Constipation and Gut Transit in DMD Patients

Constipation Clinical Trial

Official title:

Constipation and Gut Transit in Duchenne Muscular Dystrophy Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01890616
• Other study ID #: 2013-1312
• Status: Completed
• Start date: May 1, 2013
• Est. completion date: July 1, 2015

Study information

• Verified date: September 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this research study the investigators want to screen Duchenne Muscular Dystrophy (DMD) patients for signs and symptoms of constipation in patients over 18.

The investigators hypothesized:

• DMD patients have a high prevalence of constipation than in the general population.

• Prevalence of constipation will increase with age and with worsening functional status.

Description:

The following procedures will take place during the study.

Constipation Assessment:

• The patient will be asked to complete a questionnaire about any symptoms of constipation.

• A physician from the study team will perform an abdominal physical exam

• The patient will have routine x-rays that monitor for spine compression fractures. These films will also be used to assess stool content.

Clinical Information The following information will also be collected during the clinic visit ;

• Age at diagnosis and genetic mutation

• Age at loss of ambulation if applicable

• Medications

• Functional status

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 1, 2015
• Est. primary completion date: July 1, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a diagnosis of Duchenne Muscular Dystrophy (based on clinical presentation and verified by compatible muscle biopsy or known dystrophin gene mutation).

• Age greater than or equal to 18 years old

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Constipation
• DMD

Intervention

Device:
• SmartPill ingestion
The participant would ingest the SmartPill and wear the data receiver for up to 5 days.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GI transit times	Gi transit times will be computed by an investigator.	up to 5 days