Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome

Down Syndrome With and Without Auto Immune Abnormalities Clinical Trial

— IMMUTRI  

Official title:

Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041469
• Other study ID #: IJL-IMM-EP10
• Status: Completed
• Phase: N/A
• First received: December 30, 2009
• Last updated: March 21, 2012
• Start date: November 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2009
• Source: Institut Jerome Lejeune
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to identify biological data linked to auto immune abnormalities associated with Down Syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 36 Years

Eligibility

Inclusion Criteria:

• Free and complete trisomy 21

• aged between 8 and 36 years

• biological or clinical signs of auto-immune disorder (group 1)

• no sign of auto-immune disorder (group 2)

Exclusion Criteria:

• any antimitotic or immune depressing treatment during the last 6 months

• Current infectious disease

• Corticosteroid therapy in the last 3 weeks

• pregnancy

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Congenital Abnormalities
• Down Syndrome
• Down Syndrome With and Without Auto Immune Abnormalities
• Syndrome

Locations

Country	Name	City	State
France	Institut Jerome Lejeune	Paris
France	Laboratoire d'Immunologie Biologique (Unité INSERM U580)	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Institut Jerome Lejeune	Fondation Jérôme Lejeune

Country where clinical trial is conducted

France, 

References & Publications (1)

Friedman DL, Kastner T, Pond WS, O'Brien DR. Thyroid dysfunction in individuals with Down syndrome. Arch Intern Med. 1989 Sep;149(9):1990-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Auto-antibodies dosage		at enrolment	No
Primary	specific lymphocytes populations count		at enrolment	No