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
30 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
This research aims to understand if increasing dietary fiber can improve the gut microbiome and reduce disease activity in adults with rheumatoid arthritis (RA). The study focuses on whether a higher fiber diet can enhance beneficial gut bacteria, produce helpful short-chain fatty acids (SCFAs), reduce RA symptoms, and support weight loss. Researchers will compare two groups: one receiving dietary counseling and daily psyllium husk supplementation, and another maintaining their usual diet. Participants in the intervention group will take 10 grams of psyllium husk daily along with dietary counseling, supported by regular phone calls to help with adherence. The control group will continue their usual diet without added fiber. The study lasts 12 months, with dietary intake, disease activity, body weight, and stool and blood samples collected at baseline, 6 months, and 12 months for analysis. Throughout the study, participants will complete dietary questionnaires and provide stool samples to assess gut bacteria and SCFA levels. Disease activity will be monitored using DAS28 and CRP measures alongside body weight checks. Blood tests will evaluate inflammation and metabolic markers. Researchers will analyze changes over time to determine the effects of increased dietary fiber on RA activity and patient health.
CONDITIONS
Brief 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 to participate
You will not qualify if you...
- Age under 18
- Lack of consent capability
- Insufficient knowledge of the German language
- 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 four weeks prior to study inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants are assigned to either a high-fiber diet intervention with dietary counseling and daily psyllium husk supplementation, or continue their usual diet as controls. The impact on gut microbiome, disease activity, and body weight is assessed.
3 visits (baseline, 6 months, and 12 months) for assessments
Trial Site Locations
Total: 1 location
1
University Würzburg
Würzburg, Germany, 97080
Actively Recruiting
Research Team
E
Eva C Schwaneck, M.D.
M
Michael Gernert, M.D.
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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