Efficacy of Modification of Lifestyle in the Treatment of Ankylosing Spondylitis: a Pilot Study (EMLAS)

Efficacy of Modification of Lifestyle in the Treatment of Ankylosing Spondylitis

Axial spondyloarthritis (axSpA) is a chronic inflammatory immune disorder with a global prevalence that ranges from 20 to 160 cases per 10000 individuals. axSpA has two forms of clinical presentation (radiographic and non-radiographic) based on the presence or absence of radiographic sacroiliitis. This condition mostly affects the vertebral spine, and is characterized by joint pain and stiffness, fatigue, and restricted function, which leads to a substantial physical, psychological, and socioeconomic burden. The clinical management of axSpA needs to combine pharmacological and non-pharmacological approaches to reduce inflammation and improve health-related quality of life.

The aim of the study will be to determine if a 12-week probiotic supplementation will be more effective than an online-delivered strength training program at improving functional capacity in adults with non-radiographic axSpA. As a secondary aim, we will compare the impact of both interventions on disease activity, spinal mobility, quality of life and biochemical measures. This will be the first randomized controlled trial where probiotics are compared with an active intervention.

Study Overview

• Status: Completed
• Conditions: Autoimmune Diseases; Arthritis; Rheumatic Diseases
• Intervention / Treatment: Dietary supplement: Probiotic group; Other: Exercise group

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Arroyomolinos, Madrid, Spain, 28939
      • Elena Sonsoles Rodriguez Lopez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must be aged 18 years or older and have a confirmed diagnosis of non-radiographic axSpA following the 2009 Assessment of the SpondyloArthritis International Society classification criteria

Exclusion Criteria:

• Any systemic disease or comorbidity that may severely impair exercise capacity.
• A high sensitivity C-reactive protein 10-fold greater than the normal upper limit (2.87 mg/l).
• Any changes to medical treatment within the previous 2 months, and having an active peripheral arthritis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic group; Participants in the probiotics group will receive probiotic supplementation for 12 weeks.	Dietary supplement: Probiotic group; During the first 4 weeks, patients will be instructed to take two capsules of Enterelle plus (Bromatech lab, Manno, Switzerland) during morning time, before or after breakfast. Enterelle plus contains specific strains, i.e., S boulardi, E faecium, and acidophilus, that contribute to reduce the mycotic flora and modulate the gastrointestinal transit. For the next 8 weeks, participants will be told to ingest two capsules of Adomelle (Bromatech lab, Manno, Switzerland) at night, during or right after dinner. Adomelle contains several strains, including Bifidobacterium breve, that help to reduce abdominal fat, pain, and gas, and control the frequency of deposition
Active Comparator: Exercise group; The control group will undergo a 12-week online-delivered Tabata program, as a form of high-intensity interval training.	Other: Exercise group; This type of intervention has shown to benefit patients with several chronic conditions 23, including axSpA 13. Exercises combined high knees, lunges, basic burpees, plank, skipping, mountain climbers, and squats with jumps. The training routine will be conducted three times per week, and each session will last around 8 minutes (2 sets of 4 minutes, with a 10 second rest between them). All sessions will be individually tailored and supervised by a senior professional with a degree in Physiotherapy and Sciences of Physical Activity and Sport. Overall, participants will be told to continue exercising if low to moderate bearable pain appeared during training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome will be functional disability during daily life activities, evaluated with the Bath Ankylosing Spondylitis Functional Index.	The Bath Ankylosing Spondylitis Functional Index includes 10 items (scale of 0 to 10, higher scores denoting worse performance), and is among the recommended core set of instruments for axSpA.	Change from Baseline BASFI at 4 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary outcome will be disease activity during daily life activities, evaluated with the Bath Ankylosing Spondylitis Disease Activity Index.	Disease activity will be assessed with the Bath Ankylosing Spondylitis Disease Activity Index. The Bath Ankylosing Spondylitis Disease Activity Index explores five different constructs (fatigue, spinal or peripheral joint pain, localized tenderness, and morning stiffness), with lower scores representing less disease activity (scale of 0 to 10).	Change from Baseline BASDAI at 4 and 12 weeks
Spinal mobility will be measured with the Bath Ankylosing Spondylitis Metrology Index (BASMI)	Bath Ankylosing Spondylitis Metrology Index as a composite index including lumbar flexion and side flexion (cm), tragus-to-wall and intermalleolar distance (cm), and cervical rotation (degrees). Final scores of the BASMI range from 0 "no mobility limitation" to 10 "severe limitation".	Change from Baseline BASMI at 4 and 12 weeks
The Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) 30 will be used to determine health-related quality of life	The ASQoL is valid, feasible and reliable. Total score range between 0 and 18, with higher scores indicating poorer quality of life.	Change from Baseline ASQoL at 4 and 12 weeks
Biochemical measures (interleukin-1 (IL-1) and tumor necrosis factor a (TNFa))	A PeliKine compact enzyme-linked immunosorbent assay (ELISA) kit will be used to explore two inflammatory biomarkers	Change from Baseline biochemical measures at 4 and 12 weeks

Collaborators and Investigators

• Sponsor: Camilo Jose Cela University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Actual): June 10, 2023
• Study Completion (Actual): June 10, 2023

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Immune System Diseases; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Bone Diseases, Infectious; Ankylosis; Axial Spondyloarthritis; Rheumatic Diseases; Collagen Diseases; Autoimmune Diseases; Spondylitis; Spondylitis, Ankylosing
• Other Study ID Numbers: EMLAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No