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Clinical effect and safety evaluation of fecal bacteria transplantation in patients with fibromyalgia syndrome

Clinical effect and safety evaluation of fecal bacteria transplantation in patients with fibromyalgia syndrome

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053176
Enrollment
Unknown
Registered
2021-11-13
Start date
2021-11-10
Completion date
Unknown
Last updated
2023-11-06

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

Conditions

fibromyalgia syndrome (FMS)

Interventions

Fecal transplant group:fecal microbiota transplantation
Oral drug group:oral drug

Sponsors

Shanghai East Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-60 years, males and females not restricted; 2. Patients with FMS who met the American College of Rheumatology (ACR) 2016 diagnostic criteria while being diagnosed for > 12 months; 3. Patient's pre-treatment Numerical Rating Scale (NRS)NRS score = 4; 4. Patient voluntarily signed the informed consent form and was able to cooperate to complete the questionnaire.

Exclusion criteria

Exclusion criteria: 1. Patients who were not amenable to treatment by colonoscopy, intravenous anesthesia, fecal transplantation for various reasons; 2. Patients with the spine surgical history; 3. Patients with massive blood loss, acute hemorrhage, anemia (HB < 90 g/L), thrombocytopenia less than 50*109/L and severe coagulopathy; 4. Patients with comorbid severe cardiac, hepatic, renal and metabolic diseases, psychiatric diseases and with a history of toxic substance exposure; 5. Patients with comorbidities of osteoarthritis, hypothyroidism, malignancy or other diseases; 6. Pregnant women, psychiatric patients or patients with other major illnesses; 7. Patients with poor compliance, nonadherence to medical treatment, rejected follow-up, etc.

Design outcomes

Primary

MeasureTime frame
pain;

Secondary

MeasureTime frame
motion;Sleep quality;Fatigue;Life quality;Fecal condition;Oral medication after fecal transplant;Treatment effectiveness;

Countries

China

Contacts

Public ContactLiao Lijun

Shanghai East Hospital

liao@pan-intelligence.com+86 138 1742 8913

Outcome results

None listed

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