The Intestinal Function in People With Prader-Willi Syndrome
|ClinicalTrials.gov Identifier: NCT01523288|
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : February 1, 2012
|Condition or disease|
|Prader-Willi Syndrome Constipation Incontinence|
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 Type :||Observational|
|Actual Enrollment :||21 participants|
|Observational Model:||Case Control|
|Official Title:||The Intestinal Function in People With Prader-Willi Syndrome|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Control group for ultrasound scan
- Colonic Transit time [ Time Frame: 6 days ]Measured ad modum Göteborg
- Rectal diameter [ Time Frame: 1 day ]measured by ultrasound scan
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523288
|Centre of Rare Diseases, Pediatric department, Aarhus University Hospital Skejby|
|Aarhus, Aarhus N, Denmark, 8200|
|Principal Investigator:||Louise K Frandsen, Stud.med||Centre of Rare Diseases, Pediatrics department, Aarhus University Hospital Skejby|
|Study Chair:||Stense Farholt, Ph.D||Centre for Rare Diseases, Pediatrics department, Aarhus University Hospital Skejby|
|Study Chair:||Klaus Krogh, DMSc||Medical Hepato-gastroenterological department, Aarhus University Hospital, Aarhus Sygehus|
|Study Chair:||Iben M Jønsson, Ph.D||Pediatrics department, Aarhus University Hospital Skejby|
|Study Chair:||Jens B Froekjaer, PhD||Department of Radiology, Aalborg Hospital|