๐ฌIn plain words
What the trial is, and whether it could suit you
This is a probiotic intervention study in healthy infants aged 0 - 6 months. The primary objective is to evaluate the effects of Lacticaseibacillus paracasei LPB27 (also known as Lacticaseibacillus paracasei 207-27) supplementation on immune function, growth and development, and gut microbiota composition. The secondary objective is to assess its effects on defecation characteristics and gastrointestinal symptoms (bloating, diarrhea, abdominal pain).
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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.