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

NCT06492200 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-07-09

No results posted yet for this study

Summary

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

  • Arthritis, Rheumatoid

Interventions

OTHER

Psyllium husks

Patients in the intervention group will receive nutritional counseling and will be asked to take 10g (one tablespoon) of ground psyllium husks daily to significantly increase the fiber content of their diet.

Sponsors & Collaborators

  • RheinNatur Food GmbH

    collaborator UNKNOWN

  • Wuerzburg University Hospital

    lead OTHER

Principal Investigators

  • Eva C Schwaneck, M.D. · University Wuerzburg

  • Monika Rau, M.D. · University Wuerzburg

  • Michael Gernert, M.D. · University Wuerzburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2026-06-01
Completion
2026-12-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06492200 on ClinicalTrials.gov