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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02021084
Recruitment Status : Withdrawn (no patient enroled)
First Posted : December 27, 2013
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
yonatan butbul MD, Rambam Health Care Campus

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.


Condition or disease Intervention/treatment Phase
Familial Mediterranean Fever (FMF ) Dietary Supplement: probiotic Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014


Arm Intervention/treatment
Placebo Comparator: placebo, response, adverse effect
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
Placebo group - patients will received placebo patients will received one capsule a day for 3 month.

Active Comparator: probiotic, response, adverse effect
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
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.
Other Name: Bio 25




Primary Outcome Measures :
  1. The number of gastrointestinal adverse effect related to colchicine therapy after adding probiotics to colchicine therapy. [ Time Frame: 6 months after enrollment assumed to be at 12/2014 ]

    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.


Secondary Outcome Measures :
  1. Number of FMF attacks after adding the probiotics to the colchicine therapy [ Time Frame: 6 months after enrollment assumed to be at 12/2014 ]

    The number of attacks will be measured 3 months before starting the intervention and after 3 months patients will received either placebo or probiotics .

    Attacks will defined as fever with one of the above : a. abdominal pain b.pleuritic chest pain c.arthritis d.erysipelas like .




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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021084


Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Butbul Yonatan, M.D Rambam medical center, Mayers childrens hospital
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Responsible Party: yonatan butbul MD, Butbul Aviel Yonatan, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02021084    
Other Study ID Numbers: 0173-13-RMB CTIL
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: October 2016
Keywords provided by yonatan butbul MD, Rambam Health Care Campus:
Familial Mediterranean Fever (FMF), probiotics
Additional relevant MeSH terms:
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Brucellosis
Familial Mediterranean Fever
Hereditary Autoinflammatory Diseases
Fever
Body Temperature Changes
Gram-Negative Bacterial Infections
Bacterial Infections
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases