Gut Microbiome Composition and Response to Probiotic Intervention in Patients with Fibromyalgia using a Neurobiological Approach

Investigate the effect of probiotic supplementation on pain,sleep ,intestinal composition in patients with Fibromyalgia.

Present study was designed in two phases : in this phase , the composition of intestinal microbiome and biomarkers - inflammatory markers in female patients with Fibromyalgia ( based on ACR-2016) were compared with healthy group matche in terms of age and body mass index (BMI). Blood and feces samples from both groups are collected and analyzed to identify disbiosispatterns and inflammatory markers. in the second phase (double - blind clinical trial ) , the patient participants were randomly divided into two intervention groups ( receiving probiotic lactobacillus rhamnosus and Bifidobacterium longum ) and control group ( placebo ) for 8 weeks .in both groups ,blood and feces samples were collected in two times ( before and after the intervention ) . Severity of pain , sleep quality , and mental status were assessed with the standard questionnaires ( vas , BPI , HADS , and PSQI ) at both times .also , the levels of inflammatory cytokines (Il - 6 ,TNF- α, CRP, bdnf ) and intestinal metabolites ( SCFA ) will be measured .

Imam khomeini hospital complex

Patients : women aged 55 - 18 ( based on acr - 2016 criteria ) . Controls ( case - control part ) : healthy women , age and BMI

* daily intake of a probiotic capsule containing : - Lactobacillus rhamnosus (10 cfu) - Bifidobacterium longum (10 cfu) Time : 8 weeks

1. Pain intensity 2. Sleep quality 3. Gut microbiome composition 4. Levels of inflammatory markers (IL-6, TNF-α, CRP) 5. Gut metabolites (short-chain fatty acids)

1.Details of the Randomization Process: In this study, randomization is performed by allocating patients to intervention and control groups using random blocks in a 1:1 ratio. This method ensures that the distribution of patients in each group is random and unbiased. 2.Linguistic Consistency on Both Sides: In the design and reporting of this study, all terms and expressions have been applied consistently and harmoniously on both sides to ensure that there is no ambiguity in the interpretation of the results. 3.Randomization Method: In this study, the randomization method is precisely determined by allocating patients using random blocks and implementing double blinding (so that both patients and researchers are unaware of group assignments). Additionally, the supplements are coded and packaged by an independent individual to prevent any bias.

Description of the Blinding Method: In this study, double blinding is fully implemented. This means that both patients and researchers will be unaware of group assignments. Patients are randomly allocated to the intervention and control groups, and all information related to the groups is managed in a coded manner by an independent individual. This person is responsible for the packaging and distribution of the supplements, ensuring that they have no knowledge of the type of intervention the patients receive. This approach ensures that there is no bias in the assessment of the results. Linguistic Consistency on Both Sides: All terms and expressions have been used consistently and harmoniously on both sides (Persian and English) to ensure that there is no ambiguity in the interpretation of the findings.

I haven 't decided yet - the release schedule is not yet clear .