A Study on Efficacy of Feeding N1115 Probiotic Supplement to Young Children (N1115Baby)

A Randomized, Double-blinded, Parallel, Placebo-controlled Study to Investigate the Efficacy of Lb Paracasei [Junlebao Lp. N1115] as a Probiotic to Enhance Gut Development in Young Children

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.

Study Overview

• Status: Unknown
• Conditions: Intestinal Growth of Young Children
• Intervention / Treatment: Dietary supplement: N1115 Probiotic Supplement; Dietary supplement: placebo

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Blackrock
    • Cork, Blackrock, Ireland
      • Atlantia Clinical Food Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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).	Dietary supplement: N1115 Probiotic Supplement; 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.; Other Names: Junlebao Lp. N1115
PLACEBO_COMPARATOR: Placebo control; Dietary Supplement: Placebo Participators, who met inclusion criteria, will receive an identical N1115 Probiotic Supplement looking and tasting placebo.	Dietary supplement: placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	study week 0, 4 and 8
Salivary cortisol	Analysis changes in salivary cortisol, using chemiluminescence immunoassay detection, both in intervention group and placebo group	study week 0, 4 and 8

Collaborators and Investigators

• Sponsor: Shijiazhuang Junlebao Dairy Co., Ltd.
• Collaborators: Atlantia Food Clinical Trials; Teagasc
• Investigators: Study Director: Barry Skillington, Postgraduate, The director of this clinical trial in Ireland

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 18, 2017
• Primary Completion (ANTICIPATED): September 30, 2018
• Study Completion (ANTICIPATED): September 30, 2018

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: January 29, 2018
• First Posted (ACTUAL): January 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 24, 2018
• Last Update Submitted That Met QC Criteria: July 22, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: probiotic; young children; Lactobacillus paracasei N1115
• Other Study ID Numbers: Lp. N1115 in Young Children

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No