Diseases, Pediatrics department, Aarhus University Hospital Skejby
Klaus Krogh, DMSc study chair
Medical Hepato-gastroenterological department, Aarhus University Hospital, Aarhus Sygehus
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 Prader-Willi Syndrome and Constipation, run by Aarhus University Hospital at 1 site 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 4 inclusion and 4 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 1 Feb 2012. 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 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?
Colonic Transit time (time frame: 6 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2012.