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

NCT04274374 | Recruiting

• 2 other identifiers: PHRC IR 2017 COUDERC2018-A00309-46
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Ankylosing Spondyloarthritis

Keywords

spondyloarthritis; ankylosing spondylitis; gluten-free diet; gut microbiota

Outcome Measures

Primary Outcomes (1)

• Assessment of the variation in quality of life evaluated variation inby the Assessment of SpondyloArthritis international Society (ASAS) Health Index

  The self-report questionnaire measures functioning and health across 17 aspects of health and 9 environmental factors (EF) in patients with SpA. The total sum of the ASAS HI ranges from 0-17, with a lower score indicating a better health status.

  Change from baseline ASAS HI score at 16 weeks

Secondary Outcomes (11)

• effects of a 16-week GFD versus placebo diet on the activity of SpA evaluated by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).

  Change from baseline BASDAI score at 16 weeks

• effects of a 16-week GFD versus placebo diet on parameters of inflammation evaluated by the erythrocyte sedimentation rate (ESR).

  Change from baseline ESR at 16 weeks

• effects of a 16-week GFD versus placebo diet on parameters of inflammation evaluated by the C-reactive protein (CRP)

  Change from baseline CRP at 16 weeks

• effects of a 16-week GFD versus placebo diet on fatigue assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.

  Change from baseline FACIT score at 16 weeks

• effects of a 16-week GFD versus placebo diet on depression evaluated by the Hospital anxiety and depression scale (HAD)

  Change from baseline HAD score at 16 weeks

Study Arms (2)

experimental arm

EXPERIMENTAL

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

Dietary Supplement: Gluten-Free Diet

control arm

ACTIVE COMPARATOR

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

Dietary Supplement: Gluten Diet

Interventions

Gluten-Free Diet DIETARY_SUPPLEMENT

Dietary supplement without gluten

experimental arm

Gluten Diet DIETARY_SUPPLEMENT

Dietary supplement with gluten

control arm

Eligibility Criteria

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

You may qualify if:

• diagnosis of axial SpA defined by ASAS criteria
• able to follow a GFD and to provide written informed consent and submit to the requirements of the study

You may not qualify if:

• have a history of celiac disease;
• are pregnant, breastfeeding,
• not covered by social security;
• minors or adults under the protection of the law or under the protection of justice.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• PANZANI: collaborator
• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: collaborator

Study Sites (7)

CHU de Bordeaux

Bordeaux, 33000, France

NOT YET RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

CHU de Grenoble

Grenoble, 38000, France

NOT YET RECRUITING

Hospices Civils de Lyon

Lyon, 69000, France

NOT YET RECRUITING

CHU de Montpellier

Montpellier, 34000, France

NOT YET RECRUITING

Assistance Publique - Hôpitaux de Paris (AP-HP) - Hôpital Cochin

Paris, 75000, France

NOT YET RECRUITING

CHU de Saint-Etienne

Saint-Etienne, 42000, France

NOT YET RECRUITING

Related Publications (1)

• Couderc M, Pereira B, Schaeverbeke T, Thomas T, Chapurlat R, Gaudin P, Morel J, Dougados M, Soubrier M. GlutenSpA trial: protocol for a randomised double-blind placebo-controlled trial of the impact of a gluten-free diet on quality of life in patients with axial spondyloarthritis. BMJ Open. 2020 Nov 20;10(11):e038715. doi: 10.1136/bmjopen-2020-038715.

  PMID: 33444189 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing; Spondylarthritis

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Marion Couderc, MD

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre, Pharm D

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 18, 2020
• Study Start: October 7, 2021
• Primary Completion: October 1, 2025
• Study Completion: March 1, 2026
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)