Impact of a Gluten-free Diet on Quality of Life in Patients With Axial Spondyloarthritis.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-07

Study Completion Date

2026-03-31

Brief Summary

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Subclinical intestinal inflammation and gut dysbiosis have been reported in patients with spondyloarthritis (SpA). In common practice, rheumatologists are increasingly confronted with patients with inflammatory rheumatism who are on gluten-free diets (GFDs), despite the lack of reliable data from controlled studies. This study aims to determine the impact of a GFD on the quality of life of patients with axial SpA.

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Detailed Description

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The GlutenSpA study is a 24-week, randomized, double-blinded, placebo-controlled, multicenter trial. Patients with axial SpA (n=200) will follow a 16-week GFD and be randomly assigned (1:1) to an experimental or control arm. In the experimental arm with receive at least 6 gluten-free breads per day + 200 g of gluten-free penne pasta per week + 6 rice flavor capsules per day. The control arm will receive at least 6 gluten-containing breads per day + 200 g of gluten-containing penne pasta per week + 6 vital gluten-containing capsules per day.

At baseline, the dietician will explain to the patients how to properly follow a GFD during a face-to-face interview. The patient's compliance to the GFD will be evaluated by the dietician at S2, S16, an S24 using an online 3-day alimentary questionnaire.

The bread and penne pasta were chosen for their visual resemblance and similar taste to maximize the blindness of the study. In order to reach the daily amount of gluten in a standard diet (estimated in France between 10 and 15 g/d) in the control arm, each day patients will have to ingest six capsules of vital gluten wheat made for the study. Vital gluten flour is an over-the-counter food supplement used to enrich a protein diet or as a base for making products, such as seitan. Capsules will be made using commercially available vital gluten and contain 0.35 g of gluten per capsule. The total amount of gluten in the control arm will be approximately 10.5 g/day.

After the 16-week GFD, patients will be offered to follow or not follow the GFD according to their own decision for an 8-week open-labelled follow-up period. The study duration for each patient is 24 weeks. The patient recruitment is expected to last 2 years

Conditions

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Ankylosing Spondyloarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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experimental arm

In the experimental arm will receive at least 6 gluten-free breads per day + 200 g of gluten-free penne pasta per week + 6 rice flavor capsules per day

Group Type EXPERIMENTAL

Gluten-Free Diet

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement without gluten

control arm

the control arm will received 6 gluten-containing breads per day + 200 g of gluten-containing penne pasta per week + 6 vital gluten-containing capsules per day

Group Type ACTIVE_COMPARATOR

Gluten Diet

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement with gluten

Interventions

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Gluten-Free Diet

Dietary supplement without gluten

Intervention Type DIETARY_SUPPLEMENT

Gluten Diet

Dietary supplement with gluten

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* diagnosis of axial SpA defined by ASAS criteria
* Rheumatologist not wish to change the treatment within 4 months of inclusion,
* stable treatment (NSAID and/or DMARD) for at least 3 months but no corticosteroid infiltration in the month prior to inclusion,
* able to follow a GFD and to provide written informed consent and submit to the requirements of the study

Exclusion Criteria

* Any diet at the time of inclusion or within 3 months prior to inclusion;
* have a history of celiac disease;
* received antibiotic treatment within 3 months of inclusion or are taking a probiotic;
* are pregnant, breastfeeding,
* not covered by social security;
* minors or adults under the protection of the law or under the protection of justice.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marion Couderc, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Clermont-Ferrand

Locations

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