Evidence map›Paper›PMID 42528393›Full record

Trial reportMicrobial biotechnology2026

Effects of Bifidobacterium animalis Subsp. Lactis CP-9 on Gut Microbiota and Immune Functions in Healthy Infants.

Liujing Zhang, Xueke Song, Keming Zhang, Xiaoshuang Xu, Xinmei Guo, Wei Li, Xiaoling Zeng, Yingguang Xie, Liwei Nie, Li Zhao and 6 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Microbial biotechnology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Liujing ZhangDepartment of Clinical Nutrition, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.ORCID https://orcid.org/0009-0002-9825-8706
Xueke SongDepartment of Clinical Nutrition, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.ORCID https://orcid.org/0000-0002-4011-8463
Keming ZhangFirst Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.ORCID https://orcid.org/0009-0008-1448-2828
Xiaoshuang XuCentral Laboratory, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.ORCID https://orcid.org/0009-0006-3621-2496
Xinmei GuoResearch and Development Department, Jinqiao Biotech co., Ltd., Huaian, Jiangsu, China.ORCID https://orcid.org/0009-0008-9044-8920
Wei LiResearch and Development Department, Jinqiao Biotech co., Ltd., Huaian, Jiangsu, China.ORCID https://orcid.org/0009-0005-2428-2502
Xiaoling ZengResearch and Development Department, Jinqiao Biotech co., Ltd., Huaian, Jiangsu, China.ORCID https://orcid.org/0000-0002-7038-9571
Yingguang XieJining No. 1 People's Hospital, Jining, Shandong, China.
Liwei NieWomen and Children's Health Care Hospital of Linyi, Linyi, Shandong, China.ORCID https://orcid.org/0009-0000-4204-7710
Li ZhaoPanjin Liaohe Gemstone Flower Hospital, Panjin, Liaoning, China.ORCID https://orcid.org/0009-0000-0255-6916
Xuelu DaiDepartment of Clinical Nutrition, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.ORCID https://orcid.org/0009-0000-7469-0065
Jing SunDepartment of Clinical Nutrition, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.ORCID https://orcid.org/0009-0004-2342-601X
Jiai YanDepartment of Clinical Nutrition, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.ORCID https://orcid.org/0000-0003-1720-6278
Yiran LiuDepartment of Clinical Nutrition, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.ORCID https://orcid.org/0009-0003-7574-6253
Feng ZhangDepartment of Clinical Nutrition, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.ORCID https://orcid.org/0000-0002-1401-9728
Zhiping SunDepartment of Clinical Nutrition, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.ORCID https://orcid.org/0009-0000-0227-8717

Funding

National Natural Science Foundation of China 82370809the funding for Medical Key Strategic Project of Wuxi Health Commissionthe Innovation and Entrepreneurship Talent Program of Jiangsu Province, Enterprise Innovation Category JSSCRC2023500
6 · The paper itself

Abstract

Infancy represents a critical period for growth and development, during which the gut microbiota and its metabolites play essential roles in nutrient absorption and maintaining health. Therefore, it is of great significance to evaluate the safety and gut microbiota-modulating effects of specific probiotics in healthy infants. This study aimed to investigate the effect of Bifidobacterium animalis subsp. lactis CP-9 strain (CP-9) on healthy infants aged 6 to 36 months and its relationship with growth patterns and multidimensional indicators. In this randomized, double-blind, placebo-controlled trial, healthy infants were randomly assigned to receive CP-9 or placebo for 3 months. Safety, growth parameters, complete blood counts (CBC), immunological markers and faecal microbiota were assessed before and after the intervention. All infants exhibited age-appropriate growth in height and head circumference during the study. The CP-9 strain significantly increased gut Bifidobacterium abundance and regulated the microbiota-mediated polyunsaturated fatty acids biosynthesis pathway. Haematological and systemic inflammatory markers remained within normal ranges and no treatment-related adverse changes were detected during the 3-month intervention period. Moreover, CP-9 improved stool characteristics and gastrointestinal tolerability, with no increase in the incidence of respiratory allergies, skin allergies, respiratory infections, or fever, which further confirmed its safety. These findings suggested that CP-9 supplementation resulted in significant enrichment of Bifidobacterium, a beneficial gut bacterium and had no detectable adverse effects on the measured physiological parameters. Consequently, the intervention raised no detectable safety concerns in healthy infants under the conditions of this study. Given this, CP-9 is a probiotic that does not show any obvious short-term safety signals for infants aged 6 to 36 months.

Indexed as

Bifidobacterium animalisGastrointestinal MicrobiomeProbioticsChild, PreschoolDouble-Blind MethodFecesFemaleHumansInfantMaleBifidobacterium animalis subsp. lactis CP‐9gut microbiotainfantprobioticssafety

Identifiers

PMID42528393
PMCPMC13420211

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.