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

NCT06884241 | Completed

• 1 other identifier: GLUTEN_2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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

Keywords

gluten sensitivity; wheat sensitivity; probiotics; microbiome

Outcome Measures

Primary Outcomes (1)

• Change in Symptoms Following Gluten Reintroduction

  The primary outcome was evaluating between-group differences in symptoms reported by participants after gluten reintroduction, as measured by the modified Gastrointestinal Symptom Rating Scale (GSRS), according to the Salerno Experts criteria. Participants were defined as "tolerant" to the gluten-containing diet if their total GSRS scores did not change or reduced 2 weeks after the gluten introduction (T2)

  Symptoms were assessed at baseline (T0), after 4 weeks of a gluten-free diet (T1), and after 2 weeks of gluten reintroduction (T2).

Secondary Outcomes (2)

• Gut microbiome composition after probiotic supplementation

  Gut microbiome was analyzed at baseline (T0), after 4 weeks of a gluten-free diet (T1), and after 2 weeks of gluten reintroduction (T2).

• Fecal volatilome after probiotic supplementation

  Volatilome was analyzed at baseline and after 4 weeks of a gluten-free diet (T1), and after 2 weeks of gluten reintroduction (T2).

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Dietary Supplement: Probiotic supplementation

Control arm

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Probiotic supplementation DIETARY_SUPPLEMENT

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

Intervention arm

Placebo OTHER

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

Control arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

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

Torino, 10126, Italy

Location

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Simona Bo, Associate Professor, MD

  University of Torino

  PRINCIPAL INVESTIGATOR

• Ilario Ferrocino, Professor

  University of Turin, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 19, 2025
• Study Start: September 10, 2018
• Primary Completion: December 3, 2024
• Study Completion: January 10, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)