Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202512709047685 Date of Registration: 10/12/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Can "Good Bacteria" Stop Migraines?
Official scientific title Evaluation of Probiotic Efficacy in Migraine: Clinical Correlation and Modulations of Neurotransmitters, Inflammation, and Oxidative Stress
Brief summary describing the background and objectives of the trial Migraines are a common, debilitating neurological disorder, presenting a major therapeutic challenge. Recently, probiotics have emerged as a promising approach, with studies suggesting their potential to reduce the frequency and intensity of migraine attacks. This efficacy is rooted in the complex interaction between the gut microbiota and the gut-brain axis, which modulates key mechanisms like inflammation, neurotransmission, and metabolic balance. For instance, a combination of probiotics and Vitamin D significantly reduced the frequency and intensity of attacks compared to a placebo (Tirani et al., 2024). Specific formulations also showed notable reductions in attacks and analgesic use in children (Bidabadi et al., 2023). The proposed mechanisms include restoring the balance of the gut microbiota, which is often altered in migraine patients, and modulating neuroinflammation through beneficial metabolites such as short-chain fatty acids (Kappéter et al., 2023; Gazerani et al., 2024). These scientific advances suggest that integrating probiotics into a comprehensive therapeutic strategy could represent an innovative and effective solution, offering new perspectives for migraine management, especially when combined with adapted dietary approaches (Prathiviraj et al., 2023).The primary objectives of this study are twofold: 1-Evaluate the efficacy of probiotics in migraine management by examining their impact on the frequency and intensity of attacks. 2-Study the changes in dietary habits and biological parameters (neurotransmitters, pro- and anti-inflammatory interleukins, and markers of oxidative stress) before and after probiotic supplementation.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 07/12/2025
Actual trial start date
Anticipated date of last follow up 01/12/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation Sequence/Code was not concealed Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group probiotic 3 months Migraine patients were supplemented with a product (containing $10^{10}$ Colony Forming Units (CFU)) that included four strains of probiotics:bifidobacterium\ longum Lactobacillus\ helveticus Lactococcus\ lactis Streptococcus\ thermophilus Each participant was instructed to take one capsule per day on an empty stomach, approximately 30 minutes before breakfast, for a duration of 12 weeks. 20
Control Group placebo 3 months Migraine patients in the control group received a placebo (containing starch). They were instructed to take one capsule per day for a duration of 12 weeks. 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants were required to meet the following criteria to be enrolled in the study: Migraine patients diagnosed according to the criteria established by the International Headache Society (IHS). The diagnosis must be confirmed by neurologists at the Mongi Ben Hamida Neurology Hospital. Age between 18 and 65 years old. Availability to participate in all assessments both before and after the supplementation period. Signed informed consent Patients presenting with any of the following conditions or circumstances were excluded from participating in the trial: Pregnancy or breastfeeding. History of neurological diseases other than migraine. Current use of probiotics or treatments likely to influence the gut microbiota, such as antibiotics or immunosuppressive drugs. Severe chronic diseases (e.g., kidney failure, liver failure, or unstable cancer). Patients who did not provide informed consent to participate in the study. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 64 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/09/2025 ethical commitee of institut pasteur
Ethics Committee Address
Street address City Postal code Country
13 place pasteur tunis 1002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Migraine Attack Frequency and Intensity post intervention
Secondary Outcome biological parameters (neurotransmitters, pro- and anti-inflammatory interleukins, and markers of oxidative stress) before and after probiotic supplementation. post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
institute of neurology mongi ben hmida tunis tunisia 15 rue jbal lakhdhar tunis Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
institut de nutrition de tunis 11 rue jbal lakhdhar tunis Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor none none tunis Tunisia none
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator rym ben othman benothmanr@gmail.com +21699907402 11 rue jbal lakhdhar
City Postal code Country Position/Affiliation
tunis Tunisia university of tunis el manar faculty of medicine of tunis
Role Name Email Phone Street address
Public Enquiries rym ben othman rym.benothman@fmt.utm.tn +21652262806 11 rue jbal lakhdhar
City Postal code Country Position/Affiliation
tunis Tunisia institut national de nutrition et de technologie alimentaire de tunis
Role Name Email Phone Street address
Scientific Enquiries said glai said.galai@fmt.utm.tn +21699907402 15 rue la rabta
City Postal code Country Position/Affiliation
tunis Tunisia institut de neurologie de tunis
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Will IPD be shared? Yes. The authors and the sponsor are committed to making the data available to qualified researchers for secondary analysis to promote scientific discovery and reproducibility. 2. What data will be shared? The following materials will be shared upon request: The de-identified Individual Participant Data (IPD) (excluding identifying information such as names or dates of birth) necessary to reproduce the published results, covering all outcome measures (migraine frequency/intensity, dietary habits, and biological markers). The full study protocol and the Statistical Analysis Plan (SAP). A Data Dictionary to define all variables and coding. 3. When will the data be available? Data will be made available upon reasonable request starting nine months after the publication of the primary manuscript, and will remain available for a period of five years. 4. With whom will the data be shared? Data will be shared only with qualified scientific researchers whose proposed use of the data is scientifically and ethically sound, and whose request has been approved by an independent Data Access Committee (DAC). The purpose of the DAC is to ensure that the proposed research adheres to ethical guidelines and respects patient confidentiality. 5. By what mechanism will the data be made available? Data will be shared via a secure, managed online platform or a secure file transfer system. Researchers will be required to sign a Data Use Agreement (DUA) guaranteeing the data will be used solely for the approved research purpose and will not be redistributed. 6. Does the informed consent permit sharing? Yes. All participants signed an Informed Consent Form that explicitly granted permission for the de-identified data to be shared with other researchers for future scientific inquiry. Statistical Analysis Plan,Study Protocol The individual participant data will be available for controlled sharing with qualified researchers between 9 months and 5 years after the official publication date of the study. The request must include a complete and well-justified research protocol clearly outlining the research question, the methodology (including the statistical analysis plan), and the objectives for reusing the data. The scientific merit of the proposal must be judged sufficient by the Data Access Committee (DAC). Ethical Approval and Compliance: The researcher must provide proof of ethical approval (or an exemption) from their own institutional Research Ethics Committee (REC). The researcher must commit to handling the data in an anonymous and confidential manner, in line with the original participants' Informed Consent. Signing a Data Use Agreement (DUA): The applicant must sign a legally binding Data Use Agreement with the study sponsor. This DUA specifies that the data can only be used for the approved research purpose, will not be shared with unauthorized third parties, and that no attempt at re-identification of participants will be made. Declaration of Conflict of Interest (COI): Applicants must disclose any actual or potential conflicts of interest relevant to the proposed analysis, including funding from pharmaceutical or food industries. They must guarantee adequate IT security measures for the storage and handling of the de-identified data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information