A Study on Efficacy of Feeding N1115 Probiotic Supplement to Young Children

Not Applicable

• Conditions: Intestinal Growth of Young Children
• Interventions: Dietary Supplement: N1115 Probiotic Supplement; Dietary Supplement: placebo

• Registration Number: NCT03416595
• Lead Sponsor: Junlebao Dairy Group Co., Ltd.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2017-09-18
• Status Verified: 2018-01
• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-29
• Study First Posted: 2018-01-31
• Last Update Submitted: 2018-07-22
• Last Update Posted: 2018-07-24
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male or female subjects aged ≥ 6 months and ≤ 3 years,
2. Child was born by caesarean section,
3. Parent/Guardian has given written informed consent,
4. Be in generally good health as determined by the investigator.

Exclusion Criteria

1. Are currently taking probiotics or prebiotics, or have taken them in the past 2 weeks,
2. Unwilling to avoid probiotics/prebiotics for the duration of the study,
3. Has any food allergies or an allergy or hypersensitivity to any component of the study products, including, milk proteins allergy or cow's milk allergy,
4. Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, endocrinological, immunological, metabolic or any condition which contraindicates, in the investigators judgement, entry to the study),
5. Having a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results,
6. Subjects have taken antibiotics within the past 3 months (history of antibiotic use in previous 6 months recorded),
7. Subjects may not be receiving treatment involving experimental drugs,
8. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
9. Subjects may not be receiving treatment involving experimental drugs,
10. Exposure to any non-registered drug product within 30 days prior to screening visit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N1115 Probiotic Supplement	N1115 Probiotic Supplement	A probiotic supplement containing Lactobacillus paracasei N1115 \[Junlebao Lp. N1115\] Participators, who met inclusion criteria, will receive following product during 8 weeks: N1115 Probiotic Supplement in the form of powder packaged in sachet (one sachet containing 10\^9 CFU Lp. N1115).
Placebo control	placebo	Dietary Supplement: Placebo Participators, who met inclusion criteria, will receive an identical N1115 Probiotic Supplement looking and tasting placebo.

Primary Outcome Measures

Name	Time	Method
Defecation improvement	8 weeks	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.
GI symptoms	8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Fecal microbiota	study week 0, 4 and 8	Analysis diversity of fecal microbiota, using 16S rRNA gene sequencing, both in intervention group and placebo group to study their gut microbiota composition
Salivary cortisol	study week 0, 4 and 8	Analysis changes in salivary cortisol, using chemiluminescence immunoassay detection, both in intervention group and placebo group

Trial Locations

Locations (1)

Atlantia Clinical Food Trials; 🇮🇪 Cork, Blackrock, Ireland