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CompletedNCT04384354DIGDUpdated May 12, 2020

Digestive Events in Duchenne Muscular Dystrophy Patients

An observational study in Duchenne Muscular Dystrophy, sponsored by Centre d'Investigation Clinique et Technologique 805. Completed at 1 site in France. Open to male participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2020-05-12.

Sponsored by Centre d'Investigation Clinique et Technologique 805 · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
15 Years and older
Sex
Male
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Study summary

Relation between clinical and genetic features and acute digestive events in Duchenne muscular dystrophy patients

Read the detailed description

Clinical Data of the disease Digestive events (pseudo occlusion, gastrostomy, cholecystectomy) Nutritionnal parameters Genetic of dystrophin (approved genetic nationnal Data base, CHU Cochin, Paris France)

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Conditions studied

  • Duchenne Muscular Dystrophy

Keywords

  • pseudo occlusion
  • gastrostomy
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In context

Muscular Dystrophies

548 studies on the registry are indexed under Muscular Dystrophies; 89 are open to participants now.

This study's enrollment of 200 is above the median of 69 across 179 observational studies indexed under Muscular Dystrophies.

Browse Muscular Dystrophies studies →

Lead sponsor

Centre d'Investigation Clinique et Technologique 805 is the lead sponsor of 74 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years and older
Sexes eligible
Male
Sampling method
Non-probability sample

Study population

Duchenne muscular dystrophy patients

Inclusion criteria

  • all Duchenne muscular dystrophy patients in our center

Exclusion criteria

Exclusion Criteria:

  • none
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Incidence of digestive events

    Clinical parameters (yes or no): gastrostomy, bowel occlusion, acute gastric paresia, biliary complication

    Time frame: 11 years

  2. Prevalence of digestive events

    Clinical parameters (yes or no) : gastrostomy, bowel occlusion, acute gastric paresia, biliary complication

    Time frame: 11 years

  3. Risk factors for digestive events (1)

    age (years)

    Time frame: 11 years

  4. Risk factors for digestive events (2)

    pulmonary functional tests (vital capacity in ml/kg)

    Time frame: 11 years

  5. Risk factors for digestive events (3)

    echocardiography parameters (LVEF: left ventricular ejection fraction in %)

    Time frame: 11 years

  6. Risk factors for digestive events (4)

    residual dystrophin level (Western blot and/or immunohistochemistry in muscle)

    Time frame: 11 years

  7. Risks factors for digestive events (5)

    genetic parameters (type of mutation, functional domain of altered dystrophin)

    Time frame: 11 years

Secondary outcomes

  1. Nutritional status (1)

    Weigh (kg) and height (in m) agregated in BMI (kg/m\^2)

    Time frame: 11 years

  2. Nutritional status (2)

    albuminemia in g/L

    Time frame: 11 years

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Study locations

1 site
  • CICIT805
    Garches, 92380, France
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References and documents

Individual participant data

Plan to share: Undecided — All clinician and biologist involved in the follow-up of these patients

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04384354
Lead sponsor
Centre d'Investigation Clinique et Technologique 805
Responsible party
Crenn (Professor, Centre d'Investigation Clinique et Technologique 805) — Principal investigator
First posted
May 12, 2020
Start date
Jan 2007
Primary completion
Dec 2018
Completion
Apr 2019
Last update
May 12, 2020

Study contacts

CICIT805 Garches
study chair · APHP/UVSQ

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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