Clinical trial NCT02021084: The Effect of Probiotics on Response to Therapy and on Adverse Effect in Patients Treated With Colchicine for Familial Mediterranean Fever.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Familial Mediterranean Fever (FMF )
Keywords: Familial Mediterranean Fever (FMF), probiotics
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The number of gastrointestinal adverse effect related to colchicine therapy after adding probiotics to colchicine therapy.
timeFrame: 6 months after enrollment assumed to be at 12/2014
Secondary outcomes:
measure: Number of FMF attacks after adding the probiotics to the colchicine therapy
timeFrame: 6 months after enrollment assumed to be at 12/2014
Other outcomes:
Locations:
Study officials:
affiliation: Rambam medical center, Mayers childrens hospital
name: Butbul Yonatan, M.D
role: PRINCIPAL_INVESTIGATOR
References: