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NCT Number: NCT06873425

Research on the Improvement of Intestinal and Immune Functions by Probiotics

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.

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Key information

Conditions

Intestinal Health

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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
  • Willing to self-administer one of the 7 probiotics (BI45, BBi32, LS97, LB42, LF61, LH76, LR08)/placebo once a day 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

Dietary supplement: Probiotics. 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

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).

Primary outcomes

  1. Change of concentration of antimicrobial peptide LL-37

    Time frame: Week 0 and Week 8

    Detected by Enzyme-Linked Immunosorbent Assay (ELISA).

  2. Change in calcarein concentration

    Time frame: Week 0 and Week 8

    Detected by Enzyme-Linked Immunosorbent Assay (ELISA).

Study contacts

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

Xu Fei, Doctor

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 Safety and Effectiveness of Limosilactobacillus Fermentum LF61 in Improving Intestinal and Immune Functions

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2025
Registry last updated
Mar 12, 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.

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