Investigating the Efficacy of Probiotics in Enhancing Gastrointestinal and Immunological Health

NCT ID: NCT06886724

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-10

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Intestinal and Lmmune Function Lmproved

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Probiotic group

Intervention with Ligilactobacillus salivarius LS97 (30 billion CFU/day, 3g) was administered daily for 8 weeks.

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type 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 group

Every day to give 3 g maltodextrin intervention for 8 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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).

Interventions

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Probiotic

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).

Intervention Type DIETARY_SUPPLEMENT

Placebo

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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xu fei

Zhengzhou, Henan, China

Site Status

Countries

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China

Central Contacts

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Fei Xu

Role: CONTACT

13671979116 ext. 86

Other Identifiers

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WK20250307

Identifier Type: -

Identifier Source: org_study_id

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