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Psoriatic ArthritisFLORANCT03058900

Efficacy and Safety of Fecal Microbiota Transplantation in Peripheral Psoriatic Arthritis

A study testing Fecal microbiota transplantation (FMT) and Methotrexate (MTX) in people with Psoriatic Arthritis, run by Odense University Hospital at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

An abnormal intestinal microbiota may be the mediator of the common inflammatory pathways seen in psoriatic arthritis. This study will explore clinical aspects associated with modifying the intestinal microbiota by infusing fecal donor microbiota into the small intestine of psoriatic arthritis patients with a minimum… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Psoriatic Arthritis
What is being tested?
Fecal microbiota transplantation (FMT) and Methotrexate (MTX)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
2 sitesDenmark
Study dates
16 May 2017to 2 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
  • Presence of active peripheral psoriatic arthritis defined as ≥ 3 swollen joints.
  • Methotrexate (≥ 15mg/week (maximal tolerable dosage)) for a minimum of 3 months prior to study inclusion.

Who cannot join

  • Other inflammatory rheumatic diseases than PsA.
  • Current axial disease activity or severe peripheral joint activity demanding immediate change of treatment or contraindicating placebo treatment for 6 months.
  • History of severe MTX toxicity or allergic reactions.
  • Current biological treatment and biological treatment within the last 6 months.
  • Inflammatory bowel disease, celiac disease, food allergy, or other intestinal diseases.
  • Current cancer or severe chronic infections.
Show all 11Show fewer
  • Pregnant or breastfeeding women.
  • Systemic and/or local intra-articular or peritendinous steroid injections within 3 months of inclusion.
  • Non-MTX DMARD treatment within three months of inclusion.
  • Antibiotics within 3 months of inclusion.
  • Not wishing to participate or unsuited for project evaluation.

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Dept. of Rheumatology at Odense University Hospital

    Odense, 5000

  • Diagnostic Centre at Silkeborg Regional Hospital

    Silkeborg, 8600

Other trials in Denmark

About this study

Official title: Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Peripheral Psoriatic Arthritis: a 6-month, Double-Blind, Randomized, Placebo-Controlled Trial

An abnormal intestinal microbiota may be the mediator of the common inflammatory pathways seen in psoriatic arthritis. This study will explore clinical aspects associated with modifying the intestinal microbiota by infusing fecal donor microbiota into the small intestine of psoriatic arthritis patients with a minimum of three swollen joints despite at least three months of methotrexate treatment.

Read the detailed description

Recent years have seen growing recognition of the complexity of the role of the microbiota in shaping the immune system and its potential effects for health and disease. In particular, the gut bacteria composition has been associated with the pathogenesis of autoimmune and inflammatory diseases. Intriguingly, presence of intestinal inflammation in psoriatic arthritis (PsA) patients has been documented in several studies. Also, in genetically predisposed patients reactive arthritis, which share some of the clinical manifestations of PsA, can be triggered by certain types of bacterial gut infections. Furthermore, a recent study has reported that several intestinal bacteria including Akkermansia and Ruminoccocus, which are known to play an important role in maintaining gut homeostasis, were practically absent in PsA patients. Mechanisms through which the microbiota may be involved in the pathogenesis of PsA include an abnormal activation of the gut-associated lymphoid tissue (GALT) and/or an altered mucosal permeability thus compromising the capacity of the intestine to provide adequate containment of luminal microorganisms and molecules.

By conducting a double-blinded, randomized, placebo-controlled trial of a non-related donor fecal microbiota transplantation (FMT) infused into the small intestine, this study will reveal whether FMT is more effective than an identically appearing placebo (saline) in reducing disease activity in psoriatic arthritis patients presenting with a minimum of three swollen joints despite at least three months of methotrexate treatment (maximal tolerable dosis ≥ 15 mg/week). All patients will throughout the study continue their individual treatment with weekly methotrexate.

Being tested
Fecal microbiota transplantation (FMT), Drug: Placebo (saline), Methotrexate (MTX)
Keywords
Fecal Microbiota Transplantation, FMT, Randomized Controlled Trial, Intestinal microbiome, RCT, Faecal microbiota transplantation
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fecal microbiota transplantation (FMT)Drug

    One fecal microbiota transplantation is performed at baseline using gastroscopic guidance. The transplant consists of 50 g feces obtained from a healthy non-related donor. The donor feces is suspended into NaCl (0.9%) and glycerol (10%), and will be stored at minus 80 degrees celsius until use. The total volume of the suspension is 250 mL and its temperature will be 37 degrees celsius when infused into the small intestine of the recipient.

  • Drug: Placebo (saline)Other

    One identical appearing sham procedure is performed at baseline using gastroscopic guidance. 250 mL saline (NaCl 0.9%) is infused into the small intestine of the recipient.

  • Methotrexate (MTX)Drug

    Weekly methotrexate in maximum tolerable dosis

Study groups in NCT03058900
Study groupRoleWhat they receive
Fecal microbiota transplantation (FMT)ExperimentalNot described
Receives: Drug: Fecal microbiota transplantation (FMT); Drug: Methotrexate (MTX)
Placebo (saline)Sham comparatorNot described
Receives: Other: Drug: Placebo (saline); Drug: Methotrexate (MTX)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment failure

    Proportion of patients in each group who experience treatment failure according to shared decision making between patient and rheumatologist defined as at least one of the following:

    • Need for more than 1 intra-articular glucocorticoid injection due to disease activity.
    • Need for change to other conventional DMARDs (at the moment oral leflunomide, sulfasalazin or ciclosporin) according to the updated Danish guideline treatment due to disease activity.
    • Need for biologic treatment according to the updated Danish guideline treatment due to severe disease activity.

    Measured: 6 months (+/- 14 days)

Secondary outcomes (11)

  1. The Short Health Assessment Questionnaire (2-page HAQ)

    Change from baseline in the Short Health Assessment Questionnaire (2-page HAQ).

    Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months (+/- 7 days), 6 months (+/- 14 days)

  2. The Dermatology Life Quality Index (DLQI) Questionnaire

    Change from baseline in the Dermatology Life Quality Index (DLQI).

    Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months (+/- 7 days), 6 months (+/- 14 days)

  3. Patient Reported Gastrointestinal Side Effects

    Change from baseline in gastrointestinal symptoms.

    Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months (+/- 7 days), 6 months (+/- 14 days)

  4. Patient Reported Other Side Effects

    Change from baseline in other (non-gastrointestinal) symptoms.

    Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months (+/- 7 days), 6 months (+/- 14 days)

  5. The American College of Rheumatology (ACR) Response Criteria

    Proportion of patients in each group achieving

    • ACR20 response criteria
    • ACR50 response criteria
    • ACR70 response criteria

    A patient will be considered as improved according to the ACR20/50/70 response criteria if she/he has at least 20/50/70% improvement in the two following measures: Tender joint count (68) and swollen joint count (66), and at least 3 of the following 5 measures: Patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ) score, acute phase reactant (CRP).

    Measured: Baseline, 3 months (+/- 7 days), 6 months (+/- 14 days)

  6. The Psoriatic Arthritis Response Criteria (PsARC)

    Proportion of patients in each group achieving PsARC response criteria. A patient will be considered as improved according to the PsARC response criteria if she/he has an improvement in either joint swelling or tenderness, and in any of 4 other measures: Patient global assessment of articular disease; physician global assessment of articular disease; joint pain or tenderness; joint swelling.

    Measured: Baseline, 3 months (+/- 7 days), 6 months (+/- 14 days)

  7. The Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index

    Change from baseline in SPARCC Enthesitis Index in the subset of patients who have enthesitis at baseline.

    Measured: Baseline, 3 months (+/- 7 days), 6 months (+/- 14 days)

  8. The Psoriasis Area Severity Index (PASI)

    Change from baseline in the Psoriasis Area Severity Index (PASI) in the subset of patients who have psoriasis at baseline.

    Measured: Baseline, 3 months (+/- 7 days), 6 months (+/- 14 days)

  9. Dactylitis

    Change from baseline in the number of digits affected with dactylitis in the subset of patients who have dactylitis at baseline.

    Measured: Baseline, 3 months (+/- 7 days), 6 months (+/- 14 days)

  10. Number of Adverse Events

    Number of adverse events in each group.

    Measured: 6 months (+/- 14 days)

  11. Number of Patients with Adverse Events

    Number of patients with at least one adverse event in each group.

    Measured: 6 months (+/- 14 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2017
  2. Study start16 May 2017
  3. Primary completion2 Jun 2020
  4. Study completion2 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03058900
Sponsor's protocol ID
OUH-DC-FLORA-01
Acronym
FLORA
Status last verified
Dec 2020
First submitted
13 Feb 2017
Last updated
7 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Coates LC, Conaghan PG, Emery P, Green MJ, Ibrahim G, MacIver H, Helliwell PS. Sensitivity and specificity of the classification of psoriatic arthritis criteria in early psoriatic arthritis. Arthritis Rheum. 2012 Oct;64(10):3150-5. doi: 10.1002/art.34536.

    PubMed 22576997

  • Taylor W, Gladman D, Helliwell P, Marchesoni A, Mease P, Mielants H; CASPAR Study Group. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum. 2006 Aug;54(8):2665-73. doi: 10.1002/art.21972.

    PubMed 16871531

  • Kingsley GH, Kowalczyk A, Taylor H, Ibrahim F, Packham JC, McHugh NJ, Mulherin DM, Kitas GD, Chakravarty K, Tom BD, O'Keeffe AG, Maddison PJ, Scott DL. A randomized placebo-controlled trial of methotrexate in psoriatic arthritis. Rheumatology (Oxford). 2012 Aug;51(8):1368-77. doi: 10.1093/rheumatology/kes001. Epub 2012 Feb 17.

    PubMed 22344575

  • Statnikov A, Alekseyenko AV, Li Z, Henaff M, Perez-Perez GI, Blaser MJ, Aliferis CF. Microbiomic signatures of psoriasis: feasibility and methodology comparison. Sci Rep. 2013;3:2620. doi: 10.1038/srep02620.

    PubMed 24018484

  • Eppinga H, Konstantinov SR, Peppelenbosch MP, Thio HB. The microbiome and psoriatic arthritis. Curr Rheumatol Rep. 2014 Mar;16(3):407. doi: 10.1007/s11926-013-0407-2.

    PubMed 24474190

  • Jacques P, Elewaut D. Joint expedition: linking gut inflammation to arthritis. Mucosal Immunol. 2008 Sep;1(5):364-71. doi: 10.1038/mi.2008.24. Epub 2008 Jul 9.

    PubMed 19079200

  • Scher JU, Sczesnak A, Longman RS, Segata N, Ubeda C, Bielski C, Rostron T, Cerundolo V, Pamer EG, Abramson SB, Huttenhower C, Littman DR. Expansion of intestinal Prevotella copri correlates with enhanced susceptibility to arthritis. Elife. 2013 Nov 5;2:e01202. doi: 10.7554/eLife.01202.

    PubMed 24192039

  • Brusca SB, Abramson SB, Scher JU. Microbiome and mucosal inflammation as extra-articular triggers for rheumatoid arthritis and autoimmunity. Curr Opin Rheumatol. 2014 Jan;26(1):101-7. doi: 10.1097/BOR.0000000000000008.

    PubMed 24247114

  • Scher JU, Ubeda C, Artacho A, Attur M, Isaac S, Reddy SM, Marmon S, Neimann A, Brusca S, Patel T, Manasson J, Pamer EG, Littman DR, Abramson SB. Decreased bacterial diversity characterizes the altered gut microbiota in patients with psoriatic arthritis, resembling dysbiosis in inflammatory bowel disease. Arthritis Rheumatol. 2015 Jan;67(1):128-39. doi: 10.1002/art.38892.

    PubMed 25319745

  • Zhang X, Zhang D, Jia H, Feng Q, Wang D, Liang D, Wu X, Li J, Tang L, Li Y, Lan Z, Chen B, Li Y, Zhong H, Xie H, Jie Z, Chen W, Tang S, Xu X, Wang X, Cai X, Liu S, Xia Y, Li J, Qiao X, Al-Aama JY, Chen H, Wang L, Wu QJ, Zhang F, Zheng W, Li Y, Zhang M, Luo G, Xue W, Xiao L, Li J, Chen W, Xu X, Yin Y, Yang H, Wang J, Kristiansen K, Liu L, Li T, Huang Q, Li Y, Wang J. The oral and gut microbiomes are perturbed in rheumatoid arthritis and partly normalized after treatment. Nat Med. 2015 Aug;21(8):895-905. doi: 10.1038/nm.3914. Epub 2015 Jul 27.

    PubMed 26214836

  • Yeoh N, Burton JP, Suppiah P, Reid G, Stebbings S. The role of the microbiome in rheumatic diseases. Curr Rheumatol Rep. 2013 Mar;15(3):314. doi: 10.1007/s11926-012-0314-y.

    PubMed 23378145

  • Scarpa R, Manguso F, D'Arienzo A, D'Armiento FP, Astarita C, Mazzacca G, Ayala F. Microscopic inflammatory changes in colon of patients with both active psoriasis and psoriatic arthritis without bowel symptoms. J Rheumatol. 2000 May;27(5):1241-6.

    PubMed 10813294

  • Van Praet L, Van den Bosch F, Mielants H, Elewaut D. Mucosal inflammation in spondylarthritides: past, present, and future. Curr Rheumatol Rep. 2011 Oct;13(5):409-15. doi: 10.1007/s11926-011-0198-2.

    PubMed 21744132

  • Lindqvist U, Kristjansson G, Pihl-Lundin I, Hagforsen E, Michaelsson G. Patients with psoriatic arthritis have an increased number of lymphocytes in the duodenal mucosa in comparison with patients with psoriasis vulgaris. J Rheumatol. 2006 May;33(5):924-7. Epub 2006 Mar 15.

    PubMed 16541478

  • Morgan XC, Huttenhower C. Meta'omic analytic techniques for studying the intestinal microbiome. Gastroenterology. 2014 May;146(6):1437-1448.e1. doi: 10.1053/j.gastro.2014.01.049. Epub 2014 Jan 28.

    PubMed 24486053

Questions about this trial

What is this clinical trial studying?

A study testing Fecal microbiota transplantation (FMT) and Methotrexate (MTX) in people with Psoriatic Arthritis, run by Odense University Hospital at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment failure (time frame: 6 months (+/- 14 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03058900, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.

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