Actively Recruiting
Impact of a High-fiber Diet on the Microbiome and Disease Activity in Patients With Rheumatoid Arthritis
Led by Wuerzburg University Hospital · Updated on 2024-07-09
52
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
Sponsors
W
Wuerzburg University Hospital
Lead Sponsor
R
RheinNatur Food GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of a High-fiber Diet on the Microbiome and Disease Activity in Patients With Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old
- Diagnosis of Rheumatoid Arthritis according to the ACR criteria of 2010
- Ability to understand the study and provide written consent
You will not qualify if you...
- Age under 18
- Unable to provide consent
- Insufficient German language skills
- Chronic inflammatory bowel disease
- Liver cirrhosis
- History of mechanical ileus
- Altered gastrointestinal passage (e.g., stoma patients)
- Use of antibiotics within the past three months
- Use of ground psyllium husks within four weeks prior to study enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Würzburg
Würzburg, Germany, 97080
Actively Recruiting
Research Team
E
Eva C Schwaneck, M.D.
CONTACT
M
Michael Gernert, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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