Gluten-related Disorders in Familial Mediterranean Fever Patients
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ClinicalTrials.gov Identifier: NCT03563300 |
Recruitment Status :
Completed
First Posted : June 20, 2018
Last Update Posted : April 17, 2019
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Condition or disease | Intervention/treatment | Phase |
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Not-celiac Wheat Sensitivity (NCWS) Familial Mediterranean Fever (FMF) | Other: Wheat flour Other: Placebo Comparator | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Diagnostic |
Official Title: | Gluten-related Disorders in Patients Affected With Familial Mediterranean Fever |
Actual Study Start Date : | September 1, 2018 |
Actual Primary Completion Date : | March 1, 2019 |
Actual Study Completion Date : | April 1, 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Wheat flour
Wheat flour will be administered blindly versus placebo for 7 days
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Other: Wheat flour
Wheat flour will be administered once daily for 7 days
Other Name: Active Comparator |
Placebo Comparator: Rice flour
Placebo will be administered blindly versus wheat flour for 7 days
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Other: Placebo Comparator
Placebo will be administered blindly versus wheat flour for 7 days
Other Name: Rice flour |
- Fibromyalgia symptoms evaluation [ Time Frame: Change from baseline at 1 week ]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 evaluation [ Time Frame: Change from baseline at 1 week ]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
- Leukocytes cell surface antigens expression [ Time Frame: Change from baseline at 1 week ]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
- Cytokines production [ Time Frame: Change from baseline at 1 week ]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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult patients, both genders, with age between 18-65 years, affected with FMF, diagnosed according to clinical criteria designed by Livneh et al ("Tel-Hashomer" criteria), self-reporting a relationship between their symptoms (especially gastrointestinal) and gluten assumption, improving on a gluten-free diet and worsen on a gluten containing diet
- Patients testing negative for celiac disease (anti-tTG and EMA negative, and with biopsy Marsh 0-1) and wheat allergy (serum specific IgE for wheat negative)
Exclusion Criteria:
- Subjects diagnosed with celiac disease (positive anti-tTG and/or EMA, and positive histology, with Marsh 2 or above);
- Subjects diagnosed with wheat allergy (positive serum specific IgE for wheat)
- Subjects with Inflammatory Bowel Diseases (Crohn's disease or ulcerative colitis)
- Subjects with Helicobacter pylori infection and other gastrointestinal infection
- Pregnancy

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): NCT03563300
Italy | |
Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca | |
Sciacca, Agrigento, Italy, 92019 | |
Department of Internal Medicine, University Hospital of Palermo | |
Palermo, Italy, 90129 |
Principal Investigator: | Antonio Carroccio, PhD | University of Palermo |
Responsible Party: | Pasquale Mansueto, Clinical Professor, University of Palermo |
ClinicalTrials.gov Identifier: | NCT03563300 |
Other Study ID Numbers: |
ACPM21 |
First Posted: | June 20, 2018 Key Record Dates |
Last Update Posted: | April 17, 2019 |
Last Verified: | April 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Brucellosis Familial Mediterranean Fever Hereditary Autoinflammatory Diseases Fever Body Temperature Changes Gram-Negative Bacterial Infections |
Bacterial Infections Bacterial Infections and Mycoses Infections Genetic Diseases, Inborn Skin Diseases, Genetic Skin Diseases |