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Effects of a Probiotic Supplementation on Symptoms and Microbiome Characteristics in Patients With Non-celiac Gluten/Wheat Sensitivity.

NCT06884241 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-03-19

No results posted yet for this study

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 study included adults diagnosed with NCWS. Participants received a 6-week intervention with either probiotics or a placebo. For the first 4 weeks, all participants followed a gluten-free, low-FODMAP diet, after which gluten was reintroduced.

Gastrointestinal symptoms (using the modified Gastrointestinal Symptom Rating Scale (GSRS)) and fecal samples were collected at baseline (T0), after 4 weeks (T1), and after 6 weeks (T2). Gut microbiome composition was assessed through whole-shotgun metagenomic sequencing and fecal volatile organic compounds (VOCs) were analyzed using gas chromatography-mass spectrometry (GC-MS).

Conditions

  • Gluten Sensitivity
  • Wheat Sensitivity

Interventions

DIETARY_SUPPLEMENT

Probiotic supplementation

The intervention consists of a 6-week supplementation with a specific combination of probiotics: Lactiplantibacillus plantarum P17630 49x109, Lacticaseibacillus paracasei I1688 1x109, Ligilactobacillus salivarius I1794 25x106. All participants were given a gluten-free, low FODMAPs diet. After 4 weeks (T1), foods containing gluten were reintroduced in the diet of all participants (at least 6 g/day of gluten), while the reduced FODMAP content was maintained

OTHER

Placebo

The participants received placebo for 6 weeks. Placebo was identical in appearance, texture, taste, and packaging to the probiotic treatment. All participants were given a gluten-free, low FODMAPs diet. After 4 weeks (T1), foods containing gluten were reintroduced in the diet of all participants (at least 6 g/day of gluten), while the reduced FODMAP content was maintained

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Simona Bo, Associate Professor, MD · University of Torino

  • Ilario Ferrocino, Professor · University of Turin, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-10
Primary Completion
2024-12-03
Completion
2025-01-10

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06884241 on ClinicalTrials.gov