Bio-markers of Not-celiac Wheat Sensitivity

Launched by UNIVERSITY OF PALERMO · Jan 4, 2013

Keywords

ClinConnect Summary

This clinical trial is studying a condition called "not-celiac wheat sensitivity" (NCWS), which affects people who experience symptoms similar to irritable bowel syndrome (IBS) after eating wheat, but do not have celiac disease or a wheat allergy. The researchers want to understand what causes these symptoms and identify specific markers that could help diagnose NCWS. To do this, they will recruit adult patients who have seen their symptoms improve on a gluten-free diet and worsen when they eat gluten again.

Eligible participants for this study are adults between 18 and 65 years old who have IBS-like symptoms that improve when avoiding gluten and who have tested negative for celiac disease and wheat allergy. If you join the study, you will be randomly assigned to receive either wheat flour or a placebo (a harmless substance) for 15 days, and the researchers will monitor your symptoms before and after this period. They will also collect blood and tissue samples to look for possible markers of NCWS. This trial aims to enhance understanding of this condition and improve diagnosis for those affected.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients, both genders, with age between 18-65 years, with IBS-like symptoms, that improved 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 Type 1 Diabetes
• • Subjects with Inflammatory Bowel Diseases (Crohn's disease or ulcerative colitis)
• • Subjects with Helicobacter pylori infection and other gastrointestinal infection
• • Pregnancy