Clinical trial NCT05042037: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine
Episodic Migraine
Keywords: Episodic migraine, probiotics, effectiveness, preventive treatment, randomized controlled trial.
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm parallel assignment involves two groups of participants. One group receives probiotics , and the other group receives placebo.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in mean monthly migraine days (MMD).
timeFrame: Baseline, week 4, 8 and 12 post treatment
Secondary outcomes:
measure: Change from baseline in mean monthly migraine attacks
timeFrame: Baseline, week 4, 8 and 12 post treatment
measure: Reduction mean monthly migraine days(MMD)
timeFrame: 12 weeks post treatment
measure: Change from baseline in mean monthly pain intensity of migraine attacks
timeFrame: Baseline, week 4, 8 and 12 post treatment
measure: Adverse events in response to probiotics
timeFrame: Week 4, 8 and 12 treatment
measure: Change from baseline in mean Migraine Induced Disability Assessment Score (MIDAS)
timeFrame: Week 0 and 12 post treatment
measure: Change from baseline in mean Depression, Anxiety and Stress Scale (DASS21)
timeFrame: Week 0 and 12 post treatment
measure: Change from baseline in mean Migraine-Specific Quality-of-Life Questionnaire (MSQ V2) score
timeFrame: Week 0 and 12 post treatment
measure: Serum Highly sensitive C-Reactive Protein (hs-CRP)
timeFrame: Week 0 and 12 post treatment
measure: Serum Interleukin 6 (IL- 6)
timeFrame: Week 0 and 12 post treatment
measure: Serum Tumour Necrosis Factor Alpha (TNF-alpha)
timeFrame: Week 0 and 12 post treatment
measure: Satisfaction measures of efficacy, tolerability, safety, and expectations of probiotics among the participants
timeFrame: Week 0 and 12 post treatment
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: University Putra Malaysia
state: Selangor Darul Ehsan
Study officials:
affiliation: University Putra Malaysia
name: Hamidon Basri, AM
role: STUDY_CHAIR
affiliation: University Putra Malaysia
name: Wan Aliaa Wan Sulaiman, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Putra Malaysia
name: Azliza Ibrahim, MMed
role: STUDY_DIRECTOR
References: