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Completed

NCT Number: NCT06875362

Probiotic LR08 Improves Gut and Metabolism

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.

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Key information

Conditions

Healthy Adults

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xu fei

Zhengzhou, Henan, 210095, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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).

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).

Primary outcomes

  1. Changes in Immune Function

    Time frame: Week 0 and Week 8

    Evaluation of immune function markers, specifically immunoglobulin A (IgA) concentration, to assess the effects of LR08 supplementation compared to placebo.

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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