Familial Mediterranean Fever (FMF ) Clinical Trial
| Verified date | October 2016 |
| Source | Rambam Health Care Campus |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
Colchicine is the drug of choice to treat patients with Familial Mediterranean Fever (FMF ),
some of the patients treated with colchicine may suffer from gastrointestinal (GIT) adverse
effect such as diarrhea and abdominal pain especially in the higher dose.
5-10% of the patients with FMF that have been treated with colchicine may have partial or no
response to this therapy.
Aim of our study: the aim of our study is :.1to evaluate the efficacy of probiotics in
reducing the number of adverse effect in patients with FMF that are being treated with
colchicine and suffering from GIT adverse effect.
.2 To evaluate the efficacy of probiotics in reducing the number of FMF attacks in children
with FMF that has been treated with colchicine with only partial response.
Methods: the study will be done among children (5-17 years old) with FMF that are currently
followed in the pediatric rheumatology clinic at Mayer children hospital Israel Haifa that
are being treated with colchicine and suffering from either GIT adverse effect or partial
response to colchicine.
The study is design to be double blind placebo control, in the first 3 month patients will
be with no therapy and will be required to record all there FMF episodes and their GIT
adverse effect, in the second period the patients will be randomly divided into two groups
1.patients that will received placebo (group 1) and the 2. Probiotics group - patients will
received probiotics (Bio -25 including 11 types of bacteria L.acidophilus, B.bifidum ,
L.rhamnosus, L.lactis, L.casei, B.breve, B.thermophilus, B.longum, L.paracseis, L.plantarum,
B.infantis), both for three month, during this period patient will be required to record
their gastrointestinal symptoms and other symptoms that may be related to FMF.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 5 Years to 18 Years |
| Eligibility |
Inclusion Criteria: - Clinical diagnosis of FMF - Age 5-18 years - Colchicine therapy - Gastrointestinal adverse effect or recurrent FMF attacks on colchicine Exclusion Criteria: • Severe immune deficiency |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Rambam Health Care Campus |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The number of gastrointestinal adverse effect related to colchicine therapy after adding probiotics to colchicine therapy. | The number of gastrointestinal adverse effect will be measured 3 months before starting the intervention and after 3 months patients will received either placebo or probiotics the measures will be : Number of days with at least one episode of loose stool. Number of days with abdominal pain not related to FMF attacks. |
6 months after enrollment assumed to be at 12/2014 | No |
| Secondary | Number of FMF attacks after adding the probiotics to the colchicine therapy | The number of attacks will be measured 3 months before starting the intervention and after 3 months patients will received either placebo or probiotics . Attacks will defined as fever with one of the above : a. abdominal pain b.pleuritic chest pain c.arthritis d.erysipelas like . |
6 months after enrollment assumed to be at 12/2014 | No |