Constipation and Gut Transit in DMD Patients

Constipation and Gut Transit in Duchenne Muscular Dystrophy Patients

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.

Study Overview

• Status: Completed
• Conditions: Constipation; DMD
• Intervention / Treatment: Device: SmartPill ingestion

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

DMD patients 5-18 yr of age who are seen in a large interdisciplinary DMD center.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Motility; This arm will ingest the SmartPill.	Device: SmartPill ingestion; The participant would ingest the SmartPill and wear the data receiver for up to 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GI transit times	Gi transit times will be computed by an investigator.	up to 5 days

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Study Chair: Ajay Kaul, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 26, 2013
• First Submitted That Met QC Criteria: June 27, 2013
• First Posted (Estimate): July 2, 2013

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 11, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 2013-1312