ConstipationNCT01890616
Constipation and Gut Transit in DMD Patients
An observational study of Constipation and DMD, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Constipation, DMD
- What is being tested?
- SmartPill ingestion
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2013to 1 Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: DMD patients 5-18 yr of age who are seen in a large interdisciplinary DMD center.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: 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.
Read the 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
- Conditions
- Constipation, DMD
- Being tested
- SmartPill ingestion
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartPill ingestionDevice
The participant would ingest the SmartPill and wear the data receiver for up to 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Motility | This arm will ingest the SmartPill. Receives: Device: SmartPill ingestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI transit times
Gi transit times will be computed by an investigator.
Measured: up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study start1 May 2013
- Primary completion1 Jul 2015
- Study completion1 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ajay Kaul, MD, Study chair, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890616
- Sponsor's protocol ID
- 2013-1312
- Status last verified
- Sep 2020
- First submitted
- 26 Jun 2013
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constipation and Gut Transit in Duchenne Muscular Dystrophy Patients
- ClinicalTrials.gov ID
- NCT01890616
- Acronym / sponsor ID
- 2013-1312
- Conditions
- Constipation, DMD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 1 Jul 2015 (actual)
- First posted
- 2 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motility | – | Device: SmartPill ingestionThis arm will ingest the SmartPill. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- DMD patients 5-18 yr of age who are seen in a large interdisciplinary DMD center.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartPill ingestionThe participant would ingest the SmartPill and wear the data receiver for up to 5 days. | Device | Motility |
Primary outcome
GI transit times
Time frame: up to 5 days
Gi transit times will be computed by an investigator.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay Kaul, MD study chair
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation and DMD, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GI transit times (time frame: up to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.