NCT06492200Recruiting
Impact of a High-fiber Diet on the Microbiome and Disease Activity in Patients With Rheumatoid Arthritis
Einfluss Ballaststoffreicher Ernährung Auf Das Mikrobiom Und Die Krankheitsaktivität Von Patientinnen Und Patienten Mit Rheumatoider Arthritis
Source: ClinicalTrials.gov · Last updated 9 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 1 Jul 2024
- Start date
- 1 Jun 2024
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Wuerzburg University Hospital
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06492200
What you commit to
- Study type: Interventional
- Planned participants: 52
- From 1 Jun 2024 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of ground psyllium husks four weeks prior to study inclusion
Other illness
- Chronic inflammatory bowel disease
- History of mechanical ileus
Age
- Age under 18
Other
- Lack of consent capability
- Insufficient knowledge of the German language
- Liver cirrhosis
- Patients with altered gastrointestinal passage (e.g., stoma patients)
- Use of antibiotics within the past three months
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Würzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.