Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 70 Years|
- - 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.
- - 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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
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|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
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|
Placebo Comparator: Placebo
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.
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
For additional contact information, you can also visit the trial on clinicaltrials.gov.