Episodic Migraine, Migraine
Conditions
Keywords
Episodic migraine, probiotics, effectiveness, preventive treatment, randomized controlled trial.
Brief summary
This study will assess the safety and efficacy of multi-strain probiotics as an adjunctive treatment for episodic migraine
Detailed description
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
Interventions
DIETARY_SUPPLEMENT(Microbial cell preparation) probiotics
Lactobacillus acidophilus (107mg), Lactobacillus casei subsp (107mg), Lactobacillus lactis (107mg), Bifidobacterium bifidum (107mg), Bifidobacterium infantis (107mg) and Bifidobacterium longum (107mg)
OTHERPlacebo
Placebo sachet with no microbial cell preparation
Sponsors
Universiti Putra Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The participants, care provider, investigator and outcome assessor of the study is blinded about the allocation status of the participants (Double blinded)
Intervention model description
Two-arm parallel assignment involves two groups of participants. One group receives probiotics , and the other group receives placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects fulfilling criteria for episodic migraine as per the Third Edition of The International Headache Society (ICHD-3) (Table 1) 2. Patients diagnosed with episodic migraine (4 or more episodes per month) for a minimum of 3 months. 3. On a steady treatment regimen: preventive and acute migraine medications and therapies unchanged over the last 3 months 4. Adult patients Age \> 18 years old 5. A signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study including any known and potential risks and available alternative treatments.
Exclusion criteria
1. Lactose intolerance 2. Previous history of small and large bowel surgery 3. Use of probiotics or antibiotics in 2 weeks before baseline visit. 4. Patients with medical conditions such as severe hypertension, infections, 5. Malignancy, cardiovascular and cerebrovascular diseases, epilepsy, degenerative central nervous system diseases, renal failure, hepatic failure, bleeding diathesis and serious mental illnesses 6. Headache with red flags symptoms that may suggest organic secondary headaches. 7. Onset of headache more than 50 years 8. Prior GI infection in the previous 3-months 9. Morbid obesity (BMI \>40) 10. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in mean monthly migraine days (MMD). | Baseline, week 4, 8 and 12 post treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in mean monthly migraine attacks | Baseline, week 4, 8 and 12 post treatment | 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 |
| Reduction mean monthly migraine days(MMD) | 12 weeks post treatment | Proportion of subjects with at least a 50% reduction from baseline in MMD |
| Change from baseline in mean monthly pain intensity of migraine attacks | Baseline, week 4, 8 and 12 post treatment | 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 |
| Adverse events in response to probiotics | Week 4, 8 and 12 treatment | Frequency and adverse events in response to (probiotics) |
| Change from baseline in mean Migraine Induced Disability Assessment Score (MIDAS) | Week 0 and 12 post treatment | Change from baseline in mean Migraine Induced Disability Assessment Score (MIDAS) in migraine patients in response to probiotics |
| Serum Tumour Necrosis Factor Alpha (TNF-alpha) | Week 0 and 12 post treatment | Tumour Necrosis Factor Alpha (TNF-alpha) level changes in migraine patients in response to probiotics |
| Change from baseline in mean Migraine-Specific Quality-of-Life Questionnaire (MSQ V2) score | Week 0 and 12 post treatment | Change from baseline in mean Migraine-Specific Quality-of-Life Questionnaire (MSQ V2) score in migraine patients in response to probiotics |
| Serum Highly sensitive C-Reactive Protein (hs-CRP) | Week 0 and 12 post treatment | Highly sensitive C-Reactive Protein (hs-CRP) level changes in migraine patients in response to probiotics |
| Serum Interleukin 6 (IL- 6) | Week 0 and 12 post treatment | Interleukin 6 (IL- 6) level changes in migraine patients in response to probiotics |
| Satisfaction measures of efficacy, tolerability, safety, and expectations of probiotics among the participants | Week 0 and 12 post treatment | A 5-point, Likert scale will be used to evaluate satisfaction with probiotics in migraine prevention |
| Change from baseline in mean Depression, Anxiety and Stress Scale (DASS21) | Week 0 and 12 post treatment | Change from baseline in mean Depression, Anxiety and Stress Scale (DASS21) score in migraine patients in response to probiotics |
Countries
Malaysia
Contacts
Primary ContactAzliza Ibrahim, MMED
Backup ContactHrishikesa Kumar, MBBS
Outcome results
None listed