The Effect of Probiotics on the Frequency and Intensity of Migraine Attacks and Intestinal Permeability

Migraine Clinical Trial

— Promi2  

Official title:

The Effects of Probiotics on the Frequency and Intensity of Migraine Attacks and Intestinal Permeability. A Placebo-controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02342262
• Other study ID #: NL46401.081.13
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 9, 2015
• Last updated: January 14, 2015
• Start date: August 2014
• Est. completion date: October 2015

Study information

• Verified date: January 2015
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

RATIONALE: The prevalence of migraine is higher in patients with various intestinal diseases. An explanation could be that migraine is caused by a 'leaky gut': an increased intestinal permeability that allows food particles to pass the gastrointestinal wall. Probiotics may be able to improve intestinal barrier function.

OBJECTIVE: To test whether probiotics, as adjuvant therapy, can reduce incidence and severity of migraine attacks by reducing intestinal permeability.

STUDY DESIGN: 12-week placebo-controlled randomized double-blind intervention with selected probiotics.

STUDY POPULATION: Adults who experience at least 4 migraine attacks per month. INTERVENTION:

Subjects will receive either one daily dose of 2 g of Ecologic® Barrier or 2 grams of the placebo, containing only the carrier material (both provided by Winclove Probiotics).

MAIN STUDY PARAMETERS/ENDPOINTS: Incidence and severity of migraine attacks, measured by diaries and validated headache questionnaires will be measured at baseline and after 4, 8, and 12 weeks of probiotic/placebo administration. Secondary, intestinal permeability will be measured by the lactulose/mannitol absorption test in urine (screening, baseline and 12 weeks) and by fecal zonulin (baseline, 4, 8, and 12 weeks). Inflammation will be assessed from blood C-reactive protein and cytokine concentrations (baseline, 4, 8, and 12 weeks). Fecal samples will also be used for microbial analysis.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects confirm to have migraine characterized by :

• Recurrent attacks of moderate to severe headaches, often one-sided and pounding, often with nausea and/or vomiting, aggravated by physical activity

• Sensitivity for light or sounds is possible but not exclusive.

• Attacks last for 4 to 72 hours.

• Self-reported frequency of migraine attacks (or days) at least 4 per month

• Fairly predictable/stable pattern of migraine attacks (frequency, duration, intensity)

• Age = 18 years

• Good overall health (self-reported in medical questionnaire)

Exclusion Criteria:

• Migraine patients who suffer from chronic daily migraine/headaches

• Migraine patients who suffer from medication-dependent headaches

• Subjects who suffer from cluster headache or tension-type headaches

• Subjects who used antibiotics up to two months before the start of the study

• Subjects who are unwilling to stop taking probiotics other than study products

• Patients with a chronic use of non steroid anti inflammatory drugs (because of increased gut permeability)

• Patients with inflammatory bowel diseases (because of increased gut permeability)

• Pregnancy or lactation (because of their possible effect on migraine incidence)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Dietary Supplement:
• EcologicBarrier
multispecies probiotic product, 2x10-9 cfu/gram

Other:
• Placebo
similar appearance as the probiotic product, but without bacteria

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of migraine attacks		12 weeks	No
Secondary	Intestinal permeability	Lactulose/mannitol in urine, zonulin in serum	12 weeks	No
Secondary	Inflammation markers.	pro-inflammatory cytokines in serum	12 weeks	No