Can probiotics help in preventing migraine headache in children

Efficacy of Probiotic supplementation in preventing Migraine Headaches in Children. An Open Labelled Randomized Controlled Trial - PROMICH

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/083825

Enrollment

Registered

2025-04-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

None listed

Interventions

Intervention1: saccharomyces boulardii: Probiotic dose - 250 mg (saccharomyces boulardii)- Powder for oral suspension CNCM I-745 Control Intervention1: standard of care treatment given: The contr

Eligibility

Inclusion criteria

Inclusion criteria: Children between 6 years to 14 years fulfilling the criteria for Migraine according to ICHD-3

Exclusion criteria

Exclusion criteria: Children with headache due to some known secondary causes like infection, refractive error Children with known comorbidities like chronic renal, liver, heart and GIT diseases Any previous known allergies to probiotics, such as allergic reactions to probiotic products or a compromised immune system (due to cancer treatment, immunosuppressive therapy)

Design outcomes

Primary

Measure	Time frame
The primary outcome is the reduction in the number of headache episodes post-treatmentTimepoint: The outcome will be measured at 4 weeks and 8 weeks post treatment	—

Secondary

Measure	Time frame
1.Change in pain severity scores (Wong-Baker Scale). 2.Frequency of analgesic use during the study period. 3.Treatment adherence & any reported side effects 4. see the adherence & adverse effects of probiotics Timepoint: assessed at 4 weeks & 8 weeks of treatment	—

Countries

India

Contacts

Public ContactDr T Arun Babu

AIIMS Mangalagiri

sivakumarnaikb@gmail.com08099143251

Outcome results