Gastrointestinal MicrobiomeNCT03510936
Gut Microbiome Associated Study of Shanghai Infants With Jaundice
A study testing Probiotics in people with Gastrointestinal Microbiome, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of infants with jaundice. Read more about this study
- Who is it for?
- Ages 1 hour to 28 days
- Conditions the study is for
- Gastrointestinal Microbiome
- What is being tested?
- Probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Mar 2019
- 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 1 hour to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns with jaundice treated with blue light phototherapy
Who cannot join
- Gestational weeks <37 Birth weight <2500g or ≥4000g History of asphyxia anoxia at birth With infectious diseases treated with antibiotic With congenital metabolic diseases or hereditary diseases With gastrointestinal diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai 10th People's Hospital
Shanghai, 20072
Rong Yang, MD, 13321917107, leexuechun1@126.com
Huanlong Qin, PhD
About this study
Official title: Effect of Probiotics on the Gut Mircobiome of Infants With Jaundice
The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of infants with jaundice.
Read the detailed description
This study aims to examin the impact of probiotics administration during the process of infants jaundice treatment and recovery phase.the recovery phase.Birth,7 days,14 days and 42 days data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the infants with jaundice.
- Conditions
- Gastrointestinal Microbiome
- Being tested
- Probiotics
- Keywords
- Probiotics, Gut Microbiome, Infants, Jaundice
- Medical subject headings
- Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis with does of 1.5*10^7CFU for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| blue light phototherapy | No intervention | the patients in this arm will not receive probiotics. |
| probiotics concurrent with phototherapy | Experimental | the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks Receives: Dietary Supplement: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from birth,7 days,14 days on gut microbiome at 42 days by 16S rRNA
change of the gut microbiome will be calculated at 42 days in comparison with birth,7 days,14 days
Measured: 42 days
Secondary outcomes (2)
change from birth on gut microbiome at 7 days by 16S rRNA
change of the gut microbiome will be calculated at 7 days in comparison with baseline
Measured: 7 days
change from birth and 7 days on gut microbiome at 14 days by 16S rRNA
change of the gut microbiome will be calculated at 14 days in comparison with birth and 7 days
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start1 Jan 2018
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal MicrobiomeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huanlong Qin, Shanghai 10th People's Hospital
- Investigators
- Huanlong Qin, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510936
- Sponsor's protocol ID
- SHSYEK2018
- Status last verified
- May 2018
- First submitted
- 18 Apr 2018
- Last updated
- 23 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics on the Gut Mircobiome of Infants With Jaundice
- ClinicalTrials.gov ID
- NCT03510936
- Acronym / sponsor ID
- SHSYEK2018
- Conditions
- Gastrointestinal Microbiome
- Keywords
- Probiotics, Gut Microbiome, Infants, Jaundice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 27 Apr 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 purpose of this study is to evaluate the effect of probiotics on the gut microbiome of infants with jaundice.
Detailed description
This study aims to examin the impact of probiotics administration during the process of infants jaundice treatment and recovery phase.the recovery phase.Birth,7 days,14 days and 42 days data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the infants with jaundice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| blue light phototherapy | No intervention | –the patients in this arm will not receive probiotics. |
| probiotics concurrent with phototherapy | Experimental | Dietary Supplement: Probioticsthe patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks |
Who may qualify
- Ages
- 1 hour to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newborns with jaundice treated with blue light phototherapy
Key exclusion criteria (1 listed)
- Gestational weeks <37 Birth weight <2500g or ≥4000g History of asphyxia anoxia at birth With infectious diseases treated with antibiotic With congenital metabolic diseases or hereditary diseases With gastrointestinal diseases
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 |
|---|---|---|
| Probioticsthe patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis with does of 1.5*10^7CFU for 2 weeks | Dietary supplement | probiotics concurrent with phototherapy |
Primary outcome
change from birth,7 days,14 days on gut microbiome at 42 days by 16S rRNA
Time frame: 42 days
change of the gut microbiome will be calculated at 42 days in comparison with birth,7 days,14 days
2 secondary outcomes
change from birth on gut microbiome at 7 days by 16S rRNA
Time frame: 7 days
change from birth and 7 days on gut microbiome at 14 days by 16S rRNA
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
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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.
Huanlong Qin principal investigator
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Gastrointestinal Microbiome, run by Shanghai 10th People's Hospital at 1 site in China.
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 1 inclusion and 1 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 23 May 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 China. 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. 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?
Contact Rong Yang, MD (13321917107, leexuechun1@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from birth,7 days,14 days on gut microbiome at 42 days by 16S rRNA (time frame: 42 days). 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 23 May 2018.