InflammationBIONCT07387991
Evaluating the Ability of a Multi-Strain Postbiotic to Impact Inflammation, Immune Components, Gastrointestinal Symptoms, Recovery, Anxiety, and Intestinal Permeability
A study testing Multi-Strain Postbiotic in people with Inflammation and Gastrointestinal Symptoms, run by Lindenwood University at 1 site in United States.
Trial summary
This study will evaluate the effects of a multi-strain postbiotic supplement on markers of inflammation, immune function, gastrointestinal symptoms, psychological well-being, and intestinal permeability in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Gastrointestinal Symptoms
- What is being tested?
- Multi-Strain Postbiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females aged 18 to 55 years of age. Individual indicates they are physically active defined as: 30 minutes of moderate intensity activity 4 days per week in the past 3 months.
- Subject has the ability to exercise on a treadmill without issue or concern. Body Mass Index (BMI) 18.0-32.0 kg/m2 (normal weight to obesity weight). The average BMI of the entire cohort will be <30.0 kg/m2.
- Subject is in good health and appropriate for exercise as determined by physical examination and medical history.
- Subject can exercise on a treadmill without issue or concern. Subject is a non-smoker. Subject agrees to not use any new vitamin, mineral, or dietary supplements 24 hours prior to the exercise test visits.
- Subject is willing and able to comply with the protocol including: attending the study scheduled appointments, of which two of the study visits may take up to four hours of completion.
- Subject agrees to refrain from exercise for the 24 hours prior to any test visits.
- Subject agrees to refrain from alcohol use for at least 24 hours before every study visit.
- Subject is able to understand and sign the informed consent to participate in the study.
Who cannot join
- Individuals who are determined to have liver, renal, cardiovascular, or other metabolic disease.
- Use of any dietary supplements, prescription mediation (particularly antibiotics and/or anti-inflammatories), or probiotics within the past 2 months which may confound the study or its endpoints.
- Alcohol consumption (>2 standard alcoholic drinks/day or >10 drinks/week) or drug abuse/dependence.
- Smokers (defined as greater than 2 cigarettes per day for past 90 days). Clinically significant abnormal laboratory results at screening. Allergy or sensitivity to study supplement ingredients. Individuals who are cognitively impaired and/or who are unable to give informed consent.
- Individuals with diabetes, asthma, rheumatoid arthritis, colitis, IBS/IBD, gout, or fibromyalgia.
- Any other condition which in the PI's opinion may adversely affect the subject's ability to complete the study, its measurement or poses significant risk to the subject.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Exercise and Performance Nutrition Laboratory
Saint Charles, Missouri, 63301
Anthony M Hagele, MS, 6369494785, ahagele@lindenwood.edu
Joesi M Krieger, MS, 6369494785, jmorey@lindenwood.edu
About this study
Official title: Clinical Trial to Evaluate the Ability of Multi-Strain Postbiotic to Impact Inflammation, Immune Components, Gastrointestinal Symptoms, Recovery, Anxiety, and Intestinal Permeability
This study will evaluate the effects of a multi-strain postbiotic supplement on markers of inflammation, immune function, gastrointestinal symptoms, psychological well-being, and intestinal permeability in healthy adults. The primary objective is to determine whether four weeks of postbiotic supplementation alters physiological and perceptual responses to a standardized bout of moderate-to-high intensity exercise compared with placebo.
Approximately 50 healthy men and women aged 18 to 55 years will be enrolled in a randomized, double-blind, placebo-controlled, parallel-group clinical trial. Participants will be randomly assigned to receive either a multi-strain postbiotic supplement or a matched placebo for 28 days.
Read more
At the end of the supplementation period, participants will complete a 45-minute treadmill exercise bout at 75% of their individually determined maximum heart rate. Blood samples will be collected to assess biomarkers of inflammation, immune activity, and recovery. Gastrointestinal symptoms, intestinal permeability, anxiety, and perceived recovery will be evaluated using validated questionnaires.
This study is designed to determine whether postbiotic supplementation modulates physiological stress responses and subjective well-being following prolonged exercise in healthy adults.
Read the detailed description
This study is designed to evaluate the effects of a multi-strain postbiotic supplement on physiological, gastrointestinal, and psychological responses to a standardized bout of aerobic exercise in healthy adults. Prolonged moderate-to-high intensity exercise is known to acutely increase inflammatory activity, alter immune function, disrupt gastrointestinal integrity, and influence perceptions of recovery and anxiety. Nutritional interventions that can modulate these responses may be beneficial for supporting health and resilience in physically active populations. Postbiotics, which consist of non-viable microbial cells and their metabolic byproducts, have been proposed to influence immune and gastrointestinal function while avoiding some of the stability and safety concerns associated with live probiotics.
Approximately 50 healthy men and women aged 18 to 55 years will be recruited to participate in a randomized, double-blind, placebo-controlled, parallel-group clinical trial. Eligible participants will be randomly assigned to receive either a multi-strain postbiotic supplement or a matched placebo for 28 consecutive days. Both participants and investigators will remain blinded to treatment assignment for the duration of the study.
Participants will be instructed to maintain their habitual diet, physical activity, and lifestyle behaviors throughout the supplementation period and to avoid the use of additional probiotic, prebiotic, or immune-modulating supplements. Compliance with supplementation will be monitored by self-report and capsule counts.
At the end of the 28-day supplementation period, participants will complete a standardized 45-minute treadmill exercise bout performed at 75% of their individually determined maximum heart rate. This exercise protocol is designed to induce a controlled physiological stress that elicits measurable inflammatory, immune, and gastrointestinal responses.
Blood samples will be collected to assess biomarkers related to inflammation, immune function, and recovery. Gastrointestinal symptoms, intestinal permeability, anxiety, and perceived recovery will be assessed using validated questionnaires administered before and after the exercise challenge.
Safety will be monitored throughout the study through the collection of self-reported adverse events and investigator assessment.
This study will determine whether supplementation with a multi-strain postbiotic alters physiological and perceptual responses to prolonged aerobic exercise compared with placebo in healthy adults.
- Conditions
- Inflammation, Gastrointestinal Symptoms
- Being tested
- Multi-Strain Postbiotic, Placebo
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Strain PostbioticDietary supplement
Participants will ingest a multi-strain postbiotic supplement once daily for 28 days. Each dose will be consumed with approximately eight ounces of water at the same time each day. If a dose is missed, participants will be instructed to take the missed dose the following day by splitting the dose into one capsule in the morning and one capsule in the evening.
PlaceboDietary supplement
Participants will ingest a placebo consisting of microcrystalline cellulose in capsule form once daily for 28 days. The placebo capsules will be identical in size, color, and appearance to the active supplement and will be consumed with approximately eight ounces of water at the same time each day. If a dose is missed, participants will be instructed to take the missed dose the following day by splitting the dose into one capsule in the morning and one capsule in the evening.
| Study group | Role | What they receive |
|---|---|---|
| Postbiotic | Experimental | Participants assigned to the postbiotic group will consume a multi-strain postbiotic supplement daily for 28 consecutive days prior to completing a standardized treadmill exercise bout. The supplement will be provided in capsule form and consumed once daily with approximately eight ounces of water. Receives: Dietary Supplement: Multi-Strain Postbiotic |
| Placebo | Placebo comparator | Participants assigned to the placebo group will consume a placebo consisting of microcrystalline cellulose in capsule form daily for 28 consecutive days prior to completing a standardized treadmill exercise bout. The placebo capsules will be identical in size, color, and appearance to the postbiotic capsules and will be consumed once daily with approximately eight ounces of water. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-6 (IL-6)
Baseline, pre-exercise, immediately post-exercise, 1-hour post-exercise, 3-hours post-exercise, and 24-hours post-exercise after 28 days of supplementation
Measured: Serum IL-6 concentrations will be measured using multiplex bead-based assays to assess the inflammatory response to a standardized 45-minute treadmill exercise bout following 28 days of supplementation.
Tumor Necrosis Factor-α (TNF-α)
Baseline, pre-exercise, immediately post-exercise, 1-hour post-exercise, 3-hours post-exercise, and 24-hours post-exercise after 28 days of supplementation
Measured: Serum TNF-α concentrations will be measured using multiplex bead-based assays to assess exercise-induced inflammatory responses following supplementation.
Interleukin-10 (IL-10)
Baseline, pre-exercise, immediately post-exercise, 1-hour post-exercise, 3-hours post-exercise, and 24-hours post-exercise after 28 days of supplementation
Measured: Serum IL-10 concentrations will be measured to assess anti-inflammatory and immune regulatory responses to exercise following supplementation.
Perceived Recovery Scale (PRS)
Subjective recovery will be assessed using the Perceived Recovery Scale (PRS), a 0-10 scale reflecting perceived readiness and recovery status.
Measured: Baseline, pre-exercise, immediately post-exercise, 1-hour post-exercise, 3-hours post-exercise, and 24-hours post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a randomized, double-blind, placebo-controlled, parallel-group design. Eligible participants will be randomly assigned to receive either a multi-strain postbiotic supplement or a matched placebo for 28 consecutive days. Randomization will be stratified by sex and age. Participants will remain in their assigned intervention group for the duration of the study. At the end of the supplementation period, all participants will complete a standardized 45-minute treadmill exercise bout at 72 to 78% of predicted maximum heart rate to induce a controlled physiological stress. Biological, gastrointestinal, and psychological responses will be assessed before and after the exercise bout to compare responses between the postbiotic and placebo groups.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lindenwood University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad M Kerksick, PhD, Principal investigator, Lindenwood University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387991
- Sponsor's protocol ID
- IRB-26-17
- Acronym
- BIO
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data contain sensitive longitudinal biological and symptom information that cannot be reliably de-identified without compromising participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Ability of Multi-Strain Postbiotic to Impact Inflammation, Immune Components, Gastrointestinal Symptoms, Recovery, Anxiety, and Intestinal Permeability
- ClinicalTrials.gov ID
- NCT07387991
- Acronym / sponsor ID
- BIO / IRB-26-17
- Conditions
- Inflammation, Gastrointestinal Symptoms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lindenwood UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effects of a multi-strain postbiotic supplement on markers of inflammation, immune function, gastrointestinal symptoms, psychological well-being, and intestinal permeability in healthy adults. The primary objective is to determine whether four weeks of postbiotic supplementation alters physiological and perceptual responses to a standardized bout of moderate-to-high intensity exercise compared with placebo.
Approximately 50 healthy men and women aged 18 to 55 years will be enrolled in a randomized, double-blind, placebo-controlled, parallel-group clinical trial. Participants will be randomly assigned to receive either a multi-strain postbiotic supplement or a matched placebo for 28 days.
At the end of the supplementation period, participants will complete a 45-minute treadmill exercise bout at 75% of their individually determined maximum heart rate. Blood samples will be collected to assess biomarkers of inflammation, immune activity, and recovery. Gastrointestinal symptoms, intestinal permeability, anxiety, and perceived recovery will be evaluated using validated questionnaires.
This study is designed to determine whether postbiotic supplementation modulates physiological stress responses and subjective well-being following prolonged exercise in healthy adults.
Detailed description
This study is designed to evaluate the effects of a multi-strain postbiotic supplement on physiological, gastrointestinal, and psychological responses to a standardized bout of aerobic exercise in healthy adults. Prolonged moderate-to-high intensity exercise is known to acutely increase inflammatory activity, alter immune function, disrupt gastrointestinal integrity, and influence perceptions of recovery and anxiety. Nutritional interventions that can modulate these responses may be beneficial for supporting health and resilience in physically active populations. Postbiotics, which consist of non-viable microbial cells and their metabolic byproducts, have been proposed to influence immune and gastrointestinal function while avoiding some of the stability and safety concerns associated with live probiotics.
Approximately 50 healthy men and women aged 18 to 55 years will be recruited to participate in a randomized, double-blind, placebo-controlled, parallel-group clinical trial. Eligible participants will be randomly assigned to receive either a multi-strain postbiotic supplement or a matched placebo for 28 consecutive days. Both participants and investigators will remain blinded to treatment assignment for the duration of the study.
Participants will be instructed to maintain their habitual diet, physical activity, and lifestyle behaviors throughout the supplementation period and to avoid the use of additional probiotic, prebiotic, or immune-modulating supplements. Compliance with supplementation will be monitored by self-report and capsule counts.
At the end of the 28-day supplementation period, participants will complete a standardized 45-minute treadmill exercise bout performed at 75% of their individually determined maximum heart rate. This exercise protocol is designed to induce a controlled physiological stress that elicits measurable inflammatory, immune, and gastrointestinal responses.
Blood samples will be collected to assess biomarkers related to inflammation, immune function, and recovery. Gastrointestinal symptoms, intestinal permeability, anxiety, and perceived recovery will be assessed using validated questionnaires administered before and after the exercise challenge.
Safety will be monitored throughout the study through the collection of self-reported adverse events and investigator assessment.
This study will determine whether supplementation with a multi-strain postbiotic alters physiological and perceptual responses to prolonged aerobic exercise compared with placebo in healthy adults.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study uses a randomized, double-blind, placebo-controlled, parallel-group design. Eligible participants will be randomly assigned to receive either a multi-strain postbiotic supplement or a matched placebo for 28 consecutive days. Randomization will be stratified by sex and age. Participants will remain in their assigned intervention group for the duration of the study. At the end of the supplementation period, all participants will complete a standardized 45-minute treadmill exercise bout at 72 to 78% of predicted maximum heart rate to induce a controlled physiological stress. Biological, gastrointestinal, and psychological responses will be assessed before and after the exercise bout to compare responses between the postbiotic and placebo groups.
| Arm | Type | Receives |
|---|---|---|
| Postbiotic | Experimental | Dietary Supplement: Multi-Strain PostbioticParticipants assigned to the postbiotic group will consume a multi-strain postbiotic supplement daily for 28 consecutive days prior to completing a standardized treadmill exercise bout. The supplement will be provided in capsule form and consumed once daily with approximately eight ounces of water. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants assigned to the placebo group will consume a placebo consisting of microcrystalline cellulose in capsule form daily for 28 consecutive days prior to completing a standardized treadmill exercise bout. The placebo capsules will be identical in size, color, and appearance to the postbiotic capsules and will be consumed once daily with approximately eight ounces of water. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy males and females aged 18 to 55 years of age. Individual indicates they are physically active defined as: 30 minutes of moderate intensity activity 4 days per week in the past 3 months.
- Subject has the ability to exercise on a treadmill without issue or concern. Body Mass Index (BMI) 18.0-32.0 kg/m2 (normal weight to obesity weight). The average BMI of the entire cohort will be <30.0 kg/m2.
- Subject is in good health and appropriate for exercise as determined by physical examination and medical history.
- Subject can exercise on a treadmill without issue or concern. Subject is a non-smoker. Subject agrees to not use any new vitamin, mineral, or dietary supplements 24 hours prior to the exercise test visits.
- Subject is willing and able to comply with the protocol including: attending the study scheduled appointments, of which two of the study visits may take up to four hours of completion.
Key exclusion criteria (6 listed)
- Individuals who are determined to have liver, renal, cardiovascular, or other metabolic disease.
- Use of any dietary supplements, prescription mediation (particularly antibiotics and/or anti-inflammatories), or probiotics within the past 2 months which may confound the study or its endpoints.
- Alcohol consumption (>2 standard alcoholic drinks/day or >10 drinks/week) or drug abuse/dependence.
- Smokers (defined as greater than 2 cigarettes per day for past 90 days). Clinically significant abnormal laboratory results at screening. Allergy or sensitivity to study supplement ingredients. Individuals who are cognitively impaired and/or who are unable to give informed consent.
- Individuals with diabetes, asthma, rheumatoid arthritis, colitis, IBS/IBD, gout, or fibromyalgia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Strain PostbioticParticipants will ingest a multi-strain postbiotic supplement once daily for 28 days. Each dose will be consumed with approximately eight ounces of water at the same time each day. If a dose is missed, participants will be instructed to take the missed dose the following day by splitting the dose into one capsule in the morning and one capsule in the evening. | Dietary supplement | Postbiotic |
| PlaceboParticipants will ingest a placebo consisting of microcrystalline cellulose in capsule form once daily for 28 days. The placebo capsules will be identical in size, color, and appearance to the active supplement and will be consumed with approximately eight ounces of water at the same time each day. If a dose is missed, participants will be instructed to take the missed dose the following day by splitting the dose into one capsule in the morning and one capsule in the evening. | Dietary supplement | Placebo |
Primary outcome
Interleukin-6 (IL-6)
Time frame: Serum IL-6 concentrations will be measured using multiplex bead-based assays to assess the inflammatory response to a standardized 45-minute treadmill exercise bout following 28 days of supplementation.
Baseline, pre-exercise, immediately post-exercise, 1-hour post-exercise, 3-hours post-exercise, and 24-hours post-exercise after 28 days of supplementation
Tumor Necrosis Factor-α (TNF-α)
Time frame: Serum TNF-α concentrations will be measured using multiplex bead-based assays to assess exercise-induced inflammatory responses following supplementation.
Baseline, pre-exercise, immediately post-exercise, 1-hour post-exercise, 3-hours post-exercise, and 24-hours post-exercise after 28 days of supplementation
Interleukin-10 (IL-10)
Time frame: Serum IL-10 concentrations will be measured to assess anti-inflammatory and immune regulatory responses to exercise following supplementation.
Baseline, pre-exercise, immediately post-exercise, 1-hour post-exercise, 3-hours post-exercise, and 24-hours post-exercise after 28 days of supplementation
Perceived Recovery Scale (PRS)
Time frame: Baseline, pre-exercise, immediately post-exercise, 1-hour post-exercise, 3-hours post-exercise, and 24-hours post-exercise
Subjective recovery will be assessed using the Perceived Recovery Scale (PRS), a 0-10 scale reflecting perceived readiness and recovery status.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No. Data contain sensitive longitudinal biological and symptom information that cannot be reliably de-identified without compromising participant privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chad M Kerksick, PhD principal investigator
Lindenwood University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Strain Postbiotic in people with Inflammation and Gastrointestinal Symptoms, run by Lindenwood University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony M Hagele, MS (6369494785, ahagele@lindenwood.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-6 (IL-6) (time frame: Serum IL-6 concentrations will be measured using multiplex bead-based assays to assess the inflammatory response to a standardized 45-minute treadmill exercise bout following 28 days of supplementation.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.