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

NCT03416595 | Unknown

• 1 other identifier: Lp. N1115 in Young Children
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Intestinal Growth of Young Children

Keywords

probiotic; Lactobacillus paracasei N1115; young children

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Fecal microbiota

  study week 0, 4 and 8

• Salivary cortisol

  study week 0, 4 and 8

Study Arms (2)

N1115 Probiotic Supplement

ACTIVE COMPARATOR

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

Placebo control

PLACEBO COMPARATOR

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

Dietary Supplement: placebo

Interventions

N1115 Probiotic Supplement 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.

Also known as: Junlebao Lp. N1115

N1115 Probiotic Supplement

placebo 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

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Are currently taking probiotics or prebiotics, or have taken them in the past 2 weeks,
• Unwilling to avoid probiotics/prebiotics for the duration of the study,
• 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,
• 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),
• 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,
• Subjects have taken antibiotics within the past 3 months (history of antibiotic use in previous 6 months recorded),
• Subjects may not be receiving treatment involving experimental drugs,
• If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
• Subjects may not be receiving treatment involving experimental drugs,
• Exposure to any non-registered drug product within 30 days prior to screening visit.

Sponsors & Collaborators

• Junlebao Dairy Group Co., Ltd.: lead
• Atlantia Food Clinical Trials: collaborator
• Teagasc: collaborator

Study Sites (1)

Atlantia Clinical Food Trials

Cork, Blackrock, Ireland

Location

Study Officials

• Barry Skillington, Postgraduate

  The director of this clinical trial in Ireland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The model is a randomized, double-blinded, parallel, placebo-controlled intervention study to assess effect of N1115 Probiotic Supplement (containing Junlebao Lp. N1115) on gut development in young children. Up to 60 healthy children, between the ages of 6 months and 3 years who were born by caesarean section will be recruited into this study. Participants will be randomly assigned to one of two treatment groups, one group is N1115 Probiotic Supplement intervention which contains Lp. N1115 and maltodextrin, the other group is placebo intervention which contains maltodextrin only.

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 31, 2018
• Study Start: September 18, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: July 24, 2018

Record last verified: 2018-01

Locations

IE (1)