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

NCT ID: NCT03416595

Last Updated: 2018-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-18
• Study Completion Date: 2018-09-30

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.

Conditions

Intestinal Growth of Young Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

N1115 Probiotic Supplement

Intervention Type: DIETARY_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.

Placebo control

Dietary Supplement: Placebo Participators, who met inclusion criteria, will receive an identical N1115 Probiotic Supplement looking and tasting placebo.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Junlebao Lp. N1115

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atlantia Food Clinical Trials

INDUSTRY

Sponsor Role: collaborator

Teagasc

INDUSTRY

Sponsor Role: collaborator

Junlebao Dairy Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barry Skillington, Postgraduate

Role: STUDY_DIRECTOR

The director of this clinical trial in Ireland

Locations

Atlantia Clinical Food Trials

Cork, Blackrock, Ireland

Countries

Ireland

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

Lp. N1115 in Young Children

Identifier Type: -

Identifier Source: org_study_id