Probiotics as Adjunctive Migraine Prophylaxis

Migraine Clinical Trial

Official title:

The Effectiveness and Tolerability of Multi-Strain Probiotics as Adjunctive Preventive Treatment of Episodic Migraine: A Single Centre, Randomised, Double- Blind, Sham-Controlled Phase 2 Trial (PROBIOTICS -EM).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05042037
• Other study ID #: JKEUPM-2021-276
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: October 2022
• Source: Universiti Putra Malaysia
• Contact: Azliza Ibrahim, MMED
• Phone: +60172640768
• Email: azliza.i[@]upm.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety and efficacy of multi-strain probiotics as an adjunctive treatment for episodic migraine

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Episodic Migraine
• Migraine
• Migraine Disorders

Intervention

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)

Other:
• Placebo
Placebo sachet with no microbial cell preparation

Locations

Country	Name	City	State
Malaysia	University Putra Malaysia	Serdang	Selangor Darul Ehsan

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Reduction mean monthly migraine days(MMD)	Proportion of subjects with at least a 50% reduction from baseline in MMD	12 weeks post treatment
Secondary	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
Secondary	Adverse events in response to probiotics	Frequency and adverse events in response to (probiotics)	Week 4, 8 and 12 treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Serum Interleukin 6 (IL- 6)	Interleukin 6 (IL- 6) level changes in migraine patients in response to probiotics	Week 0 and 12 post treatment
Secondary	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
Secondary	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