Preterm InfantsNOD2-PilotNCT06782061
Activation of NOD2 Receptors in Preterm Infants by Lactobacillus Reuteri DSM17938
A study testing DSM17938+Routine clinical treatment in people with Preterm Infants, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Primary Objective: To evaluate the capacity of Lactobacillus reuteri DSM17938 to activate NOD2 receptors in preterm infants. Secondary Objective: To analyze the impact of Lactobacillus reuteri DSM17938 on the gut microbiome of preterm infants Read more about this study
- Who is it for?
- Ages Up to 72 hours
- Conditions the study is for
- Preterm Infants
- What is being tested?
- DSM17938+Routine clinical treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2024to 19 Jan 2025
- 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 Up to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants with a gestational age of less than 37 weeks.
- Birth weight of less than 2500 grams.
- Hospitalized within 72 hours after birth.
- Parents or legal guardians have signed an informed consent form.
Who cannot join
- Congenital digestive tract malformations, genetic metabolic diseases, or congenital immunodeficiency diseases.
- A history of severe asphyxia, infection, or liver and kidney dysfunction at birth/enrollment.
- Death within 72 hours after birth.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Official title: A Pilot Study on the Activation of NOD2 Receptors in Preterm Infants by Lactobacillus Reuteri DSM17938
Primary Objective: To evaluate the capacity of Lactobacillus reuteri DSM17938 to activate NOD2 receptors in preterm infants.
Secondary Objective: To analyze the impact of Lactobacillus reuteri DSM17938 on the gut microbiome of preterm infants
Read the detailed description
This study was designed as an open-label, stratified, randomized, parallel-controlled pilot study, using gestational age as the stratification factor. Participants were stratified according to birth gestational age < 32 weeks, 32 weeks ≤ birth gestational age < 37 weeks, and simple randomization method was used in each gestational age group. All subjects were enrolled after birth/hospital admission, and the experimental group started intervention at 10-14 days after birth, and the intervention period was 14 days.
- Conditions
- Preterm Infants
- Being tested
- DSM17938+Routine clinical treatment
- Keywords
- DSM17938, NOD2, preterm infant
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSM17938+Routine clinical treatmentOther
Lactobacillus reuteri DSM17938，5 drops per day by mouth (containing at least 100 million CFU of Lactobacillus reuteri DSM17938)，Routine clinical treatment
| Study group | Role | What they receive |
|---|---|---|
| DSM17938+Routine clinical treatment | Experimental | Lactobacillus reuteri DSM17938，5 drops per day by mouth (containing at least 100 million CFU of Lactobacillus reuteri DSM17938) Receives: Other: DSM17938+Routine clinical treatment |
| Routine clinical treatment | No intervention | Routine clinical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of NOD2 ligand in fecal samples
The supernatants of fecal samples were used to examine the content of NOD2 ligand with the human NOD2/NF-κB/secreted embryonic alkaline phosphatase (SEAP) reporter HEK293 cell
Measured: Pre-intervention Phase: On the 3rd day after birth (V1), 7th day (V2), and 10th day (V3). Intervention Phase: During the intervention period, on the 2nd day (V4), 4th day (V5), 6th day (V6), 8th day (V7), 10th day (V8), 12th day (V9), and 14th day (V10)
Secondary outcomes (2)
Relative Abundance of Operational Taxonomic Units (OTUs) in Fecal Samples
DNA extraction was performed using the QIAamp Mini Kit following the manufacturer's instructions. The V4 hypervariable region of the 16S ribosomal RNA (rRNA) gene was amplified and sequenced on an Illumina ISEQ 100 platform, generating 250 bp paired-end reads. Raw sequencing data quality was assessed and controlled using fastp (v0.23.2). Adapter sequences corresponding to the V3-V4 region were removed with cutadapt. Amplicon sequence variants (ASVs) were identified by denoising the paired-end FASTQ files with DADA2 (v1.6.0) in R. Representative sequences were aligned using the PyNAST algorithm (v1.2.2), and a phylogenetic tree was constructed with FastTree (v2.1.3). Taxonomic classification of ASVs was performed using the Ribosomal Database Project (RDP) classifier against the Greengenes database. To minimize biases from variations in sequencing depth, all samples were rarefied before downstream analyses.
Measured: Pre-intervention Phase: On the 3rd day after birth (V1), 7th day (V2), and 10th day (V3). Intervention Phase: During the intervention period, on the 2nd day (V4), 4th day (V5), 6th day (V6), 8th day (V7), 10th day (V8), 12th day (V9), and 14th day (V10)
Concentration of DSM17938 per Gram of Feces Quantified by qPCR
Quantitative fluorescence PCR (qPCR) was used to detect DSM17938
Measured: Pre-intervention Phase: On the 3rd day after birth (V1), 7th day (V2), and 10th day (V3). Intervention Phase: During the intervention period, on the 2nd day (V4), 4th day (V5), 6th day (V6), 8th day (V7), 10th day (V8), 12th day (V9), and 14th day (V10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start26 Dec 2024
- Primary completion19 Jan 2025
- Study completion19 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Shen, Doctor, Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782061
- Sponsor's protocol ID
- NFEC-2024-654
- Acronym
- NOD2-Pilot
- Status last verified
- Jan 2025
- First submitted
- 24 Dec 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following study documentation will be made available for sharing: study protocol, statistical analysis plan, informed consent form, clinical study report, and analytic code.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Activation of NOD2 Receptors in Preterm Infants by Lactobacillus Reuteri DSM17938
- ClinicalTrials.gov ID
- NCT06782061
- Acronym / sponsor ID
- NOD2-Pilot / NFEC-2024-654
- Conditions
- Preterm Infants
- Keywords
- DSM17938, NOD2, preterm infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- 19 Jan 2025 (actual)
- Study completion
- 19 Jan 2025 (actual)
- First posted
- 17 Jan 2025 (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.
Primary Objective: To evaluate the capacity of Lactobacillus reuteri DSM17938 to activate NOD2 receptors in preterm infants.
Secondary Objective: To analyze the impact of Lactobacillus reuteri DSM17938 on the gut microbiome of preterm infants
Detailed description
This study was designed as an open-label, stratified, randomized, parallel-controlled pilot study, using gestational age as the stratification factor. Participants were stratified according to birth gestational age < 32 weeks, 32 weeks ≤ birth gestational age < 37 weeks, and simple randomization method was used in each gestational age group. All subjects were enrolled after birth/hospital admission, and the experimental group started intervention at 10-14 days after birth, and the intervention period was 14 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel
| Arm | Type | Receives |
|---|---|---|
| DSM17938+Routine clinical treatment | Experimental | Other: DSM17938+Routine clinical treatmentLactobacillus reuteri DSM17938，5 drops per day by mouth (containing at least 100 million CFU of Lactobacillus reuteri DSM17938) |
| Routine clinical treatment | No intervention | –Routine clinical treatment |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm infants with a gestational age of less than 37 weeks.
- Birth weight of less than 2500 grams.
- Hospitalized within 72 hours after birth.
- Parents or legal guardians have signed an informed consent form.
Key exclusion criteria (3 listed)
- Congenital digestive tract malformations, genetic metabolic diseases, or congenital immunodeficiency diseases.
- A history of severe asphyxia, infection, or liver and kidney dysfunction at birth/enrollment.
- Death within 72 hours after birth.
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 |
|---|---|---|
| DSM17938+Routine clinical treatmentLactobacillus reuteri DSM17938，5 drops per day by mouth (containing at least 100 million CFU of Lactobacillus reuteri DSM17938)，Routine clinical treatment | Other | DSM17938+Routine clinical treatment |
Primary outcome
Concentration of NOD2 ligand in fecal samples
Time frame: Pre-intervention Phase: On the 3rd day after birth (V1), 7th day (V2), and 10th day (V3). Intervention Phase: During the intervention period, on the 2nd day (V4), 4th day (V5), 6th day (V6), 8th day (V7), 10th day (V8), 12th day (V9), and 14th day (V10)
The supernatants of fecal samples were used to examine the content of NOD2 ligand with the human NOD2/NF-κB/secreted embryonic alkaline phosphatase (SEAP) reporter HEK293 cell
2 secondary outcomes
Relative Abundance of Operational Taxonomic Units (OTUs) in Fecal Samples
Time frame: Pre-intervention Phase: On the 3rd day after birth (V1), 7th day (V2), and 10th day (V3). Intervention Phase: During the intervention period, on the 2nd day (V4), 4th day (V5), 6th day (V6), 8th day (V7), 10th day (V8), 12th day (V9), and 14th day (V10)
Concentration of DSM17938 per Gram of Feces Quantified by qPCR
Time frame: Pre-intervention Phase: On the 3rd day after birth (V1), 7th day (V2), and 10th day (V3). Intervention Phase: During the intervention period, on the 2nd day (V4), 4th day (V5), 6th day (V6), 8th day (V7), 10th day (V8), 12th day (V9), and 14th day (V10)
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 22 Jan 2025.
- Individual participant dataSharing planned: Yes. The following study documentation will be made available for sharing: study protocol, statistical analysis plan, informed consent form, clinical study report, and analytic code.
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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.
Wei Shen, Doctor study chair
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DSM17938+Routine clinical treatment in people with Preterm Infants, run by Nanfang Hospital, Southern Medical University 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 4 inclusion and 3 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 22 Jan 2025. 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?
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?
Concentration of NOD2 ligand in fecal samples (time frame: Pre-intervention Phase: On the 3rd day after birth (V1), 7th day (V2), and 10th day (V3). Intervention Phase: During the intervention period, on the 2nd day (V4), 4th day (V5), 6th day (V6), 8th day (V7), 10th day (V8), 12th day (V9), and 14th day (V10)). 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 22 Jan 2025.