Exploratory Clinical Study on Fasting in Psoriasis and Psoriatic Arthritis (RiseFast) (NCT06905028) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Exploratory Clinical Study on Fasting in Psoriasis and Psoriatic Arthritis (RiseFast)
Germany30 participantsStarted 2025-04-04
Plain-language summary
The RiseFast pilot study will investigate the clinical, metabolic and immunological effects of fasting and plant-based diet (PBD) on patients with psoriasis (PsO) and psoriatic arthritis (PsA) on their gut microbiota. The project will combine clinical assessments, cytometric profiling, and gut microbiota analysis to explore the relationship between fasting, a plant-based diet, and psoriatic disease. The study includes a 7-day fasting period followed by 11 weeks of PBD, with the goal of improving disease activity, quality of life, and understanding the role of gut microbiota in these conditions. This approach could lead to low-cost, accessible therapeutic options with minimal side effects.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Active plaque psoriasis (PASI ≥3) or Psoriatic Arthritis fulfilling the Classification Criteria for Psoriatic Arthritis (CASPAR) and not meeting MDA criteria
* on stable baseline psoriatic treatment for 12 weeks before enrollment
* ≥ 18 years old
Exclusion Criteria:
* Pregnancy or breastfeeding
* underweight (BMI ≤18,5)
* eating disorder in the last 5 years
* severe internal diseases (e.g. renal insufficiency with creatinine \> 2mg/dl)
* current practice of vegan diet or fasting within the past 6 months
* use of antibiotics within the past 3 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying fasting as an intervention for psoriasis and psoriatic arthritis — can you help me understand what kind of fasting they're likely testing, and whether there are any safety concerns about fasting that would apply to my specific health situation?
2The trial is listed as 'active, not recruiting,' which means it's already underway but not taking new participants — do you know of any similar fasting-related studies I could actually enroll in, or is this one worth monitoring for future results?
3Since this study is listed as Phase NA — meaning it's more of an exploratory or observational study rather than a standard drug trial — what does that tell us about how much we can actually conclude from its findings about fasting as a real treatment option for me?
4The trial is measuring my type of outcomes — PASI for skin involvement and DAPSA for joint disease activity — so if results become available, how would you use those scores to judge whether fasting might genuinely be helping someone like me versus the treatments I'm currently on or considering?
5Before looking at something like a fasting study, should we first discuss whether standard treatments for my psoriasis or psoriatic arthritis have been fully explored, and how a dietary approach like fasting might fit alongside — or potentially interfere with — those options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Psoriasis Area and Severity Index (PASI)
Timeframe: Date of inclusion (baseline), day 8, after 6 and 12 weeks
2
Disease Activity index for PSoriatic Arthritis (DAPSA)
Timeframe: Date of inclusion (baseline), day 8, after 6 and 12 weeks