Gastrointestinal MicrobiomeNCT03388112
Shanghai Infants Gut Microbiome Associated Study
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 treated with antibiotics. 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
- 20 Feb 2017to 31 Dec 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 1 hour to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns with infectious diseases treated with antibiotic
Who cannot join
- Gestational weeks <37
- Birth weight <2500g or ≥4000g
- History of asphyxia anoxia at birth
- 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, Shanghai Municipality, 200072
Rong Yang, MD, 13321917107, leexuechun1@126.com
Huanlong Qin, PhD
About this study
Official title: Effects of Probiotics on the Gut Microbiome of Infants Treated With Antibiotics
The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of infants treated with antibiotics.
Read the detailed description
This study aims to examin the impact of probiotics under 2 separate conditions, probiotics concurrent administration with antibiotic and probiotics administration during the recovery phase.Birth,7 days,14 days(or 21 days) and 42 days data will be collected and put into analysis to provide somes suggestions on the probiotics use in the clinical for the infants treated with antibiotics.
- Conditions
- Gastrointestinal Microbiome
- Being tested
- Probiotics
- Keywords
- Probiotics,Gut Microbiome,Antibiotics,Infants
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 |
|---|---|---|
| antibiotics | No intervention | the patients in this arm will not receive probiotics. |
| probiotics concurrent with antibiotic | Experimental | the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks concurrent with antibiotic. Receives: Dietary Supplement: Probiotics |
| probiotics after antibiotic | Experimental | the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks after antibiotic. 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(or 21 days) on gut mcrobiome at 42 days
change of the gut mcrobiome will be calculated at 42 days in comparison with birth,7 days,14 days(or 21 days)
Measured: 42 days
Secondary outcomes (2)
change from birth on gut mcrobiome at 7 days
change of the gut mcrobiome will be calculated at 7 days in comparison with baseline
Measured: 7 days
change from birth and 7 days on gut mcrobiome at 14 days(or 21 days)
change of the gut mcrobiome will be calculated at 14(or 21 days) in comparison with birth and 7 days
Measured: 14 days（or 21days）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start20 Feb 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2018 (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
- NCT03388112
- Sponsor's protocol ID
- SHSYEK2017
- Status last verified
- Dec 2017
- First submitted
- 23 Dec 2017
- Last updated
- 2 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotics on the Gut Microbiome of Infants Treated With Antibiotics
- ClinicalTrials.gov ID
- NCT03388112
- Acronym / sponsor ID
- SHSYEK2017
- Conditions
- Gastrointestinal Microbiome
- Keywords
- Probiotics,Gut Microbiome,Antibiotics,Infants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 2 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 purpose of this study is to evaluate the effect of probiotics on the gut microbiome of infants treated with antibiotics.
Detailed description
This study aims to examin the impact of probiotics under 2 separate conditions, probiotics concurrent administration with antibiotic and probiotics administration during the recovery phase.Birth,7 days,14 days(or 21 days) and 42 days data will be collected and put into analysis to provide somes suggestions on the probiotics use in the clinical for the infants treated with antibiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| antibiotics | No intervention | –the patients in this arm will not receive probiotics. |
| probiotics concurrent with antibiotic | Experimental | Dietary Supplement: Probioticsthe patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks concurrent with antibiotic. |
| probiotics after antibiotic | Experimental | Dietary Supplement: Probioticsthe patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks after antibiotic. |
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 infectious diseases treated with antibiotic
Key exclusion criteria (5 listed)
- Gestational weeks <37
- Birth weight <2500g or ≥4000g
- History of asphyxia anoxia at birth
- 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 after antibiotic, probiotics concurrent with antibiotic |
Primary outcome
change from birth,7 days,14 days(or 21 days) on gut mcrobiome at 42 days
Time frame: 42 days
change of the gut mcrobiome will be calculated at 42 days in comparison with birth,7 days,14 days(or 21 days)
2 secondary outcomes
change from birth on gut mcrobiome at 7 days
Time frame: 7 days
change from birth and 7 days on gut mcrobiome at 14 days(or 21 days)
Time frame: 14 days（or 21days）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Individual participant dataSharing planned: No
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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 5 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 2 Jan 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 Yang Rong, 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(or 21 days) on gut mcrobiome at 42 days (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 2 Jan 2018.