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Probiotics as Adjunctive Migraine Prophylaxis

Primary Purpose

Migraine, Episodic Migraine

Status

Recruiting

Phase

Not Applicable

Locations

Malaysia

Study Type

Interventional

Intervention

(Microbial cell preparation) probiotics

Placebo

About this trial

This is an interventional treatment trial for Migraine focused on measuring Episodic migraine, probiotics, effectiveness, preventive treatment, randomized controlled trial.

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

University Putra MalaysiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Double-blind, placebo-controlled interventional study

Placebo

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Reduction mean monthly migraine days(MMD)

Proportion of subjects with at least a 50% reduction from baseline in MMD

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

Adverse events in response to probiotics

Frequency and adverse events in response to (probiotics)

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

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

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

Serum Highly sensitive C-Reactive Protein (hs-CRP)

Highly sensitive C-Reactive Protein (hs-CRP) level changes in migraine patients in response to probiotics

Serum Interleukin 6 (IL- 6)

Interleukin 6 (IL- 6) level changes in migraine patients in response to probiotics

Serum Tumour Necrosis Factor Alpha (TNF-alpha)

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

A 5-point, Likert scale will be used to evaluate satisfaction with probiotics in migraine prevention

Full Information

NCT ID

NCT05042037

First Posted

September 3, 2021

Last Updated

October 31, 2022

Sponsor

Universiti Putra Malaysia

1. Study Identification

Unique Protocol Identification Number

NCT05042037

Brief Title

Probiotics as Adjunctive Migraine Prophylaxis

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).

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2022 (Actual)

Primary Completion Date

October 1, 2023 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universiti Putra Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine, Episodic Migraine

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The participants, care provider, investigator and outcome assessor of the study is blinded about the allocation status of the participants (Double blinded)

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Double-blind, placebo-controlled interventional study

Arm Type

Active Comparator

Arm 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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

(Microbial cell preparation) probiotics

Other Intervention Name(s)

Granulated Multi-strain Probiotics, Hexbio

Intervention Description

Lactobacillus acidophilus (107mg), Lactobacillus casei subsp (107mg), Lactobacillus lactis (107mg), Bifidobacterium bifidum (107mg), Bifidobacterium infantis (107mg) and Bifidobacterium longum (107mg)

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo sachet with no microbial cell preparation

Primary Outcome Measure Information:

Title

Change from baseline in mean monthly migraine days (MMD).

Description

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.

Time Frame

Baseline, week 4, 8 and 12 post treatment

Secondary Outcome Measure Information:

Title

Change from baseline in mean monthly migraine attacks

Description

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

Time Frame

Baseline, week 4, 8 and 12 post treatment

Title

Reduction mean monthly migraine days(MMD)

Description

Proportion of subjects with at least a 50% reduction from baseline in MMD

Time Frame

12 weeks post treatment

Title

Change from baseline in mean monthly pain intensity of migraine attacks

Description

Time Frame

Baseline, week 4, 8 and 12 post treatment

Title

Adverse events in response to probiotics

Description

Frequency and adverse events in response to (probiotics)

Time Frame

Week 4, 8 and 12 treatment

Title

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

Description

Change from baseline in mean Migraine Induced Disability Assessment Score (MIDAS) in migraine patients in response to probiotics

Time Frame

Week 0 and 12 post treatment

Title

Change from baseline in mean Depression, Anxiety and Stress Scale (DASS21)

Description

Change from baseline in mean Depression, Anxiety and Stress Scale (DASS21) score in migraine patients in response to probiotics

Time Frame

Week 0 and 12 post treatment

Title

Change from baseline in mean Migraine-Specific Quality-of-Life Questionnaire (MSQ V2) score

Description

Change from baseline in mean Migraine-Specific Quality-of-Life Questionnaire (MSQ V2) score in migraine patients in response to probiotics

Time Frame

Week 0 and 12 post treatment

Title

Serum Highly sensitive C-Reactive Protein (hs-CRP)

Description

Highly sensitive C-Reactive Protein (hs-CRP) level changes in migraine patients in response to probiotics

Time Frame

Week 0 and 12 post treatment

Title

Serum Interleukin 6 (IL- 6)

Description

Interleukin 6 (IL- 6) level changes in migraine patients in response to probiotics

Time Frame

Week 0 and 12 post treatment

Title

Serum Tumour Necrosis Factor Alpha (TNF-alpha)

Description

Tumour Necrosis Factor Alpha (TNF-alpha) level changes in migraine patients in response to probiotics

Time Frame

Week 0 and 12 post treatment

Title

Satisfaction measures of efficacy, tolerability, safety, and expectations of probiotics among the participants

Description

A 5-point, Likert scale will be used to evaluate satisfaction with probiotics in migraine prevention

Time Frame

Week 0 and 12 post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Azliza Ibrahim, MMED

Phone

+60172640768

Ext

60134888405

azliza.i@upm.edu.my

First Name & Middle Initial & Last Name or Official Title & Degree

Hrishikesa Kumar, MBBS

Phone

+0174888979

hrishikesa87@ymail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hamidon Basri, AM

Organizational Affiliation

University Putra Malaysia

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Wan Aliaa Wan Sulaiman, FRCP

Organizational Affiliation

University Putra Malaysia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Azliza Ibrahim, MMed

Organizational Affiliation

Universiti Putra Malaysia

Official's Role

Study Director

Facility Information:

Facility Name

University Putra Malaysia

City

Serdang

State/Province

Selangor Darul Ehsan

ZIP/Postal Code

43400

Country

Malaysia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wan Aliaa Wan Sulaiman, FRCP

Phone

603 8609 2980

wanaliaa@upm.edu.my

First Name & Middle Initial & Last Name & Degree

Azliza Ibrahim, MMed

Phone

0172640768

azliza.i@upm.edu.my

First Name & Middle Initial & Last Name & Degree

Azliza Ibrahim, MMED

First Name & Middle Initial & Last Name & Degree

Anna Misyail Rashid, MMED

12. IPD Sharing Statement

Plan to Share IPD

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