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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

Page last updated: August 20, 2015

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