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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Group | 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. |
|
| Placebo Group | Placebo Comparator | Every day to give 3 g maltodextrin intervention for 8 weeks. Store in a cool and dry place. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the concentration of antimicrobial peptides (LL-37 and calprotectin) in feces before and after intervention | Detected by Enzyme-Linked Immunosorbent Assay (ELISA). | Week 0 and Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan University of Technology | Zhengzhou | Henan | 462000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42118446 | Derived | 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. |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| 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). |
|
| D019602 |
| Food and Beverages |