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

March 6, 2025 updated by: Wecare Probiotics Co., Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 462000
        • Henan University of Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 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
  2. Willing to self-administer probiotic or placebo once a day 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 Internal organ failure (heart, liver or kidney failure, etc.)
  5. Have received radiation or chemotherapy in the past
  6. 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
  7. Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic Group
Intervention with Bifidobacterium longum subsp. infantis BI45 (30 billion CFU/ day, 3g) was administered daily for 8 weeks. Store in a cool, dry place.
Dietary supplement: Probiotic
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 Comparator: Placebo Group
Every day to give 3 g maltodextrin intervention for 8 weeks. Store in a cool and dry place.
Dietary supplement: Placebo
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Week 0 and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wecare Probiotics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2025

Primary Completion (Estimated)

October 10, 2025

Study Completion (Estimated)

December 25, 2025

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • WK20250305

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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