- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07219498
- Original Trial
Effects of a 5-Week Probiotic Supplementation Intervention on Markers of Delayed Onset Muscle Soreness
April 30, 2026 updated by: University of Minnesota
The purpose of this study is to evaluate how probiotic supplementation (PS) influences post-exercise recovery in healthy, physically active young adults.
Researchers aim to determine if the Lactobacillus casei probiotic strain reduces symptoms of delayed onset muscle soreness (DOMS) based on perceived muscle soreness, pressure pain threshold, and power output following exercise induced muscle damage (EIMD).
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jakob Fischer
- Phone Number: 507-236-8051
- Email: fisc0887@d.umn.edu
Study Locations
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota
-
Contact:
- Jakob Fischer
- Phone Number: 507-236-8051
- Email: fisc0887@d.umn.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- complete a minimum of 150 minutes a week of at least moderate intensity exercise in either an endurance-based or resistance-based training style based on a self-reported physical activity over the past month
- good general health with no injuries or health conditions that would affect physical activity
- willing to abstain from consistent NSAID use and other probiotic supplements over the course of this study
Exclusion Criteria:
- known musculoskeletal injuries or physical limitations that could interfere with performing the designated physical activity required
- underlying conditions that could place them at an increased risk during exercise such as cardiovascular, respiratory, or metabolic diseases
- currently take a probiotic supplement, are prescribed and taking an antibiotic during the intervention, or report using NSAIDs or steroids within the recovery time window
- report using an NSAID more than twice a week on a regular basis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo Group
|
The brand name of placebo capsules that will be used in this study is Magic Bullet Placebo Capsules.
This placebo is manufactured by Progressive Placebo as stated on the product label.
|
|
Active Comparator: Probiotic Group
|
Probiohealth is the manufacturer of this strain and they use a stringent quality control program that utilizes a multi point product variability check system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in perceived muscle soreness
Time Frame: From baseline to post 5-week intervention
|
Visual Analog Scale for perceived muscle soreness Each number on the scale will be designated with a descriptive word that corresponds to the soreness level they are experiencing.
The scale will be laid out in order of increasing muscle soreness with "1" representing no pain.
|
From baseline to post 5-week intervention
|
|
Change in pressure pain threshold (PPT)
Time Frame: From baseline to post 5-week intervention
|
Calf pressure pain threshold (PPT) will be assessed by placing marks on the medial condyle of the femur and the posterior of the medial malleolus.
The researcher will place the algometer on the muscle belly exactly halfway between the two marks.
Volunteers will be instructed to specify when the first onset of pain occurs as the researcher gradually applies pressure.
Quadricep measurements will involve the participant lying in the supine position where marks will be made on the anterior inferior iliac spine and the top of the patella so the researchers can once again find a point exactly halfway between these two locations to apply the algometer.
Participants will be instructed to verbally indicate to the researcher when the onset of pain occurs as pressure is applied.
|
From baseline to post 5-week intervention
|
|
Change in countermovement jump assessment (CMJ) performance recovery
Time Frame: From baseline to post 5-week intervention
|
The researchers will demonstrate and instruct volunteers to "Stand upright with their hands above their head.
When you are ready, bend your knees and stick your hips back while keeping your hands to your hips.
Jump as high as possible and land softly."
Participants will perform three CMJs separated by 60 seconds.
Jump height will be recorded in cm and the highest value will be recorded.
|
From baseline to post 5-week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mary Stenson, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 5, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
October 17, 2025
First Submitted That Met QC Criteria
October 17, 2025
First Posted (Actual)
October 22, 2025
Study Record Updates
Last Update Posted (Actual)
May 4, 2026
Last Update Submitted That Met QC Criteria
April 30, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- Probiotic Supplementation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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