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

NCT02021084 | Withdrawn

• 1 other identifier: 0173-13-RMB CTIL
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Familial Mediterranean Fever (FMF )

Keywords

Familial Mediterranean Fever (FMF), probiotics

Outcome Measures

Primary Outcomes (1)

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

  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 : 1. Number of days with at least one episode of loose stool. 2. Number of days with abdominal pain not related to FMF attacks.

  6 months after enrollment assumed to be at 12/2014

Secondary Outcomes (1)

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

  6 months after enrollment assumed to be at 12/2014

Study Arms (2)

placebo, response, adverse effect

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

probiotic, response, adverse effect

ACTIVE COMPARATOR

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.

Dietary Supplement: probiotic

Interventions

probiotic DIETARY_SUPPLEMENT

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.

Also known as: Bio 25

probiotic, response, adverse effect

Placebo DIETARY_SUPPLEMENT

Placebo group - patients will received placebo patients will received one capsule a day for 3 month.

placebo, response, adverse effect

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical diagnosis of FMF
• Age 5-18 years
• Colchicine therapy
• Gastrointestinal adverse effect or recurrent FMF attacks on colchicine

You may not qualify if:

• Severe immune deficiency

Sponsors & Collaborators

• Rambam Health Care Campus: lead

MeSH Terms

Conditions

Familial Mediterranean Fever

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Butbul Yonatan, M.D

  Rambam medical center, Mayers childrens hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Butbul Aviel Yonatan

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: December 27, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 7, 2016

Record last verified: 2016-10