Multi-Strain Postbiotic for Inflammation and Gastrointestinal Symptoms

(BIO Trial)

AM
JM
Overseen ByJoesi M Krieger, MS

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a multi-strain postbiotic supplement can improve the body's response to stress and exercise. Researchers aim to determine if taking the supplement for four weeks affects inflammation, immune response, gut health, and mental well-being after exercise. Participants will take either the postbiotic or a placebo (a harmless pill with no active ingredient) and then perform a treadmill workout to assess the effects. The study seeks healthy adults who exercise regularly and can complete a treadmill workout without issues. As an unphased trial, it offers participants the chance to contribute to groundbreaking research on postbiotics and their potential health benefits.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription medications, especially antibiotics and anti-inflammatories, for at least two months before joining the study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that multi-strain postbiotic supplements are generally safe for people. In one study, participants who took both low and high doses of a multi-strain postbiotic reported no negative side effects, suggesting the supplement is well-tolerated. Another study found that similar multi-strain probiotics were safe and even improved symptoms in people with digestive issues like IBD and IBS. This evidence can reassure those considering joining a trial, as it indicates the supplement is safe and may benefit gut health.12345

Why are researchers excited about this trial?

Most treatments for inflammation and gastrointestinal symptoms focus on reducing inflammation or soothing the gut lining. But this new multi-strain postbiotic stands out because it harnesses beneficial byproducts of probiotics, called postbiotics, to potentially improve gut health and reduce inflammation. Unlike traditional options that rely on live bacteria or chemical agents, this postbiotic delivers its benefits through non-living bacterial byproducts, which can be more stable and easier to tolerate. Researchers are excited about this treatment because it might offer a new way to support gut health with fewer side effects and a more convenient daily regimen.

What evidence suggests that this multi-strain postbiotic is effective for inflammation and gastrointestinal symptoms?

Studies have shown that multi-strain postbiotics can greatly improve stomach issues like indigestion, belly pain, and heartburn in just four weeks. Research also shows that postbiotics can lower signs of inflammation and boost the immune system. In some cases, up to 45% of participants experienced major relief from symptoms compared to those who did not take the supplements. This trial will compare a multi-strain postbiotic supplement with a placebo to evaluate its effectiveness in reducing inflammation and stomach problems, presenting a promising option for better gut health and overall well-being.15678

Who Is on the Research Team?

CM

Chad M Kerksick, PhD

Principal Investigator

Lindenwood University

Are You a Good Fit for This Trial?

Healthy adults aged 18 to 55 who can perform moderate-to-high intensity exercise are eligible for this trial. Participants must not have any health conditions that could affect the study's results or their ability to complete it.

Inclusion Criteria

Subject has the ability to exercise on a treadmill without issue or concern
I can follow the study plan and attend all appointments, even if they take up to 4 hours.
Subject is a non-smoker
See 8 more

Exclusion Criteria

Clinically significant abnormal laboratory results at screening
Allergy or sensitivity to study supplement ingredients
I haven't taken supplements, prescription drugs, or probiotics in the last 2 months.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a multi-strain postbiotic supplement or a placebo for 28 days

4 weeks
1 visit (in-person) at the start, self-administration daily

Exercise Challenge

Participants complete a 45-minute treadmill exercise bout at 75% of their maximum heart rate

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week
1 visit (in-person) for follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

  • Multi-Strain Postbiotic

Trial Overview

The trial is testing if a multi-strain postbiotic supplement can change how the body and mind respond to stress from exercise compared to a placebo. It involves taking the supplement for four weeks, then doing an exercise test.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: PostbioticExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lindenwood University

Lead Sponsor

Trials
22
Recruited
830+

Citations

Evaluating the Ability of a Multi-Strain Postbiotic to Impact ...

This study will evaluate the effects of a multi-strain postbiotic supplement on markers of inflammation, immune function, gastrointestinal ...

High-potency multi-strain probiotic formulations for safety and ...

After 4 weeks, both Wec600B and Wec1000B groups demonstrated significant improvement in gastrointestinal symptoms, including indigestion, abdominal pain, reflux ...

Multi-Strain Probiotic Well Tolerated by Patients With IBD ...

The analysis demonstrated that 45% of patients receiving the probiotic achieved a 100-point reduction in the IBS-SSS compared with 33% of those ...

Effects of Two Compound Probiotic Formulations on ...

In summary, both compound probiotic formulations effectively alleviated GI symptoms in the short term, improved inflammatory (FC, NGAL) and immune (IgA, FL) ...

The Effectiveness and Safety of Multi-Strain Probiotic ... - PMC

In conclusion, the multi-strain probiotic intervention resulted in a significant improvement in IBS symptoms evaluated with the use of both IBS-SSS and IBS-GIS ...

Evaluating the Ability of a Multi-Strain Postbiotic to Impact ...

This study will evaluate the effects of a multi-strain postbiotic supplement on markers of inflammation, immune function, gastrointestinal ...

Safety and Effect of a Low- and High-Dose Multi-Strain ...

Participants' gastrointestinal and general wellbeing were unaffected. No adverse events were associated with either dose. Supplemented strains ...

High-Potency Multi-Strain Probiotic Formulations for Safety ...

Safety outcomes, gastrointestinal symptom improvement rate, immune and inflammatory biomarkers, intestinal barrier function, and gut microbiota diversity ...