Probiotics for Women's Health

Overseen By Faith C Adams, BSc

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: McMaster University

Must not be taking: Oral contraceptives

Disqualifiers: TMS contradictions, Probiotic contradictions, others

Compensation: Varies

Number of Visits: 4

Duration: 28 days

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Modulation of our gut microbiota through probiotics, can improve our emotional state, decrease pain sensitivity, improve cognitive processes, increase neurotransmitter levels and alter functional connectivity. In addition, probiotics regulate estrogen levels. Estrogen levels have been recognized to influence the gut microbiota, impact neural activity, memory, and cognition. This study aims 1) to determine whether probiotics can increase the propensity for synaptic plasticity in females and 2) to determine if there are differences in the propensity for plasticity depending on the phase of the menstrual cycle.

Eligibility Criteria

This trial is for women interested in exploring how probiotics might affect brain flexibility and health during their menstrual cycle. Participants should be generally healthy, with a regular menstrual cycle, not currently using probiotics or antibiotics, and without gastrointestinal issues.

Inclusion Criteria

I am a right-handed woman, aged 18-35, with a regular menstrual cycle of 26-30 days.

Exclusion Criteria

Contradictions to TMS

I use birth control pills or other hormone-based contraceptives.

Contradictions to probiotic

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a real probiotic or placebo probiotic for 28 days, with assessments conducted before and after each intervention.

28 days

4 visits (in-person)

Washout

A 28-day washout period between interventions to ensure no carryover effects.

28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Progressive Perfect Probiotic

Trial Overview The study tests if the 'Progressive Perfect Probiotic' can enhance brain adaptability more effectively than a placebo (a substance with no active therapeutic effect). It also examines whether these effects vary at different stages of the menstrual cycle.

Participant Groups

Group I: Active: Probiotic Active Control 1 Intervention

Progressive Perfect Probiotic 120 Billion CFU containing the following strains will be used: Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium animalis subsp.lactis, Bifidobacterium breve, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus reuteri, Bifidobacterium bifidum, Bifidobacterium longum subsp. Longum. Participants will be required to take one capsule a day, for 28 days.

Group II: Placebo Probiotic Placebo Group 1 Intervention

A placebo that is identical in capsule size and colour to the active probiotic capsule will be used. This will ensure participants and experimenters are masked during each intervention period. Participants will be required to take one capsule a day for 28 days.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+