Investigating the Efficacy of Probiotics in Enhancing Gastrointestinal and Immunological Health

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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06886724

Enrollment

Registered

2025-03-20

Start date

2025-03-10

Completion date

2025-12-30

Last updated

2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal and Lmmune Function Lmproved

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTProbiotic

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).

DIETARY_SUPPLEMENTPlacebo

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1. Willing to undergo 3 follow-up visits during the intervention period 2. Be willing to provide blood, urine and stool samples 2 times 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 5. Internal organ failure (heart, liver or kidney failure, etc.) 6. Have received radiation or chemotherapy in the past 7. 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 8. Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past

Design outcomes

Primary

Measure	Time frame	Description
Change in the composition of fecal microbiota before and after intervention.	Week 0 and Week 8	Analyzed by 16S rRNA sequencing.

Countries

China

Contacts

Primary ContactFei Xu

xu.fei@haut.edu.cn13671979116

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026