Effects of a Probiotic Supplementation on Symptoms and Microbiome Characteristics in Patients With Non-celiac Gluten/Wheat Sensitivity.
Launched by UNIVERSITY OF TURIN, ITALY · Mar 12, 2025
Trial Information
Current as of April 29, 2025
Completed
Keywords
ClinConnect Summary
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-containing foods, without the presence of celiac disease or wheat allergy.
The aim of the present randomized, double-blind controlled trial is to explore probiotics as a potential therapeutic option to alleviate symptoms and improve gut microbiome composition.
Participants Eligible participants were adults aged 18 or older with NCGWS, confirmed by a positive response to the double-blind placebo...
Gender
ALL
Eligibility criteria
- 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.
About University Of Turin, Italy
The University of Turin, located in Italy, is a prestigious academic institution renowned for its commitment to research and innovation in the medical field. As a clinical trial sponsor, the university leverages its extensive expertise and resources to advance scientific knowledge and improve patient outcomes. Collaborating with a network of healthcare professionals and researchers, the University of Turin conducts rigorous clinical trials that adhere to the highest ethical and regulatory standards. Its focus on translational research ensures that findings contribute to the development of effective therapies and healthcare solutions, enhancing the overall well-being of diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Torino, , Italy
Patients applied
Trial Officials
Simona Bo, Associate Professor, MD
Principal Investigator
University of Torino
Ilario Ferrocino, Professor
Study Director
University of Turin, Italy
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported