Probiotics as Adjunctive Migraine Prophylaxis

Not Applicable

Recruiting

• Conditions: Migraine; Episodic Migraine
• Interventions: Other: Placebo; Dietary Supplement: (Microbial cell preparation) probiotics

• Registration Number: NCT05042037
• Lead Sponsor: Universiti Putra Malaysia

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

Study Timeline

• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-13
• Status Verified: 2022-10
• Study Start: 2022-10-01
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-03
• Primary Completion: 2023-10-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients will be given placebo sachet (exactly the same packaging as active comparator) to be taken 1 sachet twice daily for 12 weeks.
Double-blind, placebo-controlled interventional study	(Microbial cell preparation) probiotics	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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
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
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 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
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
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

Trial Locations

Locations (1)

University Putra Malaysia; 🇲🇾 Serdang, Selangor Darul Ehsan, Malaysia