Probiotics as Adjunctive Migraine Prophylaxis

NCT05042037 | Unknown DMC

• 1 other identifier: JKEUPM-2021-276
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine; Episodic Migraine

Keywords

Episodic migraine, probiotics, effectiveness, preventive treatment, randomized controlled trial.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change from baseline in mean monthly migraine attacks

  Baseline, week 4, 8 and 12 post treatment

• Reduction mean monthly migraine days(MMD)

  12 weeks post treatment

• Change from baseline in mean monthly pain intensity of migraine attacks

  Baseline, week 4, 8 and 12 post treatment

• Adverse events in response to probiotics

  Week 4, 8 and 12 treatment

• Change from baseline in mean Migraine Induced Disability Assessment Score (MIDAS)

  Week 0 and 12 post treatment

Study Arms (2)

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.

Dietary Supplement: (Microbial cell preparation) probiotics

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.

Other: Placebo

Interventions

(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)

Also known as: Granulated Multi-strain Probiotics, Hexbio

Double-blind, placebo-controlled interventional study

Placebo OTHER

Placebo sachet with no microbial cell preparation

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects fulfilling criteria for episodic migraine as per the Third Edition of The International Headache Society (ICHD-3) (Table 1)
• Patients diagnosed with episodic migraine (4 or more episodes per month) for a minimum of 3 months.
• On a steady treatment regimen: preventive and acute migraine medications and therapies unchanged over the last 3 months
• Adult patients Age \> 18 years old
• 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.

You may not qualify if:

• Lactose intolerance
• Previous history of small and large bowel surgery
• Use of probiotics or antibiotics in 2 weeks before baseline visit.
• Patients with medical conditions such as severe hypertension, infections,
• Malignancy, cardiovascular and cerebrovascular diseases, epilepsy, degenerative central nervous system diseases, renal failure, hepatic failure, bleeding diathesis and serious mental illnesses
• Headache with red flags symptoms that may suggest organic secondary headaches.
• Onset of headache more than 50 years
• Prior GI infection in the previous 3-months
• Morbid obesity (BMI \>40)
• Pregnant or lactating women

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

University Putra Malaysia

Serdang, Selangor, 43400, Malaysia

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Hamidon Basri, AM

  University Putra Malaysia

  STUDY CHAIR

• Wan Aliaa Wan Sulaiman, FRCP

  University Putra Malaysia

  PRINCIPAL INVESTIGATOR

• Azliza Ibrahim, MMed

  Universiti Putra Malaysia

  STUDY DIRECTOR

Central Study Contacts

Azliza Ibrahim, MMED

CONTACT

+60172640768; azliza.i@upm.edu.my

Hrishikesa Kumar, MBBS

CONTACT

+0174888979; hrishikesa87@ymail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, care provider, investigator and outcome assessor of the study is blinded about the allocation status of the participants (Double blinded)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Two-arm parallel assignment involves two groups of participants. One group receives probiotics , and the other group receives placebo.

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 13, 2021
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2024
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)