The effect of synbiotic supplement in migraine

The effect of synbiotic supplementation on inflammatory status, oxidative stress, intestinal permeability, clinical features and mood in women with migraine

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20121216011763N45

Enrollment

Registered

2020-04-22

Start date

2020-07-22

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine. Migraine without aura

Interventions

Intervention 1: Intervention group: Two capsule of synbiotic 500 mg daily half an hour before dinner and lunch for 12 weeks. Intervention 2: Control group: Two capsule of starch 500 mg daily half an h

Eligibility

Sex/Gender

Female

Age

20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Patients who agree to participate in the study Diagnosis of migraine by a neurologist according to ICHD-3 Aged between 20 to 50 years old

Exclusion criteria

Exclusion criteria: Non-compliance with dietary recommendations and supplements(Use less than 80% of the prescribed supplement) Reaction and sensitivity to the prescribed supplement Lack of referral in different stages of study

Design outcomes

Primary

Measure	Time frame
Migraine symptoms (severity, frequency, duration of migraine). Timepoint: At baseline and after 12 weeks. Method of measurement: Questionnaire (Visual analogue scale (VAS) and Clinical examination).;Serum levels of Zonulin. Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits.;Serum levels of High sensitive C-reactive protein (Hs-CRP). Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits.	—

Measure

Time frame

Migraine symptoms (severity, frequency, duration of migraine). Timepoint: At baseline and after 12 weeks. Method of measurement: Questionnaire (Visual analogue scale (VAS) and Clinical examination).;Serum levels of Zonulin. Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits.;Serum levels of High sensitive C-reactive protein (Hs-CRP). Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits.

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Secondary

Measure	Time frame
Depression, stress, anxiety. Timepoint: At baseline and after 12 weeks. Method of measurement: DASS-21questionnaire.;Quality of Life in Migraine Patients. Timepoint: At baseline and after 12 weeks. Method of measurement: Migraine –Specific Quality of Life(MSQ)questionnaire.;Serum Nitric Oxide. Timepoint: At baseline and after 12 weeks. Method of measurement: biochemical kit of KiaZist Co.;Total antioxidant capacity. Timepoint: At baseline and after 12 weeks. Method of measurement: biochemical kit of KiaZist Co.;Total oxidant status. Timepoint: At baseline and after 12 weeks. Method of measurement: biochemical kit of KiaZist Co.	—

Measure

Time frame

Depression, stress, anxiety. Timepoint: At baseline and after 12 weeks. Method of measurement: DASS-21questionnaire.;Quality of Life in Migraine Patients. Timepoint: At baseline and after 12 weeks. Method of measurement: Migraine –Specific Quality of Life(MSQ)questionnaire.;Serum Nitric Oxide. Timepoint: At baseline and after 12 weeks. Method of measurement: biochemical kit of KiaZist Co.;Total antioxidant capacity. Timepoint: At baseline and after 12 weeks. Method of measurement: biochemical kit of KiaZist Co.;Total oxidant status. Timepoint: At baseline and after 12 weeks. Method of measurement: biochemical kit of KiaZist Co.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAbed ghavami

Esfahan University of Medical Sciences

abedghavami@gmail.com+98 31 1792 2110

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026