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Probiotics as Adjunctive Migraine Prophylaxis | Clinical Trials | Clareo Health

UNKNOWNNA

Probiotics as Adjunctive Migraine Prophylaxis

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).

NCT05042037•Universiti Putra Malaysia

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 60 years

Sex

ALL

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

Locations (1)

University Putra Malaysia

Serdang, Selangor, Malaysia

Key Dates

Start Date

October 1, 2022

Primary Completion Date

October 1, 2023

Completion Date

December 1, 2024

Last Updated

November 3, 2022

Enrollment

ESTIMATED participants

Conditions

MigraineEpisodic Migraine

Interventions

(Microbial cell preparation) probiotics

DIETARY_SUPPLEMENT

Placebo

OTHER

Contacts

Azliza Ibrahim, MMED

CONTACT

+60172640768 azliza.i@upm.edu.my

Hrishikesa Kumar, MBBS

CONTACT

+0174888979 hrishikesa87@ymail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 3, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Probiotics as Adjunctive Migraine Prophylaxis

Inclusion Criteria

Exclusion Criteria

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