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

Arm I will be inoculated with the human hookworm necator americanus at weeks 0 and 12.

Arm II participants will receive and identical sham-inoculums comprising a diluted amount of 0.2ml McIlhenny & Co Tabasco Pepper Sauce®

Celiac Disease

10 necator americanus larvae will be inoculated at week 0 with a further 5 larvae inoculated at week 12

Necator americanus

A diluted amount of McIlhenny & Co Tabasco Pepper Sauce will be applied via a gauze dressing at weeks 0 and 12.

Sham inoculation

Queensland Institute of Medical Research

Princess Alexandra Hospital

Logan Hospital

Inoculating Celiac Disease Patients With the Human Hookworm Necator Americanus: Evaluating Immunity and Gluten-sensitivity

A Phase 2a, Randomized, Double Blinded, Placebo Controlled, Study Evaluating Immunity and Gluten-sensitivity by Inoculating Celiac Disease Patients With the Human Hookworm Necator Americanus.

gluten/fever

Gluten-related Disorders in Familial Mediterranean Fever Patients

Inoculating Celiac Disease Patients With the Human Hookworm Necator Americanus: Evaluating Immunity and Gluten-sensitivity

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