- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02021084
The Effect of Probiotics on Response to Therapy and on Adverse Effect in Patients Treated With Colchicine for Familial Mediterranean Fever.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo, response, adverse effect
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.
|
Placebo group - patients will received placebo patients will received one capsule a day for 3 month.
|
Active Comparator: probiotic, response, adverse effect
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.
|
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.
Other Names:
|
What is the study measuring?
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.
Time Frame: 6 months after enrollment assumed to be at 12/2014
|
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 :
|
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
Time Frame: 6 months after enrollment assumed to be at 12/2014
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Butbul Yonatan, M.D, Rambam medical center, Mayers childrens hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0173-13-RMB CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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