Intestinal Growth of Young ChildrenN1115BabyNCT03416595
A Study on Efficacy of Feeding N1115 Probiotic Supplement to Young Children
A study testing N1115 Probiotic Supplement in people with Intestinal Growth of Young Children, run by Junlebao Dairy Group Co., Ltd. at 1 site in Ireland.
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… Read more about this study
- Who is it for?
- Ages 6 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Growth of Young Children
- What is being tested?
- N1115 Probiotic Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIreland
- Study dates
- 18 Sep 2017to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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),
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Intestinal Growth of Young Children
- Being tested
- N1115 Probiotic Supplement, placebo
- Keywords
- probiotic, Lactobacillus paracasei N1115, young children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N1115 Probiotic SupplementDietary supplement
Also called Junlebao Lp. N1115
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.
placeboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (2)
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
Measured: study week 0, 4 and 8
Salivary cortisol
Analysis changes in salivary cortisol, using chemiluminescence immunoassay detection, both in intervention group and placebo group
Measured: study week 0, 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start18 Sep 2017
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Growth of Young ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Junlebao Dairy Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials, Teagasc
- Responsible party
- Sponsor
- Investigators
- Barry Skillington, Postgraduate, Study director, The director of this clinical trial in Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416595
- Sponsor's protocol ID
- Lp. N1115 in Young Children
- Acronym
- N1115Baby
- Status last verified
- Jan 2018
- First submitted
- 11 Jan 2018
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03416595
- Acronym / sponsor ID
- N1115Baby / Lp. N1115 in Young Children
- Conditions
- Intestinal Growth of Young Children
- Keywords
- probiotic, Lactobacillus paracasei N1115, young children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Junlebao Dairy Group Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials, Teagasc
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| N1115 Probiotic Supplement | Active comparator | Dietary Supplement: N1115 Probiotic SupplementA 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). |
| Placebo control | Placebo comparator | Dietary Supplement: placeboDietary Supplement: Placebo Participators, who met inclusion criteria, will receive an identical N1115 Probiotic Supplement looking and tasting placebo. |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N1115 Probiotic SupplementAlso: Junlebao Lp. N1115Participators 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. | Dietary supplement | N1115 Probiotic Supplement |
| placeboParticipators 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. | Dietary supplement | Placebo control |
Primary outcome
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.
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.
2 secondary outcomes
Fecal microbiota
Time frame: study week 0, 4 and 8
Salivary cortisol
Time frame: study week 0, 4 and 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry Skillington, Postgraduate study director
The director of this clinical trial in Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N1115 Probiotic Supplement in people with Intestinal Growth of Young Children, run by Junlebao Dairy Group Co., Ltd. at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defecation improvement (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.