Inflammatory Bowel Disease
Conditions
Keywords
Inflammatory Bowel Disease, Anemia, Anti-TNF alpha theray, Ferrisat perfusion
Brief summary
Anemia is the the most frequently extradigestive symptom for Inflammatory Bowel Disease. This is due to iron deficiency and inflammation. Most of treatments aim to control inflammation using anti-TNF alpha therapy which should theorically reduce anemia. The aim of the study is to show that perfusion of iron associated to anti-TNF therapy should reduce anemia and improve quality of life of patients.
Interventions
DRUGFERRISAT
A single infusion of 50 mg/ml of Ferrisat during inclusion visit.
DRUGPLACEBO
A single infusion of Glucose 5% solution during inclusion visit
Sponsors
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than 18 years * Crohn's disease or Ulcerative Colitis defined according to the usual endoscopic, histological, and radiological criteria * Under anti-TNF therapy or indication for starting an anti-TNF therapy * Anemia defined according to World Health Organization (Hemoglobin under 13g/dl for man and Hemoglobin under 12g/dl for woman) * Iron deficiency anemia defined as: * Ferritinemia under 100 if C-Reactive Protein under normal value OR - Ferritinemia between 30 and 100 if C-Reactive Protein above normal value
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of hemoglobin | 6 weeks after inclusion | Efficacy of one-shot perfusion of Ferrisat (Iron supplementation) |
Secondary
| Measure | Time frame |
|---|---|
| Tolerance of Ferrisat | At Inclusion |
| Improvement of quality of life | 6 weeks after perfusion |
Countries
France
Outcome results
None listed