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NCT Number: NCT06886724

Investigating the Efficacy of Probiotics in Enhancing Gastrointestinal and Immunological Health

Evaluate the effectiveness and safety of Ligilactobacillus salivarius LS97 as a food supplement compared to a placebo in improving intestinal and immune functions in healthy adults.

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Key information

Conditions

Intestinal and Lmmune Function Lmproved

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xu fei

Zhengzhou, Henan, 210095, China

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
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

Treatment and study plan

Probiotic

Dietary Supplement

The trial period of this study lasts for 2 months (8 weeks), during which each participant will have 3 visits (at month 0, month 1, and month 2).

Placebo

Dietary Supplement

The trial period of this study lasts for 2 months (8 weeks), during which each participant will have 3 visits (at month 0, month 1, and month 2).

Primary outcomes

Change in the composition of fecal microbiota before and after intervention.

Time frame: Week 0 and Week 8

Analyzed by 16S rRNA sequencing.

Study contacts

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

Fei Xu

CONTACT

[email protected]

13671979116 ext. 86

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

A Study on the Role of Ligilactobacillus Salivarius LS97 in Modulating Gut Microbiota and Immune System Function

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Mar 20, 2025
Registry last updated: Mar 20, 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.