The Intestinal Function in People With Prader-Willi Syndrome

Constipation Clinical Trial

Official title:

The Intestinal Function in People With Prader-Willi Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523288
• Other study ID #: PWS-1051
• Status: Completed
• Phase: N/A
• First received: January 30, 2012
• Last updated: January 31, 2012
• Start date: February 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Constipation
• Incontinence
• Prader-Willi Syndrome
• Syndrome

Locations

Country	Name	City	State
Denmark	Centre of Rare Diseases, Pediatric department, Aarhus University Hospital Skejby	Aarhus	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colonic Transit time	Measured ad modum Göteborg	6 days	No
Primary	Rectal diameter	measured by ultrasound scan	1 day	No