Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
NCT06492200

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

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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