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

Intestinal Growth of Young Children Clinical Trial

— N1115Baby  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03416595
• Other study ID #: Lp. N1115 in Young Children
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 18, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: January 2018
• Source: Shijiazhuang Junlebao Dairy Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Growth of Young Children

Intervention

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.
• 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.

Locations

Country	Name	City	State
Ireland	Atlantia Clinical Food Trials	Cork	Blackrock

Sponsors (3)

Lead Sponsor	Collaborator
Shijiazhuang Junlebao Dairy Co., Ltd.	Atlantia Food Clinical Trials, Teagasc

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Salivary cortisol	Analysis changes in salivary cortisol, using chemiluminescence immunoassay detection, both in intervention group and placebo group	study week 0, 4 and 8