NCT06492200 Impact of a High-fiber Diet on the Microbiome and Disease Activity in Patients With Rheumatoid Arthritis
| NCT ID | NCT06492200 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wuerzburg University Hospital |
| Condition | Arthritis, Rheumatoid |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 52 participants in total. It began in 2024-06-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if increasing dietary fiber can improve the gut microbiome and reduce disease activity in adults with rheumatoid arthritis (RA). The main questions it aims to answer are: * Can a higher fiber diet improve gut bacteria and produce beneficial short-chain fatty acids (SCFAs)? * Does a higher fiber diet reduce RA symptoms and help with weight loss? Researchers will compare two groups: one group will receive dietary counseling and take 10 grams of psyllium husk daily, while the other group will continue their usual diet. Participants will: * Complete dietary questionnaires at the start, 6 months, and 12 months. * Provide stool samples for gut bacteria and SCFA analysis. * Have their RA activity and body weight monitored regularly. * Receive regular phone calls to support the dietary changes. The study will involve adults with diagnosed RA who can provide informed consent and meet other inclusion criteria.
Eligibility Criteria
Inclusion Criteria: * Patients over 18 years old * Diagnosis of Rheumatoid Arthritis according to the ACR criteria of 2010 * The patient can understand the scope of the study and consents in writing to participate. Exclusion Criteria: * Age under 18 * Lack of consent capability * Insufficient knowledge of the German language * Chronic inflammatory bowel disease * Liver cirrhosis * History of mechanical ileus * Patients with altered gastrointestinal passage (e.g., stoma patients) * Use of antibiotics within the past three months * Use of ground psyllium husks four weeks prior to study inclusion
Contact & Investigator
Eva C Schwaneck, M.D.
PRINCIPAL INVESTIGATOR
University Wuerzburg
Frequently Asked Questions
Who can join the NCT06492200 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Arthritis, Rheumatoid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06492200 currently recruiting?
Yes, NCT06492200 is actively recruiting participants. Contact the research team at e.schwaneck@rheuma-hh.de for enrollment information.
Where is the NCT06492200 trial being conducted?
This trial is being conducted at Würzburg, Germany.
Who is sponsoring the NCT06492200 clinical trial?
NCT06492200 is sponsored by Wuerzburg University Hospital. The principal investigator is Eva C Schwaneck, M.D. at University Wuerzburg. The trial plans to enroll 52 participants.