Research on the Improvement of Intestinal and Immune Functions by Probiotics

Not Applicable

Not yet recruiting

• Conditions: Intestinal Health

• Registration Number: NCT06873425
• Lead Sponsor: Wecare Probiotics Co., Ltd.

Brief Summary

Evaluate the effectiveness and safety of Limosilactobacillus fermentum LF61 as a food supplement compared to a placebo in improving intestinal and immune functions in healthy adults.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study Start: 2025-03-10
• Study First Posted: 2025-03-12
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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. Willing to self-administer one of the 7 probiotics (BI45, BBi32, LS97, LB42, LF61, LH76, LR08)/placebo once a day during the intervention period
4. Good eyesight, can read and write, can wear glasses
5. 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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of concentration of antimicrobial peptide LL-37	Week 0 and Week 8	Detected by Enzyme-Linked Immunosorbent Assay (ELISA).
Change in calcarein concentration	Week 0 and Week 8	Detected by Enzyme-Linked Immunosorbent Assay (ELISA).

Trial Locations

Locations (1)

Xu fei; 🇨🇳 Zhengzhou, Henan, China