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Safety and Efficacy of Faecal Microbiota Transplantation in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases

Study Purpose

The main purposes are to explore clinical efficacy aspects, safety, and patient acceptability associated with capsule faecal microbiota transplantation (cFMT) performed in newly diagnosed, untreated patients with chronic inflammatory rheumatic-, dermatological-, gastrointestinal- and pulmonary diseases. In this double-blind, placebo-controlled, randomised, 52-week exploratory trial, 200 patients with 10 different diagnoses of CIDs (n = 20 in each diagnosis stratum) fulfilling the study criteria will be enrolled at time of diagnosis. The baseline visit will be performed as quickly as possible (days) after the patient's informed consent has been obtained to ensure no unnecessary treatment delay. Stratified by diagnosis, patients will be randomised (1:1) to either placebo or cFMT provided from an anonymous healthy donor. The experimental intervention cFMT/placebo will be repeated once weekly the following four weeks. In addition, all participants will be offered the Danish national guideline first-line immunosuppressive treatment following the baseline visit. At baseline, at 8 weeks (primary endpoint evaluation), and at 52 weeks a clinical examination will be conducted and clinical scores and patient-reported outcomes for each disease entity will be collected. All adverse events will be registered throughout the study.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Newly diagnosis of rheumatoid arthritis (RA), reactive arthritis (ReA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), psoriasis (Ps), gouty arthritis (GA), hidradenitis suppurativa (HS), pulmonary sarcoidosis (PSar), Crohn's disease (CD), or ulcerative colitis (UC).
  • - Treatment-naïve which is defined as no current or previous disease-modifying anti-rheumatic drugs or systemic immunosuppressive drugs including glucocorticoids.
  • - Presence of treatment indication (no contra-indications) and patient accept to start first-line treatment in accordance with the Danish national guideline for the specific diagnosis following the baseline visit.

Exclusion Criteria:

  • - Coeliac disease, food allergy or severe food intolerance.
  • - Current cancer.
  • - Hepatitis B and C, HIV, HTLV1/2, and active TB or other serious chronic infections.
  • - Pregnant or breastfeeding women.
  • - Not wishing to participate or not suited for FMT intervention or project evaluation.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04924270
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Torkell Ellingsen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Torkell Ellingsen, MD PhD
Principal Investigator Affiliation Odense University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOther
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis, Reactive Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Gouty Arthritis, Psoriasis, Hidradenitis Suppurativa, Pulmonary Sarcoidosis, Crohn Disease, Ulcerative Colitis
Arms & Interventions

Arms

Experimental: cFMT

Placebo Comparator: Placebo

Interventions

Biological: - Faecal microbiota transplantation

The capsule FMT transplant consists of faeces obtained from a thoroughly screened, unpaid, anonymous stool donor. Each FMT product is made from 50g faeces diluted in sterile saline (0.9% NaCl) and glycerol, blended, centrifuged and filtered to remove particulate material before transfer to double-layered capsules. The FMT capsules will be stored at - 80 ⁰C until use. On the day of the FMT, the FMT capsules will be thawed to room temperature before treatment.

Other: - Placebo

Placebo capsules consist of NaCl (0.9%) and glycerol added brown food colouring.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Torkell Ellingsen, MD PhD

torkell.ellingsen@rsyd.dk

0045 6611 3333

For additional contact information, you can also visit the trial on clinicaltrials.gov.