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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-blind, placebo-controlled interventional study | Active Comparator | Active treatment group will receive a 3-gram sachet of probiotics containing multi-strain of lactobacillus and Bifidobacterium 30 Colony Forming Unit x 109 to be taken twice daily for 12 weeks. |
|
| Placebo | Placebo Comparator | Patients will be given placebo sachet (exactly the same packaging as active comparator) to be taken 1 sachet twice daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (Microbial cell preparation) probiotics | Dietary Supplement | Lactobacillus acidophilus (107mg), Lactobacillus casei subsp (107mg), Lactobacillus lactis (107mg), Bifidobacterium bifidum (107mg), Bifidobacterium infantis (107mg) and Bifidobacterium longum (107mg) |
| Measure | Description | Time Frame |
|---|---|---|
| Change 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. | Baseline, week 4, 8 and 12 post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, week 4, 8 and 12 post treatment |
| Reduction mean monthly migraine days(MMD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Azliza Ibrahim, MMED | Contact | +60172640768 | 60134888405 | azliza.i@upm.edu.my |
| Hrishikesa Kumar, MBBS | Contact | +0174888979 | hrishikesa87@ymail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hamidon Basri, AM | University Putra Malaysia | Study Chair |
| Wan Aliaa Wan Sulaiman, FRCP | University Putra Malaysia | Principal Investigator |
| Azliza Ibrahim, MMed |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Putra Malaysia | Recruiting | Serdang | Selangor | 43400 | Malaysia |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Two-arm parallel assignment involves two groups of participants. One group receives probiotics , and the other group receives placebo.
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The participants, care provider, investigator and outcome assessor of the study is blinded about the allocation status of the participants (Double blinded)
|
| Placebo | Other | Placebo sachet with no microbial cell preparation |
|
Proportion of subjects with at least a 50% reduction from baseline in MMD |
| 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 | Baseline, week 4, 8 and 12 post treatment |
| Adverse events in response to probiotics | Frequency and adverse events in response to (probiotics) | 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 | Week 0 and 12 post treatment |
| 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 | 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 | 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 | Week 0 and 12 post treatment |
| Serum Interleukin 6 (IL- 6) | Interleukin 6 (IL- 6) level changes in migraine patients in response to probiotics | 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 | 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 | Week 0 and 12 post treatment |
| Universiti Putra Malaysia |
| Study Director |
| D009422 | Nervous System Diseases |
| D019602 |
| Food and Beverages |