The Intestinal Function in People With Prader-Willi Syndrome

Completed

• Conditions: Prader-Willi Syndrome; Constipation; Incontinence

• Registration Number: NCT01523288
• Lead Sponsor: Aarhus University Hospital

Brief 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

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 Timeline

• Study Start: 2011-02
• Status Verified: 2012-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Study First Submitted: 2012-01-30
• Study First Submitted QC: 2012-01-31
• Last Update Submitted: 2012-01-31
• Study First Posted: 2012-02-01
• Last Update Posted: 2012-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Colonic Transit time	6 days	Measured ad modum Göteborg
Rectal diameter	1 day	measured by ultrasound scan

Trial Locations

Locations (1)

Centre of Rare Diseases, Pediatric department, Aarhus University Hospital Skejby; 🇩🇰 Aarhus, Aarhus N, Denmark