Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06863415

Study on the Enhancement of Intestinal and Immune Functions Through Probiotic Intervention

Evaluate the effectiveness and safety of Bifidobacterium longum subsp. infantis BI45 as a food supplement compared to a placebo in improving intestinal and immune functions in healthy adults.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Healthy

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 probiotic or 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 in the concentration of antimicrobial peptides (LL-37 and calprotectin) in feces before and after intervention

    Time frame: Week 0 and Week 8

    Detected by Enzyme-Linked Immunosorbent Assay (ELISA).

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

A Study on the Safety and Effectiveness of Bifidobacterium Longum Subsp. infantisBI45 in Improving Intestinal and Immune Functions

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 7, 2025
Registry last updated
Mar 10, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.