Probiotics as Adjunctive Migraine Prophylaxis

University of Putra Malaysia (UPM)

Status: Enrolling

Conditions: Migraine; Episodic Migraine

Treatments: Dietary Supplement: (Microbial cell preparation) probiotics; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05042037

JKEUPM-2021-276

Details and patient eligibility

About

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

Full 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

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

Double-blind, placebo-controlled interventional study

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: (Microbial cell preparation) probiotics

Placebo

Placebo Comparator group

Description:

Patients will be given placebo sachet (exactly the same packaging as active comparator) to be taken 1 sachet twice daily for 12 weeks.

Treatment:

Other: Placebo