Probiotic LR08 Improves Gut and Metabolism

Safety and Efficacy of LR08 in Modulating Gut Microbiota and Improving Metabolic Health in Healthy Adults: A Clinical Study

Evaluate the efficacy and safety of LR08 as a dietary supplement compared to a placebo in enhancing intestinal health and immune function in healthy adults.

Study Overview

• Status: Completed
• Conditions: Healthy Adults
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 210095
      • Xu fei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Willing to attend 3 follow-up visits during the intervention period
2. Agree to provide blood, urine, and stool samples twice during the intervention period
3. Good eyesight, able to read and write, and capable of wearing glasses if needed
4. Good hearing and able to fully comprehend all instructions during the intervention

Exclusion Criteria:

1. Presence of digestive diseases, particularly gastrointestinal disorders (e.g., celiac disease, ulcerative colitis, Crohn's disease)
2. History of serious neurological conditions (e.g., epilepsy, stroke, severe head trauma, meningitis within the last 10 years, brain surgery, brain tumor, or prolonged coma-not including general anesthesia)
3. History of or currently receiving treatment for mental health disorders such as alcohol/drug/substance abuse, schizophrenia, psychosis, or bipolar disorder
4. Currently taking medication for depression or low mood
5. Presence of internal organ failure (e.g., heart, liver, or kidney failure)
6. History of radiation therapy or chemotherapy treatments
7. Underwent general anesthesia within the past three years or are scheduled for general anesthesia within the next 3 months during the trial period
8. History of hepatitis (B or C), HIV, or syphilis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; Every day to give 3 g maltodextrin intervention for 8 weeks.	Dietary supplement: Placebo; The trial period of this study lasts for 2 months(8weeks), during which each participant will have 3 visits (at month 0, month 1, andmonth 2).
Active Comparator: Probiotic group; Intervention with probiotic LR08 (30 billion CFU/day, 3g) was administered daily for 8 weeks.	Dietary supplement: Probiotic; The trial period of this study lasts for 2 months(8weeks), during which each participant will have 3 visits (at month 0, month 1, andmonth 2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Immune Function	Evaluation of immune function markers, specifically immunoglobulin A (IgA) concentration, to assess the effects of LR08 supplementation compared to placebo.	Week 0 and Week 8

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: March 8, 2025
• First Submitted That Met QC Criteria: March 8, 2025
• First Posted (Actual): March 13, 2025

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Probiotics; Gut Microbiota; Immune Function
• Other Study ID Numbers: WK20250308

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No