Not yet recruiting NCT06863415
Study on the Enhancement of Intestinal and Immune Functions Through Probiotic Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study on the Safety and Effectiveness of Bifidobacterium Longum Subsp. infantisBI45 in Improving Intestinal and Immune Functions
Overview
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.
Interventions
- 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). - 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).
Primary outcome measures
- Change in the concentration of antimicrobial peptides (LL-37 and calprotectin) in feces before and after intervention [Time frame: Week 0 and Week 8]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Henan University of Technology — Zhengzhou
Publications
- Song S, Ding L, Yang S, Liu J, Wang Z, Qin Y, Qin X, Xu F, Zhou F. Assessing the Safety and Probiotic Potential of Bifidobacterium longum subsp. infantis BI45: A Comprehensive Study from Genomic Analysis to Randomized Controlled Clinical Trial in Healthy Adults. Probiotics Antimicrob Proteins. 2026 May 12. doi: 10.1007/s12602-026-11044-4. Online ahead of print. PMID 42118446
Identifiers
NCT: NCT06863415 · WK20250305