The Effect of Probiotics on Response to Therapy and on Adverse Effect in Patients Treated With Colchicine for Familial Mediterranean Fever.
Information source: Rambam Health Care Campus
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Familial Mediterranean Fever (FMF )
Intervention: probiotic (Dietary Supplement); Placebo (Dietary Supplement)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Rambam Health Care Campus Official(s) and/or principal investigator(s):
Butbul Yonatan, M.D, Principal Investigator, Affiliation: Rambam medical center, Mayers childrens hospital
Overall contact:
Yonatan Butbul, M.D, Phone: 972-54-3359151, Email: yonatanbutbul@gmail.com
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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
Eligibility
Minimum age: 5 Years.
Maximum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
Yonatan Butbul, M.D, Phone: 972-54-3359151, Email: yonatanbutbul@gmail.com Additional Information
Starting date: December 2013
Last updated: December 26, 2013
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