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Clinical study of fecal bacteria transplantation in the treatment of fibromyalgia syndrome

Clinical study of fecal bacteria transplantation in the treatment of fibromyalgia syndrome

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077086
Enrollment
Unknown
Registered
2023-10-28
Start date
2023-10-28
Completion date
Unknown
Last updated
2023-10-30

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

Conditions

Fibromyalgia syndrome

Interventions

Group pharmacotherapy and fecal bacteria transplantation:pharmacotherapy and fecal bacteria transplantation
Group pharmacotherapy:pharmacotherapy

Sponsors

Dongfang Hospital Affiliated to Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1.Age 18-79years old, male and female; 2. Patients with FMS who met the diagnostic criteria of the 2016 American College of Rheumatology diagnostic criteria (ACR2016): The diagnosis can be met by fulfilling 3 of the following: 1) Widespread Pain Index (WPI) >7 and Symptom Severity Score (SSS) >5; or WPI=3-6 and SSS >=9; 2) Widespread pain: defined as symptoms of pain in at least 4 of the 5 regions of the body; jaw, chest, and abdominal pain are not included in widespread pain; 3) Symptoms have generally been present for at least 3 months 4) The diagnosis of fibromyalgia is independent of other diagnoses. The diagnosis of fibromyalgia does not exclude the presence of other clinically significant diseases. 3. The patient's NRS score was greater than or equal to 4 points before treatment 4.Patients voluntarily signed an informed consent form and were able to cooperate in completing the questionnaire.

Exclusion criteria

Exclusion criteria: 1. Patients who are not suitable for enteroscopy and fecal transplantation treatment for various reasons; 2. Exclude other lesions such as cervical and lumbar spine lesions (nerve root compression, spinal stenosis, cervical and lumbar degenerative changes), cerebral infarction, Guillain - Barre syndrome, severe arterial and venous vascular lesions (venous embolism, lymphadenitis), etc., and still need to identify the neurotoxic effects caused by the drugs, especially chemotherapeutic drugs, as well as the metabolic poisons on the nerves caused by renal insufficiency. 3. Patients with massive blood loss, acute bleeding, anemia (<90 g/L), thrombocytopenia less than 50*109/L, and severe coagulation dysfunction; 4. Patients with combination of serious heart, liver, kidney and metabolic diseases, patients with mental diseases, patients with history of toxic substance use; 5. Those secondary to osteoarthritis, hypothyroidism, malignant tumors and other diseases; 6. Pregnant women, psychiatric patients, and patients with other major diseases 7. Patients with poor compliance, non-compliance with medical advice, non-acceptance of follow-up visits, etc; 8. Patients who fall off or miss visits during the follow-up process.

Design outcomes

Primary

MeasureTime frame
Numerical Rating Scale,NRS;

Secondary

MeasureTime frame
Symptom Severity, SS;The Hospital Anxiety and Depress-ionor Scale, HADS;Intestinal flora 16SRNA sequences;Pittsburgh sleep quality index ,PSQI;Pittsburgh sleep quality?index ,PSQI;the multidimensional fatigue inventory (MFI);Widespread Pain Index, WPI;

Countries

China

Contacts

Public ContactLiao Lijun

Dongfang Hospital Affiliated to Tongji University

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

Outcome results

None listed

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