The Role of Probiotic LH76 in Human Gut Health

NCT06875375 | Not Yet Recruiting

• 1 other identifier: WK20250309
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

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.

  Week 0 and Week 8

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Probiotic group

EXPERIMENTAL

Dietary Supplement: probiotic LH76

Interventions

probiotic LH76 DIETARY_SUPPLEMENT

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

Probiotic group

Placebo DIETARY_SUPPLEMENT

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

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Central Study Contacts

Fei Xu, Dr.

CONTACT

13671979116; xu.fei@haut.edu.cn

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: May 11, 2025
• Primary Completion: May 20, 2025
• Study Completion: October 26, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03