The Role of Probiotic LH76 in Human Gut Health

This study aims to evaluate the safety and efficacy of the probiotic LH76 as a dietary supplement in healthy adults. The research will assess its effects on gut microbiota composition, intestinal health, and immune function compared to a placebo. Key outcomes include changes in microbial diversity, intestinal barrier integrity, and immune response markers over the intervention period. The findings will contribute to understanding the potential health benefits of LH76 and its role in supporting gut and immune health.

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Key information

Conditions

Gut Microbiota Modulation

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Willing to undergo 3 follow-up visits during the intervention period Be willing to provide blood, urine and stool samples 2 times during the intervention period
Willing to self-administer probiotic or placebo once a day during the intervention period
Good eyesight, can read and write, can wear glasses
Have good hearing and be able to hear and understand all instructions during the intervention

Exclusion criteria

Digestive diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease)
Have a serious neurological condition (epilepsy, stroke, severe head trauma, meningitis in the last 10 years, brain surgery, brain tumor, prolonged coma - not including general anaesthesia)
Have received/are receiving treatment for the following mental disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder
Take medication for depression or low mood Internal organ failure (heart, liver or kidney failure, etc.)
Have received radiation or chemotherapy in the past
Have undergone a general anesthesia procedure/procedure within the past three years, or plan to undergo a general anesthesia procedure/procedure within the next 3 months during this trial period
Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past Open Contacts/Locations

Treatment and study plan

probiotic LH76

Dietary Supplement

Intervention with LH76 (30 billion CFU/ day, 3g) was administered daily for 8 weeks. Store in a cool, dry place.

Placebo

Dietary Supplement

Every day to give 3 g maltodextrin intervention for 8 weeks. Store in a cool and dry place.

Primary outcomes

Changes in Gut Microbiota Composition in Response to LH76 Supplementation

Time frame: Week 0 and Week 8

This study assesses the impact of LH76 supplementation on gut microbiota diversity and composition using high-throughput sequencing. The primary objective is to determine whether LH76 supplementation leads to significant improvements in gut microbiota balance compared to a placebo. Changes in microbial diversity, relative abundance of beneficial bacteria will be analyzed to assess the probiotic's effectiveness.

Study contacts

Contact information is provided by the study sponsor or research team.

Fei Xu, Dr.

CONTACT

[email protected]

13671979116

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

A Clinical Study on the Safety and Efficacy of Probiotic LH76 in Modulating Gut Microbiota and Enhancing Intestinal Health in Healthy Adults

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Mar 13, 2025
Registry last updated: Mar 18, 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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