The Intestinal Function in People With Prader-Willi Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Louise Kuhlmann Frandsen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01523288
First received: January 30, 2012
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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


Condition
Prader-Willi Syndrome
Constipation
Incontinence

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: The Intestinal Function in People With Prader-Willi Syndrome

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Colonic Transit time [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    Measured ad modum Göteborg

  • Rectal diameter [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    measured by ultrasound scan


Enrollment: 21
Study Start Date: February 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Prader-Willi patients
Control group
Control group for ultrasound scan

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients with Prader-Willi Syndrome

Criteria

Inclusion Criteria:

  • age above 18
  • >14 days since last antibiotic treatment
  • >14 days since last laxative treatment
  • PWS confirmed genetically

Exclusion Criteria:

  • previous abdominal surgery (except appendectomy or haemorrhoidectomy
  • patient not capable of understanding the information
  • treatment with eltroxin or antipsychotic medication
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523288

Locations
Denmark
Centre of Rare Diseases, Pediatric department, Aarhus University Hospital Skejby
Aarhus, Aarhus N, Denmark, 8200
Sponsors and Collaborators
Aarhus University Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Louise Kuhlmann Frandsen, Principal Investigator, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01523288     History of Changes
Other Study ID Numbers: PWS-1051
Study First Received: January 30, 2012
Last Updated: January 31, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Prader-Willi Syndrome
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on July 29, 2014