NCT07387991

Evaluating the Ability of a Multi-Strain Postbiotic to Impact Inflammation, Immune Components, Gastrointestinal Symptoms, Recovery, Anxiety, and Intestinal Permeability

Clinical Trial to Evaluate the Ability of Multi-Strain Postbiotic to Impact Inflammation, Immune Components, Gastrointestinal Symptoms, Recovery, Anxiety, and Intestinal Permeability

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Lindenwood University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Inflammation
• Gastrointestinal Symptoms

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Multi-Strain Postbiotic	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.
DIETARY_SUPPLEMENT	Placebo	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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2026-02-04
• Last updated: 2026-02-04

Locations

1 site across 1 country: United States