Impact of a High-fiber Diet on the Microbiome and Disease Activity in Patients With Rheumatoid Arthritis

Recruiting now · Not applicable

Conditions studied: Arthritis, Rheumatoid

In brief

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.

Key facts

Study ID

NCT06492200

Run by

Wuerzburg University Hospital

People needed

52

Starts

2024-06-01

Expected to finish

2026-12-30

Last updated by the study team

2024-07-09

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University Würzburg — Würzburg, Germany (enrolling)

Full record on ClinicalTrials.gov

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