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

NCT06492200 | Recruiting

• 1 other identifier: Wuerzburg University Hospital
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Disease Activity Score 28 (DAS28)

  The Disease Activity Score 28 (DAS28) is a composite measure used to assess the activity of rheumatoid arthritis (RA). It is calculated using the number of tender and swollen joints (out of 28 specified joints) and the patient's global health assessment. The DAS28 score ranges from 0 to 9.4, with higher scores indicating higher disease activity. This measure is widely used in clinical practice and research to monitor and evaluate the effectiveness of RA treatments.

  Measurements will be assessed at baseline, 6 months, and 12 months.

• C-Reactive Protein (CRP) Level

  C-reactive protein (CRP) level is a biomarker used to measure inflammation in the body. Elevated CRP levels are indicative of inflammation and are commonly seen in rheumatoid arthritis patients. CRP levels will be measured using blood tests to assess the inflammatory status of the participants.

  Measurements will be assessed at baseline, 6 months, and 12 months.

• Short-Chain Fatty Acids (SCFA) Levels in Stool

  The concentration of short-chain fatty acids (SCFAs) in stool samples will be measured. SCFAs, such as acetate, propionate, and butyrate, are produced by the gut microbiota through the fermentation of dietary fibers. These compounds play a crucial role in maintaining gut health and modulating the immune system. The levels of SCFAs will be analyzed to determine the impact of increased dietary fiber intake on gut microbiota composition and function.

  Measurements will be assessed at baseline, 6 months, and 12 months.

• Body Weight

  Participants' body weight will be measured to assess changes over the study period. Weight measurements will be taken using a standardized and calibrated scale. Changes in body weight will help determine the effect of increased dietary fiber intake on weight management in individuals with rheumatoid arthritis.

  Measurements will be assessed at baseline, 6 months, and 12 months.

Secondary Outcomes (4)

• Patient Global Assessment of Disease Activity

  Measurements will be assessed at baseline, 6 months, and 12 months.

• Health Assessment Questionnaire-Disability Index (HAQ-DI)

  Measurements will be assessed at baseline, 6 months, and 12 months.

• Erythrocyte Sedimentation Rate (ESR)

  Measurements will be assessed at baseline, 6 months, and 12 months.

• Changes in Gut Microbiome Composition

  Measurements will be assessed at baseline, 6 months, and 12 months.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Other: Psyllium husks

Control Group

NO INTERVENTION

Interventions

Psyllium husks OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age under 18
• Lack of consent capability
• Insufficient knowledge of the German language
• Chronic inflammatory bowel disease
• Liver cirrhosis
• History of mechanical ileus
• Patients with altered gastrointestinal passage (e.g., stoma patients)
• Use of antibiotics within the past three months

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• RheinNatur Food GmbH: collaborator

Study Sites (1)

University Würzburg

Würzburg, 97080, Germany

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eva C Schwaneck, M.D.

  University Wuerzburg

  PRINCIPAL INVESTIGATOR

• Monika Rau, M.D.

  University Wuerzburg

  STUDY CHAIR

• Michael Gernert, M.D.

  University Wuerzburg

  STUDY CHAIR

Central Study Contacts

Eva C Schwaneck, M.D.

CONTACT

+49 40 1818 81 8343; e.schwaneck@rheuma-hh.de

Michael Gernert, M.D.

CONTACT

+49 931 201 40 100; gernert_m1@ukw.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)