Status:
UNKNOWN
A Study on Efficacy of Feeding N1115 Probiotic Supplement to Young Children
Lead Sponsor:
Junlebao Dairy Group Co., Ltd.
Collaborating Sponsors:
Atlantia Food Clinical Trials
Teagasc
Conditions:
Intestinal Growth of Young Children
Eligibility:
All Genders
6-3 years
Phase:
NA
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 wa...
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 fee...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03416595
Start Date
September 18 2017
End Date
September 30 2018
Last Update
July 24 2018
Active Locations (1)
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1
Atlantia Clinical Food Trials
Cork, Blackrock, Ireland