Wheat flour will be administered blindly versus placebo for 7 days

Placebo will be administered blindly versus wheat flour for 7 days

Not-celiac Wheat Sensitivity (NCWS)

Familial Mediterranean Fever (FMF)

Wheat flour will be administered once daily for 7 days

Wheat flour

Placebo Comparator

Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca

Department of Internal Medicine, University Hospital of Palermo

Gluten-related Disorders in Familial Mediterranean Fever Patients

Gluten-related Disorders in Patients Affected With Familial Mediterranean Fever

Fibromyalgia symptoms of patients, evaluated by the International Severity Scoring System for Familial Mediterranean Fever (ISSF), will be scored before and after 1 week of wheat (or placebo) ingestion

Gastrointestinal symptoms of patients, evaluated by the Gastrointestinal Symptom Rating Scale (GSRS), will be scored before and after 1 week of wheat (or placebo) ingestion

There will be evaluated some leukocytes cell surface antigens expression, i.e. CD45, CD56, CD117, NKp44, CD3, CD19, and CD14, from peripheral blood mononuclear cells and rectal mucosal lymphocytes before and after 1 week of wheat (or placebo) ingestion

There will be evaluated some cytokines production, i.e. IFN-γ, TNF-α, IL-22, IL-17, and T-bet, from peripheral blood mononuclear cells and rectal mucosal lymphocytes before and after 1 week of wheat (or placebo) ingestion

Pasquale Mansueto

Clinical Professor

University of Palermo

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.

Familial Mediterranean Fever (FMF )

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.

probiotic

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

Placebo

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

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.

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 .

yonatan butbul MD

Butbul Aviel Yonatan

Rambam Health Care Campus

Secondary (AA) Amyloidosis

Rheumatoid Arthritis

Nephrotic Syndrome

Familial Mediterranean Syndrome

Kidney Diseases

Gastrointestinal Diseases

NC-503 (Anti-amyloidotic (AA) Agent)

Indiana University School of Medicine, Department of Pathology and Laboratory Medicine,

Boston Medical Center, Renal Division

Mayo Clinic

Mount Sinai Medical Center

Rheumatism Foundation Hospital

Centre Hospitalier du Mans, Service de Rhumatologie

Hôpital Claude Huriez, Service de médecine Interne, Clinique Médicale A

Hôpital Cochin, Centre de Recherche et d'Explorations Fonctionnelles

Bnai Zion Medical Center

Heller Institute of Medical Research, Sheba Medical Center

Italian Group for Systemic Amyloidosis, Biotechnology Research Laboratories, IRCCS Policlinico San Matteo, Internal Medicine and Medical Oncology

Vilnius University Hospital

University Hospital Groningen, Department of Medicine, Division of Rheumatology

Instytut Reumatologiczny

Okregowy Szpital Kolejowy, Zaklad Reumatologii

Institute of Rheumatology RAMS

Regional Hospital No. 1

Hospital Universitario Germans Trias I Pujol, Servicio de Reumatologia

Hospital Clinic I Provincial de Barcelona, Jefe del Departamento de Reumatologia

Ciutad Sanitària y Universitària de Bellvitge, Servicio de Reumatologia, Hospitalet de Llobregat

Hospital Clinico San Carlos de Madrid, Servicio de Reumatologia

Cerrehpasa Tip Fakultesi

Istanbul Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology

Marmara University Medical School Hospital, Department of Rheumatology

Royal Free and University College Medical School, Department of Medicine, National Amyloidosis Centre

Gartnavel General Hospital

Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis

A Phase II/III Study of the Safety and Efficacy of NC-503 in Patients Suffering From Secondary (AA) Amyloidosis

familial mediterranean fever/إسهال

Gluten-related Disorders in Familial Mediterranean Fever Patients

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

Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis

قاعدة بيانات الأعشاب الطبية الأكثر اكتمالا التي يدعمها العلم