Effects of Probiotics on Synaptic Plasticity During the Menstrual Cycle

NCT06213428 | Unknown Phase 1

• 1 other identifier: 16602
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Women's Health; Brain Plasticity

Keywords

Probiotic

Outcome Measures

Primary Outcomes (1)

• Change Motor Evoked Potentials (MEPs)

  Change in MEPs using TMS

  Immediately before intervention, immediately following 4 week intervention

Secondary Outcomes (1)

• Short Interval intracortical inhibition (SICI)

  Immediately before intervention, immediately following 4 week intervention

Study Arms (2)

Active: Probiotic

ACTIVE COMPARATOR

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.

Biological: Progressive Perfect Probiotic

Placebo Probiotic

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Progressive Perfect Probiotic BIOLOGICAL

Participants will be administered an active probiotic for 28 days. Participants will be blinded as to what intervention they are experiencing.

Active: Probiotic

Placebo OTHER

Participants will be administered a placebo for 28 days. Participants will be blinded as to what intervention they are experiencing.

Placebo Probiotic

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• right handed, females between 18-35 years old with a regular menstrual cycle (approximately 26-30 days)

You may not qualify if:

• contradictions to TMS
• contradictions to probiotic
• Females who use hormone altering devices (i.e. oral contraceptives)

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster Unviersity

Hamilton, Ontario, L8S 4K1, Canada

Location

Central Study Contacts

Aimee J Nelson, PhD

CONTACT

9055259140; nelsonaj@mcmaster.ca

Faith C Adams, BSc

CONTACT

adamsf4@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: all investigators and participants will be masked to which condition they receive
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 19, 2024
• Study Start: January 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 19, 2024

Record last verified: 2024-01

Locations

CA (1)