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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03416595 |
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Date of registration:
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11/01/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study on Efficacy of Feeding N1115 Probiotic Supplement to Young Children
N1115Baby |
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Scientific title:
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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 |
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Date of first enrolment:
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September 18, 2017 |
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Target sample size:
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60 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03416595 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Barry Skillington, Postgraduate |
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Address:
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Telephone:
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Email:
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Affiliation:
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The director of this clinical trial in Ireland |
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Key inclusion & exclusion criteria
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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.
Age minimum:
6 Months
Age maximum:
3 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Intestinal Growth of Young Children
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Intervention(s)
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Dietary Supplement: placebo
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Dietary Supplement: N1115 Probiotic Supplement
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Primary Outcome(s)
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Defecation improvement
[Time Frame: 8 weeks]
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GI symptoms
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Salivary cortisol
[Time Frame: study week 0, 4 and 8]
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Fecal microbiota
[Time Frame: study week 0, 4 and 8]
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Secondary ID(s)
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Lp. N1115 in Young Children
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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