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Intervention study of resistant starch regulating intestinal microecology in patients with preclinical rheumatoid arthritis

Study on the regulation of intestinal microecology and mucosal immunity by type II resistant starch in the early development of rheumatoid arthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064987
Enrollment
Unknown
Registered
2022-10-25
Start date
2022-10-31
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

Experiment group:Type II resistant starch
Control group:common starch

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 30 to = 1 joint swelling and/or pain, with or without morning stiffness) and duration >= 2 weeks; 4. The patient had no previous history of rheumatic diseases, such as rheumatoid arthritis, systemic lupus erythematosus, etc. 5. The patient had not used anti-rheumatic drugs (DMARDs, including biological agents) to improve the condition; 6. Patients have not used glucocorticoids; 7. Patients who did not participate in any drug trial within 3 months before enrollment; 8. Patients voluntarily participated in the trial, had good compliance and were able to understand and sign informed consent before the study.

Exclusion criteria

Exclusion criteria: 1. Pregnant women, women preparing for pregnancy or lactation; 2. Patients with a history of chronic diarrhea or peptic ulcer in the past 1 year; 3. People with mental disorders, a history of alcoholism, drug or other substance abuse; 4. Joint symptoms are caused by other known causes (including but not limited to osteoarthritis, gout, infection, etc.); 5. Patients with malignant tumors; 6. Allergic or contraindicated to test drugs; 7. There are various other cases in which investigators consider it impossible to join the clinical trial.

Design outcomes

Primary

MeasureTime frame
Changes in the proportion of patients diagnosed with RA according to the revised (2010) ACR after treatment;

Secondary

MeasureTime frame
The total number of tender joints (TJC) and the total number of swollen joints (SJC) in the total number of 28 joints were changed;Changes of serum anti-cyclic citrulline antibody (ACPAs) levels;Changes of serum inflammatory response protein (CRP, ESR) level;Changes of intestinal flora and fecal metabolome;

Countries

China

Contacts

Public ContactLiu Yi

West China Hospital of Sichuan University

yi2006liu@163.com+86 18980602061

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026