Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492200
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
Impact of a High-fiber Diet on the Microbiome and Disease Activity in Patients With Rheumatoid Arthritis
Sponsor:
Wuerzburg University Hospital
Organization:
Wuerzburg University Hospital
Study Overview
Official Title:
Einfluss Ballaststoffreicher Ernährung Auf Das Mikrobiom Und Die Krankheitsaktivität Von Patientinnen Und Patienten Mit Rheumatoider Arthritis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Background and Rationale
Rheumatoid arthritis RA is an autoimmune disease characterized by chronic inflammation of the joints Emerging evidence indicates that the gut microbiome plays a crucial role in immune system modulation and may influence the development and progression of RA Dietary fibers are known to enhance the production of short-chain fatty acids SCFAs by gut bacteria which in turn can have beneficial effects on the immune system Studies have shown that SCFAs can prevent the onset of RA in animal models and reduce disease activity in humans at risk Additionally a fiber-rich diet has been associated with weight loss which is beneficial for RA patients as lower body weight is linked to reduced disease activity Despite recommendations from the German Society for Nutrition to consume 30 grams of dietary fiber daily most individuals fail to meet this target
Study Objectives and Hypotheses
The primary objectives of this study are to
1 Investigate the gut microbiome of patients with established RA and its relationship with disease activity and body weight
2 Assess whether increasing dietary fiber intake can favorably modify the gut microbiome and increase SCFA production
3 Determine the impact of a fiber-rich diet on RA disease activity and body weight over a 12-month period
The study hypothesizes that a diet higher in dietary fiber will lead to
Improved gut microbiome composition with increased SCFA production
Reduced RA disease activity as measured by DAS28 and CRP
Decreased body weight in overweight RA patients
Study Design
This is a randomized controlled parallel-group clinical trial conducted at the Rheumatology Clinic of the University Clinic Würzburg UKW Participants will be randomized into two groups an intervention group receiving dietary counseling and psyllium husk supplementation and a control group continuing their usual diet
Study Procedures
Recruitment
- Adult RA patients will be recruited from the Rheumaambulanz at UKW
Inclusion criteria age 18 years diagnosis of RA according to the 2010 American College of Rheumatology ACR criteria ability to consent
Exclusion criteria age 18 lack of consent ability insufficient German language skills chronic inflammatory bowel disease liver cirrhosis history of mechanical ileus altered gastrointestinal passage recent antibiotic use and recent use of psyllium husk
Interventions
- Intervention Group Participants will receive dietary counseling to increase fiber intake and will be asked to consume 10 grams of psyllium husk daily Regular phone calls will be made to support compliance
- Control Group Participants will maintain their usual diet without additional fiber supplementation
Data Collection
Dietary Habits Questionnaires will be administered at baseline 6 months and 12 months to assess dietary fiber intake protein content and fat consumption
Body Weight Participants will be weighed at baseline 6 months and 12 months
Disease Activity DAS28 and CRP levels will be measured at baseline 6 months and 12 months
Stool Samples Collected at baseline 6 months and 12 months for microbiome analysis and SCFA quantification
Blood Samples Routine blood tests including CRP erythrocyte sedimentation rate ESR and metabolic parameters will be evaluated
Laboratory Analysis
- Stool samples will be analyzed for microbial composition and SCFA content at the Hepatology Laboratory University Clinic Würzburg Samples will be stored and destroyed after 10 years
- Blood samples will be assessed for routine clinical parameters and lymphocyte characterization
Data Analysis
- The primary endpoint is the difference in DAS28-CRP scores between the intervention and control groups at 12 months
- Statistical tests include Mann-Whitney U for non-parametric data and Fishers exact test for categorical variables
A sample size of 52 participants 26 per group is calculated to detect a significant difference with 90 power accounting for a 20 dropout rate
Multivariate regression analysis will be used to control for potential confounders
Quality Assurance
- Data will be collected and stored in compliance with General Data Protection Regulation GDPR regulations
- Data will be pseudonymized for statistical analysis and anonymized for publication
- Regular monitoring and auditing will ensure data accuracy and protocol adherence
Ethics and Consent
- The study protocol patient information and consent forms will be reviewed and approved by the local ethics committee at the University Clinic Würzburg
Participation is voluntary and participants can withdraw at any time without any impact on their standard medical care
Publication
- Results will be published in peer-reviewed scientific journals in an anonymized format
Sponsorship
- The study is supported by RheinNatur Food GmbH which provides the psyllium husk for the intervention
This study aims to provide valuable insights into the potential benefits of a high-fiber diet for RA patients contributing to improved management strategies and patient outcomes
Rheumatoid arthritis RA is an autoimmune disease characterized by chronic inflammation of the joints Emerging evidence indicates that the gut microbiome plays a crucial role in immune system modulation and may influence the development and progression of RA Dietary fibers are known to enhance the production of short-chain fatty acids SCFAs by gut bacteria which in turn can have beneficial effects on the immune system Studies have shown that SCFAs can prevent the onset of RA in animal models and reduce disease activity in humans at risk Additionally a fiber-rich diet has been associated with weight loss which is beneficial for RA patients as lower body weight is linked to reduced disease activity Despite recommendations from the German Society for Nutrition to consume 30 grams of dietary fiber daily most individuals fail to meet this target
Study Objectives and Hypotheses
The primary objectives of this study are to
1 Investigate the gut microbiome of patients with established RA and its relationship with disease activity and body weight
2 Assess whether increasing dietary fiber intake can favorably modify the gut microbiome and increase SCFA production
3 Determine the impact of a fiber-rich diet on RA disease activity and body weight over a 12-month period
The study hypothesizes that a diet higher in dietary fiber will lead to
Improved gut microbiome composition with increased SCFA production
Reduced RA disease activity as measured by DAS28 and CRP
Decreased body weight in overweight RA patients
Study Design
This is a randomized controlled parallel-group clinical trial conducted at the Rheumatology Clinic of the University Clinic Würzburg UKW Participants will be randomized into two groups an intervention group receiving dietary counseling and psyllium husk supplementation and a control group continuing their usual diet
Study Procedures
Recruitment
- Adult RA patients will be recruited from the Rheumaambulanz at UKW
Inclusion criteria age 18 years diagnosis of RA according to the 2010 American College of Rheumatology ACR criteria ability to consent
Exclusion criteria age 18 lack of consent ability insufficient German language skills chronic inflammatory bowel disease liver cirrhosis history of mechanical ileus altered gastrointestinal passage recent antibiotic use and recent use of psyllium husk
Interventions
- Intervention Group Participants will receive dietary counseling to increase fiber intake and will be asked to consume 10 grams of psyllium husk daily Regular phone calls will be made to support compliance
- Control Group Participants will maintain their usual diet without additional fiber supplementation
Data Collection
Dietary Habits Questionnaires will be administered at baseline 6 months and 12 months to assess dietary fiber intake protein content and fat consumption
Body Weight Participants will be weighed at baseline 6 months and 12 months
Disease Activity DAS28 and CRP levels will be measured at baseline 6 months and 12 months
Stool Samples Collected at baseline 6 months and 12 months for microbiome analysis and SCFA quantification
Blood Samples Routine blood tests including CRP erythrocyte sedimentation rate ESR and metabolic parameters will be evaluated
Laboratory Analysis
- Stool samples will be analyzed for microbial composition and SCFA content at the Hepatology Laboratory University Clinic Würzburg Samples will be stored and destroyed after 10 years
- Blood samples will be assessed for routine clinical parameters and lymphocyte characterization
Data Analysis
- The primary endpoint is the difference in DAS28-CRP scores between the intervention and control groups at 12 months
- Statistical tests include Mann-Whitney U for non-parametric data and Fishers exact test for categorical variables
A sample size of 52 participants 26 per group is calculated to detect a significant difference with 90 power accounting for a 20 dropout rate
Multivariate regression analysis will be used to control for potential confounders
Quality Assurance
- Data will be collected and stored in compliance with General Data Protection Regulation GDPR regulations
- Data will be pseudonymized for statistical analysis and anonymized for publication
- Regular monitoring and auditing will ensure data accuracy and protocol adherence
Ethics and Consent
- The study protocol patient information and consent forms will be reviewed and approved by the local ethics committee at the University Clinic Würzburg
Participation is voluntary and participants can withdraw at any time without any impact on their standard medical care
Publication
- Results will be published in peer-reviewed scientific journals in an anonymized format
Sponsorship
- The study is supported by RheinNatur Food GmbH which provides the psyllium husk for the intervention
This study aims to provide valuable insights into the potential benefits of a high-fiber diet for RA patients contributing to improved management strategies and patient outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None