【ChiCTR2500115868】Effects of GABA with Butyrate, GABA/Butyrate-producing Synbiotics on Pain Relief in Fibromyalgia: A Phase II, Multi-Center, Double-Blinded, Randomized-Controlled Trial
ChiCTR2500115868
尚未开始
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2025-12-31
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Fibromyalgia
Effects of GABA with Butyrate, GABA/Butyrate-producing Synbiotics on Pain Relief in Fibromyalgia: A Phase II, Multi-Center, Double-Blinded, Randomized-Controlled Trial
Effects of GABA with Butyrate, GABA/Butyrate-producing Synbiotics on Pain Relief in Fibromyalgia: A Phase II, Multi-Center, Double-Blinded, Randomized-Controlled Trial
Objective: We would like to show that 1) combination of GABA and butyrate as a supplement and 2) GABA-butyrate producing synbiotics can reduce pain in patients with fibromyalgia better than placebo. With the effects on vagus nerves and enteric nervous system, GABA-butyrate or its producing synbiotics may also improve the functional outcomes of fibromyalgia patients with the interference of pain.
随机平行对照
Ⅱ期
Block randomization will be used in our trial. We are aware that it is a multicentre trial involving 7 pain centres in Hong Kong in which the inter-centre variability is unlikely to be negligible. The randomization will be stratified in each center so to have similar distribution of each study arm in each center
This is a double-blinded study in which both the assessors and the patients will be blinded. The bottles, though not completely identical between different arms, the content would not be distinguishable by the appearance of the bottles. Labelling will show only the study arms and bottle A or B respectively.
Peter Hung Pain Research Institute
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50
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2026-01-02
2028-03-31
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1. Patients who are >=18 years old, under care of the pain clinics in the collaborating hospitals; 2. FM has been diagnosed according to the revised 2016 American College of Rheumatology (ACR) Preliminary Diagnostic Criteria for FM, and 3. Able to provide written informed consent and agree to adhere to the trial protocol and follow-up schedule for 12 months, including the 3-monthly follow-up for half a year and a follow-up at 1 year.；
请登录查看1. Pregnant; 2. Known history of allergic reactions to maize, probiotics or prebiotics; 3. Using prebiotics and/ or probiotics within 15 days before enrolment; 4. Immunocompromised with (a) active chemotherapy or immunotherapy or (b) chronic leukopenia (with cell count < 4x10^9/L) within 3 months of enrolment.；
请登录查看The Chinese University of Hong Kong
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