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

Related Clinical Trial
Study of Colchicine Resistance in Familial Mediterranean Fever Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean Fever Central Sensitization in Familial Mediterranean Fever (FMF) Efficacy and Safety of RPH-104 for Resolution and Prevention of Recurring Attacks in Adult Subjects With Familial Mediterranean Fever With Resistance to or Intolerance of Colchicine Effects of Online Aerobic Exercise Training and Physical Activity Counseling in Juvenile Familial Mediterranean Fever Characterization of a Functional Test for Mediterranean Family Fever Screening – 2 Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis Heat Intolerance in the Group of FMF Patients Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients The Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With FMF Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission Tocilizumab for the Treatment of Familial Mediterranean Fever Controlled Ceasing of Colchicine Therapy in Familial Mediterranean Fever (FMF) Patients With Single MEFV (Mediterranean Fever) Gene Mutation The Effect of Probiotics on Response to Therapy and on Adverse Effect in Patients Treated With Colchicine for Familial Mediterranean Fever. A Diagnostic Test for Familial Mediterranean Fever Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever Rilonacept for Treatment of Familial Mediterranean Fever (FMF)

Brief Title

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


Brief Summary

      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 Type

Interventional


Primary Outcome

The number of gastrointestinal adverse effect related to colchicine therapy after adding probiotics to colchicine therapy.

Secondary Outcome

 Number of FMF attacks after adding the probiotics to the colchicine therapy

Condition

Familial Mediterranean Fever (FMF )

Intervention

probiotic

Study Arms / Comparison Groups

 placebo, response, adverse effect
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

0

Start Date

December 2013

Completion Date

December 2014

Primary Completion Date

December 2014

Eligibility Criteria

        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
      

Gender

All

Ages

5 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Butbul Yonatan, M.D, , 



Administrative Informations


NCT ID

NCT02021084

Organization ID

0173-13-RMB CTIL


Responsible Party

Principal Investigator

Study Sponsor

Rambam Health Care Campus


Study Sponsor

Butbul Yonatan, M.D, Principal Investigator, Rambam medical center, Mayers childrens hospital


Verification Date

October 2016