Optimizing Anti-IL17 Antibody Therapy by Associating Fiber Supplementation to Correct Treatment-aggravated Gut Dysbiosis in Axial Spondyloarthritis - RESPOND-IL17

NCT05812157 | Recruiting

• 1 other identifier: IDRCB : 2022-A00135-38
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

Fiber is the main source of energy for colonic bacteria and its consumption favorably modifies the composition of the microbiota in only a few days. Their fermentation in the colon releases short-chain fatty acids (SCFAs). Clostridiales contain many strains producing SCFAs. These SCFAs can restore the intestinal barrier and promote certain anti-inflammatory cells, including regulatory T cells (Tregs), which are essential to the mechanisms in tolerance of the self. Fibers could therefore correct the intestinal abnormalities present in patients with axial spondyloarthritis (AxSpA) and aggravated by anti-IL-17 drugs and thus improve the therapeutic response to these treatments. The hypothesis is that dietary fiber will correct the dysbiosis in AxSpA patients and increase the release of SCFAs, which favorably modulate the immune response and improve AxSpA.

Conditions

Axial Spondyloarthritis

Keywords

dysbiosis; short-chain fatty acids; fiber; microbiota

Outcome Measures

Primary Outcomes (4)

• Clostridial changes in the Experimental group

  Patients will receive fiber supplementation with inulin (Fibruline® Instant, Fagron laboratory) at a rate of 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. To confirm the efficacy of treatment, the percentage of patients with a \>10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.

  Week 0

• Clostridial changes in Controls

  Patients will receive a placebo consisting of Maltodextrin (Fagron laboratories), packaged in jars identical to those used for inulin, with a volumetric equivalent, an energy contribution and very similar color. Patients will consume 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. The percentage of patients with a \>10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.

  Week 0

• Clostridial changes in the Experimental group

  Patients will receive fiber supplementation with inulin (Fibruline® Instant, Fagron laboratory) at a rate of 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. To confirm the efficacy of treatment, the percentage of patients with a \>10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.

  Week 12

• Clostridial changes in Controls

  Patients will receive a placebo consisting of Maltodextrin (Fagron laboratories), packaged in jars identical to those used for inulin, with a volumetric equivalent, an energy contribution and very similar color. Patients will consume 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. The percentage of patients with a \>10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.

  Week 12

Secondary Outcomes (92)

• Effect of fiber supplementation on clinical therapeutic response in the experimental group: Delta BASDAI

  Week 0

• Effect of fiber supplementation on clinical therapeutic response in the experimental group: Delta BASDAI

  Week 12

• Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS20

  Week 0

• Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS20

  Week 12

• Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS40

  Week 0

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients with aSp receiving fiber supplements in the form of Fibruline® Instant (Fagron laboratories)

Dietary Supplement: Daily dietary supplementation with Fibruline; Drug: Anti-IL-17 therapy

Control group

PLACEBO COMPARATOR

Patients with aSp receiving fake fiber supplements (placebo) in the form of Maltodextrine (laboratoire Fagron).

Dietary Supplement: Daily dietary supplementation with Fibruline; Drug: Anti-IL-17 therapy

Interventions

Daily dietary supplementation with Fibruline DIETARY_SUPPLEMENT

Supplementation with 12 grams per day of Fibruline reconstituted with 60mL of water, once a day

Control group; Experimental group

Anti-IL-17 therapy DRUG

Patients in both groups will be on anti-IL-17 therapy

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with spondyloarthritis meeting the ASAS criteria
• Patient considered by the treating rheumatologist for anti-IL-17 biomedication
• Patients aged between 18 and 90 years of age
• Patients who are affiliated to a French social security system or beneficiaries of such a system
• Patients with no desire to become pregnant during the study period (Effective contraception for women of childbearing age during the study period (surgical sterilization, hormonal contraceptives, barrier method, intrauterine device))

You may not qualify if:

• Lack of written informed consent after a time of reflection
• Patient under court protection, guardianship or curatorship.
• Patient unable to give consent.
• Pregnant or breastfeeding woman
• Patients with digestive disorders for which a chronic inflammatory bowel disease has not been excluded
• Patients with fructose intolerance or glucose or galactose malabsorption
• Patients with known intolerance to inulin or maltodextrin

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (3)

Nîmes University Hospital

Nîmes, Gard, 30029, France

RECRUITING

Montpellier University Hospital

Montpellier, Hérault, 34000, France

RECRUITING

Tours Regional University Hospital (Bretonneau)

Tours, Indre-et-Loire, 37032, France

RECRUITING

MeSH Terms

Conditions

Axial Spondyloarthritis; Dysbiosis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cédric LUKAS, Professor

  Montpellier University Hospital

  STUDY DIRECTOR

• Jacques MOREL, Professor

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

• Claire DAIEN, Professor

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

• Gaël MOUTERDE, Doctor

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

• Cécile GAUJOUX-VIALA, Professor

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

• Denis MULLEMAN, Professor

  Tours University Hospital

  PRINCIPAL INVESTIGATOR

• Guillermo CARVAJAL, Doctor

  Tours University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cédric LUKAS, Professor

CONTACT

+334 67 33 87 10; c-lukas@chu-montpellier.fr

Anissa MEGZARI

CONTACT

+33466684236; drc@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All treatments will be numbered. The treatment number will be assigned according to the randomization list. All participants (patient/evaluator/etc.) will be blinded to the treatment administered. Only the hospital pharmacy will know the assigned treatment and will guarantee the blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, double-blind, prospective, randomized controlled study

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 13, 2023
• Study Start: October 2, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)