The Role of Probiotic LH76 in Human Gut Health

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorWecare Probiotics Co., Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Placebo groupPlacebo comparator 1 intervention
Group B: Probiotic groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes in Gut Microbiota Composition in Response to LH76 Supplementation

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.

Time frame
Week 0 and Week 8

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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