MigraineNCT05042037
Probiotics as Adjunctive Migraine Prophylaxis
A study testing (Microbial cell preparation) probiotics in people with Migraine and Episodic Migraine, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
This study will assess the safety and efficacy of multi-strain probiotics as an adjunctive treatment for episodic migraine Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Migraine, Episodic Migraine
- What is being tested?
- (Microbial cell preparation) probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Oct 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Onset of headache more than 50 years
- Prior GI infection in the previous 3-months
- Morbid obesity (BMI >40)
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University Putra Malaysia
Serdang, Selangor, 43400
Wan Aliaa Wan Sulaiman, FRCP, 603 8609 2980, wanaliaa@upm.edu.my
Azliza Ibrahim, MMed, 0172640768, azliza.i@upm.edu.my
About this study
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).
This study will assess the safety and efficacy of multi-strain probiotics as an adjunctive treatment for episodic migraine
Read the 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
- Conditions
- Migraine, Episodic Migraine
- Being tested
- (Microbial cell preparation) probiotics, Placebo
- Keywords
- Episodic migraine, probiotics, effectiveness, preventive treatment, randomized controlled trial.
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Microbial cell preparation) probioticsDietary supplement
Also called Granulated Multi-strain Probiotics, Hexbio
Lactobacillus acidophilus (107mg), Lactobacillus casei subsp (107mg), Lactobacillus lactis (107mg), Bifidobacterium bifidum (107mg), Bifidobacterium infantis (107mg) and Bifidobacterium longum (107mg)
PlaceboOther
Placebo sachet with no microbial cell preparation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 4, 8 and 12 post treatment
Secondary outcomes (11)
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
Measured: Baseline, week 4, 8 and 12 post treatment
Reduction mean monthly migraine days(MMD)
Proportion of subjects with at least a 50% reduction from baseline in MMD
Measured: 12 weeks post treatment
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
Measured: Baseline, week 4, 8 and 12 post treatment
Adverse events in response to probiotics
Frequency and adverse events in response to (probiotics)
Measured: Week 4, 8 and 12 treatment
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
Measured: Week 0 and 12 post treatment
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
Measured: Week 0 and 12 post treatment
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
Measured: Week 0 and 12 post treatment
Serum Highly sensitive C-Reactive Protein (hs-CRP)
Highly sensitive C-Reactive Protein (hs-CRP) level changes in migraine patients in response to probiotics
Measured: Week 0 and 12 post treatment
Serum Interleukin 6 (IL- 6)
Interleukin 6 (IL- 6) level changes in migraine patients in response to probiotics
Measured: Week 0 and 12 post treatment
Serum Tumour Necrosis Factor Alpha (TNF-alpha)
Tumour Necrosis Factor Alpha (TNF-alpha) level changes in migraine patients in response to probiotics
Measured: Week 0 and 12 post treatment
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
Measured: Week 0 and 12 post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Oct 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel assignment involves two groups of participants. One group receives probiotics , and the other group receives placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan Aliaa Wan Sulaiman, Universiti Putra Malaysia
- Investigators
- Hamidon Basri, AM, Study chair, Universiti Putra MalaysiaWan Aliaa Wan Sulaiman, FRCP, Principal investigator, Universiti Putra MalaysiaAzliza Ibrahim, MMed, Study director, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042037
- Sponsor's protocol ID
- JKEUPM-2021-276
- Status last verified
- Oct 2022
- First submitted
- 3 Sep 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT05042037
- Acronym / sponsor ID
- JKEUPM-2021-276
- Conditions
- Migraine, Episodic Migraine
- Keywords
- Episodic migraine, probiotics, effectiveness, preventive treatment, randomized controlled trial.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel assignment involves two groups of participants. One group receives probiotics , and the other group receives placebo.
| Arm | Type | Receives |
|---|---|---|
| Double-blind, placebo-controlled interventional study | Active comparator | Dietary Supplement: (Microbial cell preparation) probioticsActive 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. |
| Placebo | Placebo comparator | Other: PlaceboPatients will be given placebo sachet (exactly the same packaging as active comparator) to be taken 1 sachet twice daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (Microbial cell preparation) probioticsAlso: Granulated Multi-strain Probiotics, HexbioLactobacillus acidophilus (107mg), Lactobacillus casei subsp (107mg), Lactobacillus lactis (107mg), Bifidobacterium bifidum (107mg), Bifidobacterium infantis (107mg) and Bifidobacterium longum (107mg) | Dietary supplement | Double-blind, placebo-controlled interventional study |
| PlaceboPlacebo sachet with no microbial cell preparation | Other | Placebo |
Primary outcome
Change from baseline in mean monthly migraine days (MMD).
Time frame: Baseline, week 4, 8 and 12 post treatment
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.
11 secondary outcomes
Change from baseline in mean monthly migraine attacks
Time frame: Baseline, week 4, 8 and 12 post treatment
Reduction mean monthly migraine days(MMD)
Time frame: 12 weeks post treatment
Change from baseline in mean monthly pain intensity of migraine attacks
Time frame: Baseline, week 4, 8 and 12 post treatment
Adverse events in response to probiotics
Time frame: Week 4, 8 and 12 treatment
Change from baseline in mean Migraine Induced Disability Assessment Score (MIDAS)
Time frame: Week 0 and 12 post treatment
Change from baseline in mean Depression, Anxiety and Stress Scale (DASS21)
Time frame: Week 0 and 12 post treatment
Change from baseline in mean Migraine-Specific Quality-of-Life Questionnaire (MSQ V2) score
Time frame: Week 0 and 12 post treatment
Serum Highly sensitive C-Reactive Protein (hs-CRP)
Time frame: Week 0 and 12 post treatment
Serum Interleukin 6 (IL- 6)
Time frame: Week 0 and 12 post treatment
Serum Tumour Necrosis Factor Alpha (TNF-alpha)
Time frame: Week 0 and 12 post treatment
Satisfaction measures of efficacy, tolerability, safety, and expectations of probiotics among the participants
Time frame: Week 0 and 12 post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamidon Basri, AM study chair
Universiti Putra Malaysia
Wan Aliaa Wan Sulaiman, FRCP principal investigator
Universiti Putra Malaysia
Azliza Ibrahim, MMed study director
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (Microbial cell preparation) probiotics in people with Migraine and Episodic Migraine, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Azliza Ibrahim, MMED (+60172640768 ext. 60134888405, azliza.i@upm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in mean monthly migraine days (MMD). (time frame: Baseline, week 4, 8 and 12 post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.