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A randomized controlled trial to investigate the efficacy of Lactobacillus paracasei N1115 as a probiotic to enhance health development in 6-24 months infants

A randomized controlled trial to investigate the efficacy of Lactobacillus paracasei N1115 as a probiotic to enhance health development in 6-24 months infants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026978
Enrollment
Unknown
Registered
2019-10-27
Start date
2019-12-01
Completion date
Unknown
Last updated
2019-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant intestinal health

Interventions

Experimental group:Take 1 bag, 2g/bag, 1x10^10cfu/g of bacterial powder containing Lactobacillus paracasei N1115 every day
take it with boiled water or milk at a temperature of no more than 40 degree C
the intervention time is 12 weeks.
Control group:Take 1 bag of placebo (mainly the excipient maltodextrin of Lactobacillus paracasei) in the same package every day, and take the same method for 12 weeks.

Sponsors

Peking University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 2 Years

Inclusion criteria

Inclusion criteria: 1. ceasarean-born infants; 2. aged 6-24 months infants meeting the standard for healthy infants of their age group.

Exclusion criteria

Exclusion criteria: 1) subjects that have been taken prebiotics or probiotics 2 weeks before the beginning of the experiment or do not want to be stopped; 2) subjects with serious acute or chronic diseases (cardiovascular diseases, gastrointestinal diseases, endocrine diseases, immune system diseases, metabolic diseases or diseases that the researchers think are not suitable for the study); 3) subjects that are taking some drugs that are treated or taken are considered to interfere with the purpose of the study, increase the risk of the study or lead to the problem that the results of the study cannot be explained; 4) subjects that have a history of taking antibiotics in the past 3 months; 5) subjects do not accept the arrangement of random subjects; 6) subjects participate in other studies less than 60 days before this study.

Design outcomes

Primary

MeasureTime frame
stool consistency;intestinal microflora;

Secondary

MeasureTime frame
salivary cortisol;Faecal short chain fatty acids;Fecal slgA;

Countries

China

Contacts

Public ContactZhang Yumei

Peking University Health Science Center

zhangyumei@bjmu.edu.cn+86 010 82801575

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026