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A Study on Efficacy of Feeding N1115 Probiotic Supplement to Young Children (N1115Baby)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416595
Recruitment Status : Unknown
Verified January 2018 by Shijiazhuang Junlebao Dairy Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : January 31, 2018
Last Update Posted : July 24, 2018
Sponsor:
Collaborators:
Atlantia Food Clinical Trials
Teagasc
Information provided by (Responsible Party):
Shijiazhuang Junlebao Dairy Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Intestinal Growth of Young Children Dietary Supplement: N1115 Probiotic Supplement Dietary Supplement: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : September 18, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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).
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.
Other Name: Junlebao Lp. N1115

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




Primary Outcome Measures :
  1. Defecation improvement [ Time Frame: 8 weeks ]

    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.


  2. GI symptoms [ Time Frame: 8 weeks ]

    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.



Secondary Outcome Measures :
  1. Fecal microbiota [ Time Frame: study week 0, 4 and 8 ]
    Analysis diversity of fecal microbiota, using 16S rRNA gene sequencing, both in intervention group and placebo group to study their gut microbiota composition

  2. Salivary cortisol [ Time Frame: study week 0, 4 and 8 ]
    Analysis changes in salivary cortisol, using chemiluminescence immunoassay detection, both in intervention group and placebo group



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416595


Locations
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Ireland
Atlantia Clinical Food Trials
Cork, Blackrock, Ireland
Sponsors and Collaborators
Shijiazhuang Junlebao Dairy Co., Ltd.
Atlantia Food Clinical Trials
Teagasc
Investigators
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Study Director: Barry Skillington, Postgraduate The director of this clinical trial in Ireland
  Study Documents (Full-Text)

Documents provided by Shijiazhuang Junlebao Dairy Co., Ltd.:
Study Protocol  [PDF] January 11, 2018

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Responsible Party: Shijiazhuang Junlebao Dairy Co., Ltd.
ClinicalTrials.gov Identifier: NCT03416595    
Other Study ID Numbers: Lp. N1115 in Young Children
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shijiazhuang Junlebao Dairy Co., Ltd.:
probiotic
Lactobacillus paracasei N1115
young children