Fibromyalgia
Conditions
Interventions
GABA/Butyrate group:Purified GABA and butyrate in separately bottles respectively (Bottle 1 and Bottle 2). The patients will be instructed to take 1 capsule from Bottle 1 (500mg GABA) and 1 capsule fr
Synbiotics Group:GABA-producing Synbiotics (Bifidobacterium longum ATCC 51870 + Lactobacillus plantarum 299v + 500mg Fructooligosaccharides) and Butyrate-producing Synbiotics (Lactobacillus rhamnosus
Placebo Group:StarCap - a mixture of Pregelatinized Maize starch and maize starch. The patients will be provided with 2 bottles and instructed to take one capsule from each of the bottles twice a day
Sponsors
The Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| average of pain severity score; | — |
Secondary
| Measure | Time frame |
|---|---|
| average of pain severity score;pain interference score;Depression Anxiety Stress Scale;Pittsburgh Sleeping Quality Index;plasma GABA level;fecal GABA level;plasma butyrate level;fecal butyrate level;I-FABP level;bacterial DNA level;16S RNA gene sequencing ;fecal calprotectin ;metagenomic and metabolomic; | — |
Countries
China
Contacts
Public ContactMandy Hiu Man CHU
Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong
Outcome results
None listed