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Effects of Synbiotic Supplementation on Migraine Headache

Effects of Synbiotic Supplementation on the Migraine Headache Characteristics in Adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201706239157N6
Enrollment
100
Registered
2017-07-26
Start date
2016-11-21
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Chronic and Episodic Migraine. Migraine

Interventions

Intervention 1: Synbiotic Group: Of 100 migraine patients, 25 subjects with chronic migraine and 25 subjects with episodic migraine will receive 2 capsules of protexin synbiotic supplement daily for 8
Treatment - Drugs
Placebo
Synbiotic Group: Of 100 migraine patients, 25 subjects with chronic migraine and 25 subjects with episodic migraine will receive 2 capsules of protexin synbiotic supplement daily for 8 weeks. The sup
Control Group: Of 100 migraine patients, 25 subjects with chronic migraine and 25 subjects with episodic migraine will receive 2 capsules of placebo with the same smell and taste as protexin supplem

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Willingness to participate in the study; Age range between 18 to 60 years old; Diagnosis of chronic and episodic migraine headache according to the International Classification of Headache Disorders, 3rd edition (ICHD3 beta) criteria; Passing more than three months from migraine diagnosis; Migraine headache with more than 15 attacks per month for chronic migraine patients; Migraine headache with 3-15 attacks per month for episodic migraine patients; Not taking a synbiotic supplement or foods which fortified by Synbiotic two months before entering the study. Exclusion criteria: Taking anti-psychotic drugs and/or antibiotic drugs during 2 months before the study; Pregnancy (or having a planned pregnancy); Lactation; Unwillingness to participate or continue the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of migraine headache. Timepoint: before and two months after the intervention. Method of measurement: headache diary and examination by neurologist.;Frequency of migraine attacks per month. Timepoint: before and two months after the intervention. Method of measurement: headache diary and examination by neurologist.;Duration of migraine headache. Timepoint: before and two months after the intervention. Method of measurement: headache diary and examination by neurologist.

Secondary

MeasureTime frame
The number of abortive drugs taken. Timepoint: before and two months after the intervention. Method of measurement: questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Soodeh Razeghi Jahromi

School of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research In

razeghi@sina.tums.ac.ir+98 21 22357

Outcome results

None listed

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