The Role of Probiotic LH76 in Human Gut Health

March 13, 2025 updated by: Wecare Probiotics Co., Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
Dietary supplement: Placebo
Every day to give 3 g maltodextrin intervention for 8 weeks. Store in a cool and dry place.
Experimental: Probiotic group
Dietary supplement: probiotic LH76
Intervention with LH76 (30 billion CFU/ day, 3g) was administered daily for 8 weeks. Store in a cool, dry place.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 0 and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wecare Probiotics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 11, 2025

Primary Completion (Estimated)

May 20, 2025

Study Completion (Estimated)

October 26, 2025

Study Registration Dates

First Submitted

March 8, 2025

First Submitted That Met QC Criteria

March 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • WK20250309

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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