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OpenTrials
Completed

NCT Number: NCT01890616

Constipation and Gut Transit in DMD 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.

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Key information

Conditions

Constipation DMD Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SmartPill ingestion

Device

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

Primary outcomes

  1. GI transit times

    Time frame: up to 5 days

    Gi transit times will be computed by an investigator.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Constipation and Gut Transit in Duchenne Muscular Dystrophy Patients

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 2, 2013
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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