Tolerability of an Ancient Grain in Patients With Non-Celiac Wheat Sensitivity

NARecruitingINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

February 1, 2024

Primary Completion Date

July 31, 2025

Study Completion Date

November 30, 2026

Conditions
Non-celiac Gluten Sensitivity
Interventions
DIETARY_SUPPLEMENT

Administration of Triticum Monococcum flour

"Patients will be administered a daily dose of 80g of flour of Triticum Monococcum (equivalent to 10g of gluten), which will be dissolved and cooked by the patients themselves. During the challenge, the severity of the symptoms will be recorded using a 10-points visual analog scale (VAS). The challenges will be stopped when clinical reactions will occur for at least 2 consecutive days (increase \>3 in VAS) for either GI or extraintestinal symptoms.~Challenges will be considered positive if symptoms, which had been initially present, reappear after their disappearance on elimination diet, and if the GI and/or extraintestinal symptom's scores will be \>30% compared to any eventual increase determined during the administration of the other wheat variety."

DIETARY_SUPPLEMENT

Administration of Triticum Aestivum flour

"Patients will be administered a daily dose of 80g of flour of Triticum Aestivum (equivalent to 10g of gluten), which will be dissolved and cooked by the patients themselves. During the challenge, the severity of the symptoms will be recorded using a 10-points visual analog scale (VAS). The challenges will be stopped when clinical reactions will occur for at least 2 consecutive days (increase \>3 in VAS) for either GI or extraintestinal symptoms.~Challenges will be considered positive if symptoms, which had been initially present, reappear after their disappearance on elimination diet, and if the GI and/or extraintestinal symptom's scores will be \>30% compared to any eventual increase determined during the administration of the other wheat variety."

Trial Locations (1)

90127

RECRUITING

University Hospital of Palermo, Palermo

All Listed Sponsors
lead

University of Palermo

OTHER