This study will assess the safety and efficacy of multi-strain probiotics as an adjunctive treatment for episodic migraine
This is a phase 2 and single center, randomized, placebo-controlled double-blind clinical Trial. Episodic migraine patients according to International Headache Society criteria will be allocated randomly into two treatment arms. One group will receive active probiotics and another group will receive placebo for treatment phase. Both groups of patients will consume the treatment twice daily for 12 weeks and assessment will be made at baseline, baseline, week 4, 8 and 12
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
Lactobacillus acidophilus (107mg), Lactobacillus casei subsp (107mg), Lactobacillus lactis (107mg), Bifidobacterium bifidum (107mg), Bifidobacterium infantis (107mg) and Bifidobacterium longum (107mg)
Placebo sachet with no microbial cell preparation
University Putra Malaysia
Serdang, Selangor, Malaysia
RECRUITINGChange from baseline in mean monthly migraine days (MMD).
The MMD will be calculated using the MMD recorded by patients in a headache diary from each of the months of the double-blind treatment phase.
Time frame: Baseline, week 4, 8 and 12 post treatment
Change from baseline in mean monthly migraine attacks
The mean monthly migraine attacks will be calculated using the monthly migraine attack recorded by patients in headache diaries from each of the months of the double-blind treatment phase
Time frame: Baseline, week 4, 8 and 12 post treatment
Reduction mean monthly migraine days(MMD)
Proportion of subjects with at least a 50% reduction from baseline in MMD
Time frame: 12 weeks post treatment
Change from baseline in mean monthly pain intensity of migraine attacks
The mean monthly pain intensity will be based on the record of the maximal pain intensity by means of a verbal scale (i.e., 0 =no headache; 1 = mild headache; 2 = moderate headache; 3 = severe headache) prior to taking symptomatic medication
Time frame: Baseline, week 4, 8 and 12 post treatment
Adverse events in response to probiotics
Frequency and adverse events in response to (probiotics)
Time frame: Week 4, 8 and 12 treatment
Change from baseline in mean Migraine Induced Disability Assessment Score (MIDAS)
Change from baseline in mean Migraine Induced Disability Assessment Score (MIDAS) in migraine patients in response to probiotics
Time frame: Week 0 and 12 post treatment
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Change from baseline in mean Depression, Anxiety and Stress Scale (DASS21)
Change from baseline in mean Depression, Anxiety and Stress Scale (DASS21) score in migraine patients in response to probiotics
Time frame: Week 0 and 12 post treatment
Change from baseline in mean Migraine-Specific Quality-of-Life Questionnaire (MSQ V2) score
Change from baseline in mean Migraine-Specific Quality-of-Life Questionnaire (MSQ V2) score in migraine patients in response to probiotics
Time frame: Week 0 and 12 post treatment
Serum Highly sensitive C-Reactive Protein (hs-CRP)
Highly sensitive C-Reactive Protein (hs-CRP) level changes in migraine patients in response to probiotics
Time frame: Week 0 and 12 post treatment
Serum Interleukin 6 (IL- 6)
Interleukin 6 (IL- 6) level changes in migraine patients in response to probiotics
Time frame: Week 0 and 12 post treatment
Serum Tumour Necrosis Factor Alpha (TNF-alpha)
Tumour Necrosis Factor Alpha (TNF-alpha) level changes in migraine patients in response to probiotics
Time frame: Week 0 and 12 post treatment
Satisfaction measures of efficacy, tolerability, safety, and expectations of probiotics among the participants
A 5-point, Likert scale will be used to evaluate satisfaction with probiotics in migraine prevention
Time frame: Week 0 and 12 post treatment