Probiotic supplement in healthy infants to study gut microbiota and immune function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study tests the effects of Lacticaseibacillus paracasei LPB27 on gut microbiota composition, growth, and immune-related outcomes in healthy full-term infants aged 0-6 months. The study also looks at defecation patterns and common gastrointestinal symptoms. Participants will receive the probiotic supplement with maltodextrin, with restrictions on other probiotic use during the study. The trial is conducted at Zhongshan Hospital affiliated with Dalian University, sponsored by BYHEALTH Co., Ltd, with no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Infants born at full term and aged 0-6 months, whose overall health condition was determined to be good by the researchers;
* 2\. There are no restrictions on the mode of delivery and feeding methods;
* 3\. Agree not to consume probiotics other than the tested product or formula milk powder containing probiotics during the study period;
* 4\. Parents or legal guardians voluntarily participate in this clinical trial and sign the informed consent form.

Exclusion Criteria:

* 1\. Suffering from severe acute or chronic coexisting diseases (cardiovascular, gastrointestinal, metabolic, endocrine, immune or any disease deemed contraindicated by the researchers);
* 2\. Having a disease that might interfere with the researcher's observation of the normal development process of the infant's intestinal microecology. Such diseases include: acute infections (acute upper respiratory tract infection, acute diarrhea, etc.); autoimmune diseases (such as ulcerative colitis, Crohn's disease, etc.); intestinal surgeries (intussusception, intestinal obstruction, endoscopic examination, etc.), major surgeries (post-surgery for congenital heart disease, etc.), genetic metabolic diseases (such as cystic fibrosis), burns and severe trauma, energy metabolism-related diseases (diabetes, cerebral palsy, etc.), premature birth, tumors, diseases with abnormal intestinal structure development (megacolon, gastric torsion, etc.);
* 3\. Having consumed probiotics or formula milk containing probiotics in the past two weeks;
* 4\. Having used antibiotics in the past two months;
* 5\. Having participated in drug clinical research in the past three months;
* 6\. Refusing random grouping.

Where it's running

• Zhongshan Hospital Affiliated to Dalian University
  Dalian, Liaoning, China Recruiting

Study contacts

• Study coordinator: Ming Li
• Email: vivianmarat@163.com
• Phone: 180 1892 3363

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.