The Effect of Probiotics on Response to Therapy and on Adverse Effect in Patients Treated With Colchicine for Familial Mediterranean Fever.

Study Overview
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Brief Summary
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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.

Conditions
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Familial Mediterranean Fever (FMF )

Intervention / Treatment
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* Dietary Supplement: probiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo, response, adverse effect<br>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 gastrointestinal adverse effect or partial response to colchicine.in the first 3 month patients will be followed with no interventions 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 patients that will received placebo arm one and patients that will receive probiotics arm two. | Dietary Supplement: Placebo<br>* Placebo group - patients will received placebo patients will received one capsule a day for 3 month.<br>|
| Active Comparator: probiotic, response, adverse effect<br>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 gastrointestinal adverse effect or partial response to colchicine.in the first 3 month patients will be followed with no interventions 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 patients that will received placebo arm one and patients that will receive probiotics arm two. | Dietary Supplement: probiotic<br>* Probiotics group - patients will received probiotics Bio -25 including 11 types of bacteria total of 25 billion germs in each capsule, patients will received one capsule a day for 3 month.<br>* Other names: Bio 25;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Familial Mediterranean Fever (FMF), probiotics