Recruiting soon

Bifidobacterium Longum Subsp. infantis BI45 for Intestinal and Immune Health

What is being tested

Probiotic

+ Placebo

Dietary Supplement

Who is being recruted

From 18 to 45 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Placebo-Controlled

Interventional

Study Start: March 2025

See protocol details

Summary

Principal SponsorWecare Probiotics Co., Ltd.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 15, 2025

Actual date on which the first participant was enrolled.

This study is exploring whether a specific type of probiotic, called Bifidobacterium longum subsp. infantis BI45, can help improve gut and immune health in healthy adults. The goal is to see if taking this probiotic as a food supplement is better than taking a placebo, which is a substance with no active ingredients. Understanding how this probiotic affects the body could lead to better ways to maintain digestive health and strengthen the immune system, benefiting people who seek to enhance their overall well-being. Participants in the study will take either the probiotic supplement or a placebo. The method of taking the supplement is not specified, but it is typically ingested orally. The study will monitor changes in participants to see how their intestinal and immune functions respond over time. No specific risks or side effects are mentioned, indicating a focus on observing the general effects of the supplement on healthy individuals.

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

NCT06863415

Principal SponsorWecare Probiotics Co., Ltd.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

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

7 exclusion criteria prevent from participating

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.)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Intervention with Bifidobacterium longum subsp. infantis BI45 (30 billion CFU/ day, 3g) was administered daily for 8 weeks. Store in a cool, dry place.

Group II

Placebo

Every day to give 3 g maltodextrin intervention for 8 weeks. Store in a cool and dry place.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Henan University of Technology

Zhengzhou, ChinaOpen Henan University of Technology in Google Maps

Recruiting soonOne Study Center