Constipation and Gut Transit in DMD Patients

NCT ID: NCT01890616

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-01

Study Completion Date

2015-07-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Constipation DMD

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Motility

This arm will ingest the SmartPill.

SmartPill ingestion

Intervention Type DEVICE

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

Interventions

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SmartPill ingestion

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ajay Kaul, MD

Role: STUDY_CHAIR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2013-1312

Identifier Type: -

Identifier Source: org_study_id

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