The aim of the study is to examine the intervening effects of N1115 Probiotic Supplement (containing Junlebao Lp. N1115) on gut development in young children at the age of 6 month to 3 years by the way of a randomised, double-blinded, parallel, placebo-controlled clinical trial, and to explore the change of intestinal microbiota composition and healthy condition after intervention.
N1115 Probiotic Supplement contains Lactobacillus paracasei N1115 \[Junlebao Lp. N1115\], a lactobacillus bacteria strain isolated from traditional homemade yogurt in North China. In recent studys feeding Junlebao Lp. N1115 to C57BL/6 mice, the data suggest that Lp. N1115 enhances intestinal development in neonatal mice, and may confer benefits on the growth at early stage of life. This study is to investigate if a N1115 Probiotic Supplement product containing Lp. N1115 will improve intestinal health in young children. This randomised, double-blinded, placebo-controlled trial includes two treatment groups which respectively need to recruit 30 volunteers born by cesarean section and aged from 6 months to 3 years. The study group receives N1115 Probiotic Supplement, while the control group receives placebo. The trial lasts for 8 weeks and include four time points of data collection. The stool consistency of children will be recorded everyday, the saliva and stool samples will be collected and analysed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
Participators will receive a sachet each day during 8 weeks. The contents of the sachet should be added to warm water or milk, mixed until fully dissolved and served within 15 minutes.
Participators will receive a sachet each day during 8 weeks. The contents of the sachet should be added to warm water or milk, mixed until fully dissolved and served within 15 minutes.
Atlantia Clinical Food Trials
Cork, Blackrock, Ireland
Defecation improvement
Compare the defecation condition of child both in intervention group and placebo group by the way of recording the questionnaire each day. Record number of defecation and type of stool based on Bristol Stool Scale.
Time frame: 8 weeks
GI symptoms
Compare the gastrointestinal symptoms of child both in intervention group and placebo group by the way of recording the questionnaire each day. Record number of flatulence, bloating, cramps and diarrhea compared between child in intervention group and placebo group.
Time frame: 8 weeks
Fecal microbiota
Analysis diversity of fecal microbiota, using 16S rRNA gene sequencing, both in intervention group and placebo group to study their gut microbiota composition
Time frame: study week 0, 4 and 8
Salivary cortisol
Analysis changes in salivary cortisol, using chemiluminescence immunoassay detection, both in intervention group and placebo group
Time frame: study week 0, 4 and 8
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