Familial Mediterranean Fever (FMF )NCT02021084
The Effect of Probiotics on Response to Therapy and on Adverse Effect in Patients Treated With Colchicine for Familial Mediterranean Fever.
A study testing probiotic in people with Familial Mediterranean Fever (FMF ), run by Rambam Health Care Campus.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Familial Mediterranean Fever (FMF )
- What is being tested?
- probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of FMF
- Age 5-18 years
- Colchicine therapy
- Gastrointestinal adverse effect or recurrent FMF attacks on colchicine
Who cannot join
- Severe immune deficiency
About this study
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.
Read more
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 )
- Being tested
- probiotic, Placebo
- Keywords
- Familial Mediterranean Fever (FMF), probiotics
- Medical subject headings
- Familial Mediterranean Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticDietary supplement
Also called Bio 25
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.
PlaceboDietary supplement
Placebo group - patients will received placebo patients will received one capsule a day for 3 month.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 :
- Number of days with at least one episode of loose stool.
- Number of days with abdominal pain not related to FMF attacks.
Measured: 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
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 .
Measured: 6 months after enrollment assumed to be at 12/2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Why it stopped: no patient enroled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Mediterranean Fever (FMF )Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yonatan butbul MD, Rambam Health Care Campus
- Investigators
- Butbul Yonatan, M.D, Principal investigator, Rambam medical center, Mayers childrens hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021084
- Sponsor's protocol ID
- 0173-13-RMB CTIL
- Status last verified
- Oct 2016
- First submitted
- 29 Oct 2013
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotics on Response to Therapy and on Adverse Effect in Patients Treated With Colchicine for Familial Mediterranean Fever.
- ClinicalTrials.gov ID
- NCT02021084
- Acronym / sponsor ID
- 0173-13-RMB CTIL
- Conditions
- Familial Mediterranean Fever (FMF )
- Keywords
- Familial Mediterranean Fever (FMF), probiotics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patient enroled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo, response, adverse effect | Placebo comparator | Dietary Supplement: Placebochildren (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. |
| probiotic, response, adverse effect | Active comparator | Dietary Supplement: probioticchildren (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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of FMF
- Age 5-18 years
- Colchicine therapy
- Gastrointestinal adverse effect or recurrent FMF attacks on colchicine
Key exclusion criteria (1 listed)
- Severe immune deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probioticAlso: Bio 25Probiotics 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. | Dietary supplement | probiotic, response, adverse effect |
| PlaceboPlacebo group - patients will received placebo patients will received one capsule a day for 3 month. | Dietary supplement | placebo, response, adverse effect |
Primary outcome
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.
1 secondary outcome
Number of FMF attacks after adding the probiotics to the colchicine therapy
Time frame: 6 months after enrollment assumed to be at 12/2014
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
Related trials for Familial Mediterranean Fever (FMF )
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
RecruitingPhase 3
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Behçet's Disease, Juvenile Psoriatic Arthritis
Not yet recruitingPhase 3
Goflikicept for Resolution and Prevention of Attacks in Pediatric and Adolescent Patients With Colchicine-Resistant or Colchicine-Intolerant Familial Mediterranean Fever
Familial Mediterranean Fever, FMF
Not yet recruitingObservational study
Genotype and Phenotype in Pediatric Familial Mediterranean Fever
Familial Mediterranean Fever
Not yet recruitingObservational study
Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Butbul Yonatan, M.D principal investigator
Rambam medical center, Mayers childrens hospital
Questions about this trial
What is this clinical trial studying?
A study testing probiotic in people with Familial Mediterranean Fever (FMF ), run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016.