Congenital Heart DiseaseNCT06295575
Effect of Probiotics on Patients With Congenital Heart Disease Following Cardiopulmonary Bypass
A study testing probiotics containing Bifidobacterium infantis and Lactobacillus in people with Congenital Heart Disease and Intestinal Disease, run by Nanjing Children's Hospital at 1 site in China.
Trial summary
A randomized, controlled study including infants with non-cyanosis congenital heart disease (CHD) in need of surgical correction involving cardiopulmonary bypass (CPB) was established. Infants aged 1 month to 1 years were enrolled between June 2021 and July 2022. Read more about this study
- Who is it for?
- Ages 1 month to 1 year
- Conditions the study is for
- Congenital Heart Disease, Intestinal Disease, Dysbiosis
- What is being tested?
- probiotics containing Bifidobacterium infantis and Lactobacillus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 Jul 2022
- 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 month to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- a diagnosis of CHD requiring surgical repair with the use of CPB
- age greater than 37 weeks corrected gestational age and less than 1 year old
Who cannot join
- Patients with inherited metabolic disease, history of intestinal surgery, preexisting gastrointestinal pathology (such as NEC, IBS, inflammatory bowel disease, chronic intestinal obstruction or diarrhea), immunity dysfunction or received antibiotics, probiotics or hormone-replacement therapy within 2 months before enrollment were excluded from the study
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210093
About this study
Official title: The Effect of Probiotics on Intestinal Barrier Function and Intestinal Flora in Infants With Congenital Heart Disease Undergoing Cardiopulmonary Bypass
A randomized, controlled study including infants with non-cyanosis congenital heart disease (CHD) in need of surgical correction involving cardiopulmonary bypass (CPB) was established. Infants aged 1 month to 1 years were enrolled between June 2021 and July 2022. The patients in treatment group were supplied with probiotics consisting of Bifidobacterium infantis and Lactobacillus perioperatively and patients in control group were provided with placebo. Data concerning patients' clinical outcome such as diarrhea were collected. Blood samples were collected for measurement of fatty acid binding protein 2 (FABP2), diamine oxidase (DAO), d-lactic acid (D-LA) and C-reactive protein (CRP). Stool samples were collected to investigate the changes of intestinal flora.
- Conditions
- Congenital Heart Disease, Intestinal Disease, Dysbiosis
- Being tested
- probiotics containing Bifidobacterium infantis and Lactobacillus, placebos containing lactose
- Medical subject headings
- Heart Defects, Congenital, Intestinal Diseases, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotics containing Bifidobacterium infantis and LactobacillusDietary supplement
Patients were provided with probiotics containing Bifidobacterium infantis and Lactobacillus. This intervention was started the day after patients' administration and lasted until the day before discharge.
placebos containing lactoseDietary supplement
Patients received lactose as placebo.This intervention was started the day after patients' administration and lasted until the day before discharge.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | In treatment group, patients received 1×109 colony forming units (CFU) /day of probiotic, which was provided by Hangzhou Grand Biologic Pharmaceutical INC (Zhejiang, China) in the form of freeze-dried powder containing Bifidobacterium infantis and Lactobacillus with a density of 109 CFU/g. The probiotic powder was mixed with lactose and portioned into sachets with the help of Nanjing Medical University Central Pharmacy. Receives: Dietary Supplement: probiotics containing Bifidobacterium infantis and Lactobacillus |
| Control group | Placebo comparator | Patients in the control group received lactose as placebo. The placebo was packed in sachets and provided in the same way as treatment group. Receives: Dietary Supplement: placebos containing lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of morbidity
morbidity of intestinal diseases including pathology verified by imageological examination such as necrotizing enterocolitis (NEC) and acute intestinal obstruction or bowel dysfunction such as diarrhea
Measured: up to 1 months
gastrointestinal functional recovery indicators
starting time of full enteral feeding (hours post-surgery) and duration of gastrointestinal decompression were recorded for assessment of gastrointestinal functional recovery
Measured: up to 1 months
biomarkers
serum concentrations of biomarkers of intestinal barrier function and intestinal inflammation, namely IFABP, DAO, D-LA and CRP, were recorded
Measured: after anesthesia induction preoperatively and at 24 hour postoperatively
microbiome
16s rDNA sequencing
Measured: before surgery: within 24 hours after enrollment in the control group and within 24 hours preoperatively in the treatment group after surgery:between 48 and 72 hours in both groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Jun 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhixuan Zhang, Nanjing Children's Hospital
- Investigators
- Zhixuan Zhang, Principal investigator, Nanjing Children's HospitalXiaoxu Liu, Study director, Department of Cardiothoracic Surgery, Children's Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295575
- Sponsor's protocol ID
- ZZhang
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collation and website construction have not yet been completed
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotics on Intestinal Barrier Function and Intestinal Flora in Infants With Congenital Heart Disease Undergoing Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT06295575
- Acronym / sponsor ID
- ZZhang
- Conditions
- Congenital Heart Disease, Intestinal Disease, Dysbiosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nanjing Children's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 6 Mar 2024 (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.
A randomized, controlled study including infants with non-cyanosis congenital heart disease (CHD) in need of surgical correction involving cardiopulmonary bypass (CPB) was established. Infants aged 1 month to 1 years were enrolled between June 2021 and July 2022. The patients in treatment group were supplied with probiotics consisting of Bifidobacterium infantis and Lactobacillus perioperatively and patients in control group were provided with placebo. Data concerning patients' clinical outcome such as diarrhea were collected. Blood samples were collected for measurement of fatty acid binding protein 2 (FABP2), diamine oxidase (DAO), d-lactic acid (D-LA) and C-reactive protein (CRP). Stool samples were collected to investigate the changes of intestinal flora.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Dietary Supplement: probiotics containing Bifidobacterium infantis and LactobacillusIn treatment group, patients received 1×109 colony forming units (CFU) /day of probiotic, which was provided by Hangzhou Grand Biologic Pharmaceutical INC (Zhejiang, China) in the form of freeze-dried powder containing Bifidobacterium infantis and Lactobacillus with a density of 109 CFU/g. The probiotic powder was mixed with lactose and portioned into sachets with the help of Nanjing Medical University Central Pharmacy. |
| Control group | Placebo comparator | Dietary Supplement: placebos containing lactosePatients in the control group received lactose as placebo. The placebo was packed in sachets and provided in the same way as treatment group. |
Who may qualify
- Ages
- 1 month to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- a diagnosis of CHD requiring surgical repair with the use of CPB
- age greater than 37 weeks corrected gestational age and less than 1 year old
Key exclusion criteria (1 listed)
- Patients with inherited metabolic disease, history of intestinal surgery, preexisting gastrointestinal pathology (such as NEC, IBS, inflammatory bowel disease, chronic intestinal obstruction or diarrhea), immunity dysfunction or received antibiotics, probiotics or hormone-replacement therapy within 2 months before enrollment were excluded from the study
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 |
|---|---|---|
| probiotics containing Bifidobacterium infantis and LactobacillusPatients were provided with probiotics containing Bifidobacterium infantis and Lactobacillus. This intervention was started the day after patients' administration and lasted until the day before discharge. | Dietary supplement | Treatment group |
| placebos containing lactosePatients received lactose as placebo.This intervention was started the day after patients' administration and lasted until the day before discharge. | Dietary supplement | Control group |
Primary outcome
incidence of morbidity
Time frame: up to 1 months
morbidity of intestinal diseases including pathology verified by imageological examination such as necrotizing enterocolitis (NEC) and acute intestinal obstruction or bowel dysfunction such as diarrhea
gastrointestinal functional recovery indicators
Time frame: up to 1 months
starting time of full enteral feeding (hours post-surgery) and duration of gastrointestinal decompression were recorded for assessment of gastrointestinal functional recovery
biomarkers
Time frame: after anesthesia induction preoperatively and at 24 hour postoperatively
serum concentrations of biomarkers of intestinal barrier function and intestinal inflammation, namely IFABP, DAO, D-LA and CRP, were recorded
microbiome
Time frame: before surgery: within 24 hours after enrollment in the control group and within 24 hours preoperatively in the treatment group after surgery:between 48 and 72 hours in both groups
16s rDNA sequencing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: Yes. Data collation and website construction have not yet been completed
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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.
Zhixuan Zhang principal investigator
Nanjing Children's Hospital
Xiaoxu Liu study director
Department of Cardiothoracic Surgery, Children's Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China
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 containing Bifidobacterium infantis and Lactobacillus in people with Congenital Heart Disease and Intestinal Disease, run by Nanjing Children'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 2 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: finished, as of the sponsor's last update on 6 Mar 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
incidence of morbidity (time frame: up to 1 months). The study lists 4 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 6 Mar 2024.