A Randomized Controlled Trial for Comparing Two Diets in the Treatment of migraine

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900028110

Enrollment

Unknown

Registered

2019-12-12

Start date

2019-12-01

Completion date

Unknown

Last updated

2019-12-16

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

Conditions

migraine

Interventions

1:free diet

2:traditional dietary elimination (no alcohol, chocolate, caffeine, preserved foods, MSG, citrus fruits))

3:intolerance food elimination (if there are more than 2 intolerance food, fasting ? 2, + 3 food, rotation to eat + 1 food)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 to 65 years; 2. Migraine patients meet the diagnostic criteria of ICHD-IIR1, have been diagnosed for more than 6 months and have occurred at least twice in the previous month; 3. Of the 14 foods tested with the specific IgG antibody test, at least one food tested must be positive (the specific IgG antibody is greater than 50 U/mL; 4. Each patient shall agree to strictly follow the food elimination diet, follow up truthfully, complete symptom score questionnaire, return visit regularly to collect blood, stool sample.

Exclusion criteria

Exclusion criteria: 1. Unable to carry out the assigned experimental scheme strictly due to lack of autonomy; Unable to follow up on time; 2. Fasting food (because of allergy, ketogenic diet, vegetarian, etc.); 3. Use of antibiotics, microecological regulators or antifungal agents within 12 weeks prior to taking a stool sample; 4. Other diagnosed conditions that cause headache symptoms (such as hypertension, tumors, stroke, etc.).

Design outcomes

Primary

Measure	Time frame
The Migraine Disability Assessment questionnaire MIDAS score;Headache Impact Test-6 score;specific IgG antibody titer of 14 kinds food;Abundance and diversity of intestinal microbiota;	—

Secondary

Measure	Time frame
body weight;The Migraine Disability Assessment questionnaire MIDAS score;Self-Rating Anxiety Scale, SAS score;Self-Rating Depression Scale, SDS score;Pittsburgh sleep quality index, PSQI score;Gastrointestinal Symptom Rating Scale, GSRS score;	—

Countries

China

Contacts

Public ContactZhao Zhiming

the First Affiliated Hospital of Harbin Medical University

xmzaixian2001@163.com+86 13895709101

Outcome results

None listed

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