Probiotics for the Prophylaxis of Migraine

Migraine Clinical Trial

— MIGR_PRO2  

Official title:

A Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Two Probiotic Interventions For The Prophylaxis of Migraine in Patients Diagnosed With Episodic Migraine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04305522
• Other study ID #: MIGR_PRO.2
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: May 2, 2021

Study information

• Verified date: March 2020
• Source: Biopolis S.L.
• Contact: María Empar Chenoll, PhD
• Phone: +34 673 53 53 44
• Email: maria.chenoll[@]adm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to understand the efficacy of two probiotic interventions as prophylaxes of migraine symptoms in individuals diagnosed with episodic migraine.

The primary outcome measure will be migraine days per month, but secondary outcome measures such as use of analgesia, the wider impact of migraine (as assessed through the HIT-6 score) will also be assessed. Finally adverse effects will be evaluated.

The study will have three arms: two arms including the two different probiotic preparations and a third placebo arm.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: May 2, 2021
• Est. primary completion date: February 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age between 18 - 65 years.

2. Signature of informed consent by the patient.

3. Patients with confirmed migraine, diagnosed by a neurologist

4. Patient-indicated frequency of migraine attacks (or days) of at least 4 per month.

5. Fairly predictable and stable pattern of migraine attacks (frequency, duration, intensity)

Exclusion Criteria:

1. Patients diagnosed with chronic migraine

2. Migraine patients suffering from medication-dependent headaches.

3. Patients suffering from cluster or tension-related headaches.

4. Patients who used antibiotics up to two weeks before the start of the study.

5. Patients who have taken other probiotics in the previous two months.

6. Patients with chronic use of non-steroidal anti-inflammatory drugs.

7. Patients with inflammatory bowel disease (due to increased intestinal permeability).

8. Patients who are pregnant, breastfeeding or who do not commit to using an effective method of contraception during the course of the study.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Dietary Supplement:
• Probiotic 1
Probiotic mixture with maltodextrin as a carrier.
• Placebo
Placebo comparator with maltodextrin as a carrier.
• Probiotic 2
Probiotic mixture with maltodextrin as a carrier.

Locations

Country	Name	City	State
Spain	Hospital Universitario del Vinalopó	Elche	Alicante
Spain	Hospital Universitario de Torrevieja	Torrevieja	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Biopolis S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days with migraine episodes	Number of days with migraine episodes in weeks 4	4-week
Primary	Number of days with migraine episodes	Number of days with migraine episodes, in weeks 8	8-week
Primary	Number of days with migraine episodes	Number of days with migraine episodes, in weeks 12.	12-week
Secondary	Number of migraine episodes	Number of migraine episodes, in weeks 4	4 weeks
Secondary	Number of migraine episodes	Number of migraine episodes, in weeks 8	8 weeks
Secondary	Number of migraine episodes	Number of migraine episodes, in weeks 12.	12 weeks
Secondary	Number of days that each patient requires the administration analgesia	Number of days that each patient requires the administration analgesia, in weeks 4	4 weeks
Secondary	Number of days that each patient requires the administration analgesia	Number of days that each patient requires the administration analgesia, in weeks 8	8 weeks
Secondary	Number of days that each patient requires the administration analgesia	Number of days that each patient requires the administration analgesia, in weeks 12	12 weeks
Secondary	Headache Impact Test (HIT-6) score	Headache Impact Test (HIT-6) score at weeks 0 and 4 Little or no impact (46 or less) Some impact (50 -55) Substantial impact (56-59) Severe impact (60-78)	4 weeks
Secondary	Headache Impact Test (HIT-6) score	Headache Impact Test (HIT-6) score at weeks 8 Little or no impact (46 or less) Some impact (50 -55) Substantial impact (56-59) Severe impact (60-78)	8 weeks
Secondary	Headache Impact Test (HIT-6) score	Headache Impact Test (HIT-6) score at weeks 12 Little or no impact (46 or less) Some impact (50 -55) Substantial impact (56-59) Severe impact (60-78)	12 weeks
Secondary	Treatment adherence rate	Treatment adherence rate using the returned capsules.	12 weeks
Secondary	Number of adverse events	Numbre od adverse effects reported	12 weeks
Secondary	Adherence to the treatment.	Percentage of treatment intake days.	12 weeks