Probiotic LR08 Improves Gut and Metabolism

NCT06875362 | Completed

• 1 other identifier: WK20250308
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Adults

Keywords

Probiotics; Efficacy; Safety; Gut Microbiota; Immune Function

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Probiotic group

ACTIVE COMPARATOR

Intervention with probiotic LR08 (30 billion CFU/day, 3g) was administered daily for 8 weeks.

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

Every day to give 3 g maltodextrin intervention for 8 weeks.

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

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).

Probiotic group

Placebo DIETARY_SUPPLEMENT

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).

Placebo group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Presence of digestive diseases, particularly gastrointestinal disorders (e.g., celiac disease, ulcerative colitis, Crohn's disease)
• 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)
• History of or currently receiving treatment for mental health disorders such as alcohol/drug/substance abuse, schizophrenia, psychosis, or bipolar disorder
• Currently taking medication for depression or low mood
• Presence of internal organ failure (e.g., heart, liver, or kidney failure)
• History of radiation therapy or chemotherapy treatments
• Underwent general anesthesia within the past three years or are scheduled for general anesthesia within the next 3 months during the trial period
• History of hepatitis (B or C), HIV, or syphilis

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Xu fei

Zhengzhou, Henan, 210095, China

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: March 13, 2025
• Study Start: March 10, 2025
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-03

Locations

CN (1)