Status:
COMPLETED
Effects of a Probiotic Supplementation on Symptoms and Microbiome Characteristics in Patients With Non-celiac Gluten/Wheat Sensitivity.
Lead Sponsor:
University of Turin, Italy
Conditions:
Gluten Sensitivity
Wheat Sensitivity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The aim of this randomized, double-blind, placebo-controlled clinical trial is to investigate the effects of probiotics on symptoms and gut microbiota composition following gluten reintroduction. The...
Detailed Description
Non-Celiac Gluten Sensitivity (NCGS), or Non-Celiac Wheat Sensitivity (NCWS), is a condition characterized by the onset of gastrointestinal and systemic symptoms following the consumption of gluten-co...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- age≥18 years
- NCGWS demonstrated by the following self-reported conditions i) intestinal and extra intestinal symptoms associated within hours or days after the ingestion of gluten-containing food, ii) a clear benefit while on a gluten-free diet, iii) relapse of symptoms with the ingestion of gluten-containing foods, iv) a positive response to the double-blind placebo-controlled (DBPC) cross-over gluten challenge test, as previously described.
- Exclusion criteria:
- presence of Crohn disease (CD), wheat allergy (WA), irritable bowel syndrome (IBS), and other gastrointestinal diseases, H. Pylori infection, lactose intolerance, history of gastrointestinal surgery, liver/pancreatic diseases, active or recent infection diseases, known psychiatric diseases, any systemic diseases
- pregnancy or breastfeeding
- active use of antibiotics, pre-probiotics, immunosuppressive drugs, non-steroidal anti-inflammatory drugs, or corticosteroids,
- inability to give written informed consent.
Exclusion
Key Trial Info
Start Date :
September 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06884241
Start Date
September 10 2018
End Date
January 10 2025
Last Update
March 19 2025
Active Locations (1)
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1
AOU Città della Salute e della Scienza di Torino, University of Torino
Torino, Italy, 10126