The Role of Probiotic LH76 in Human Gut Health

NCT ID: NCT06875375

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-11
• Study Completion Date: 2025-10-26

Brief Summary

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.

Conditions

Gut Microbiota Modulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Probiotic group

Group Type: EXPERIMENTAL

probiotic LH76

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

probiotic LH76

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. 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

2. Willing to self-administer probiotic or placebo once a day during the intervention period

3. Good eyesight, can read and write, can wear glasses

4. Have good hearing and be able to hear and understand all instructions during the intervention

Exclusion Criteria

1. Digestive diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease)

2. 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)

3. Have received/are receiving treatment for the following mental disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder

4. Take medication for depression or low mood Internal organ failure (heart, liver or kidney failure, etc.)

5. Have received radiation or chemotherapy in the past

6. 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

7. Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past Open Contacts/Locations

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Fei Xu, Dr.

Role: CONTACT

xu.fei@haut.edu.cn

13671979116

Other Identifiers

WK20250309

Identifier Type: -

Identifier Source: org_study_id