Completed

Probiotic Supplementation for Non-Celiac Gluten/Wheat Sensitivity Symptoms and Microbiome

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What is being tested

Probiotic supplementation

+ Placebo

Dietary SupplementOther
Who is being recruted

Celiac Disease+4

+ Digestive System Diseases

+ Gastrointestinal Diseases

From 18 to 65 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: September 2018
See protocol details

Summary

Principal SponsorUniversity of Turin, Italy
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 10, 2018

Actual date on which the first participant was enrolled.

This clinical trial investigates whether taking probiotics can help people with Non-Celiac Gluten/Wheat Sensitivity (NCGWS) feel better and improve their gut health. NCGWS causes uncomfortable symptoms when eating gluten, even though it isn't celiac disease or a wheat allergy. The study is important because it looks for new ways to ease symptoms and improve the quality of life for those affected. Adults 18 and older with confirmed NCGWS are part of the study, while those with other conditions or who are pregnant or breastfeeding are not included. Participants in the study receive either probiotic sachets or placebo sachets for six weeks. They follow a gluten-free and low FODMAPs diet, and after four weeks, gluten is added back into their diets. The researchers and participants do not know who receives the probiotics or the placebo to ensure unbiased results. The study measures changes using a questionnaire and by analyzing stool samples at different stages to see how probiotics affect symptoms and gut bacteria. This helps determine whether probiotics could be a beneficial treatment option for NCGWS.

Official TitleEffects of a Probiotic Supplementation on Symptoms and Microbiome Characteristics in Patients With Non-celiac Gluten/Wheat Sensitivity. A Randomized Controlled Double-blind Trial.
NCT06884241
Principal SponsorUniversity of Turin, Italy
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Celiac DiseaseDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesMalabsorption SyndromesMetabolic DiseasesNutritional and Metabolic Diseases

Criteria

2 inclusion criteria required to participate
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.
age≥18 years
4 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants in this arm received a supplementation of probiotics for 6 weeks.

Group II

Placebo
Participants in this arm received placebo for 6 weeks. The placebo were identical in size, shape, color, and taste to the probiotic.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

AOU Città della Salute e della Scienza di Torino, University of Torino

Torino, ItalyOpen AOU Città della Salute e della Scienza di Torino, University of Torino in Google Maps
CompletedOne Study Center