Gut MicrobiotaNCT05481866
Targeting Gut Microbiota and Metabolites for Very Preterm Infants Through Oropharyngeal Administration of Colostrum
A study testing Oropharyngeal administration of colostrum and Oropharyngeal administration of sterile water in people with Gut Microbiota and Metabolites, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
Background: Oropharyngeal administration of colostrum (OAC) has an immune stimulating effect on oropharyngeal-associated lymphoid tissue, and can also promote the maturation of the gastrointestinal tract. However, how OAC promotes intestinal maturation in preterm infants by altering the gut microbiota remains unclear. Read more about this study
- Who is it for?
- Ages Up to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota, Metabolites
- What is being tested?
- Oropharyngeal administration of colostrum and Oropharyngeal administration of sterile water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Oct 2022to Oct 2023
- 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 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- gestational age less than 32 weeks and birth weight less than 1500g;
- admission to NICU ≤ 24 hours;
- be able to start the agreement within 72 hours of birth.
Who cannot join
- birth asphyxia (defined as umbilical artery / first hour arterial PH < 7.0 or cardiopulmonary resuscitation in the delivery room);
- birth complicated with severe gastrointestinal malformations (such as intestinal atresia, esophago-tracheal fistula, intestinal rotation abnormalities, congenital megacolon);
- prenatal diagnosis of congenital chromosomal abnormalities or suspected congenital genetic metabolic diseases;
- maternal drug abuse or contraindications to breastfeeding (HIV and cytomegalovirus infection).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeting Gut Microbiota and Metabolites for Very Preterm Infants Through Oropharyngeal Administration of Colostrum: Protocol for a Multicenter Randomized Controlled Trial
Background: Oropharyngeal administration of colostrum (OAC) has an immune stimulating effect on oropharyngeal-associated lymphoid tissue, and can also promote the maturation of the gastrointestinal tract. However, how OAC promotes intestinal maturation in preterm infants by altering the gut microbiota remains unclear. We aim to assess the changes of gut microbiota and metabolites after OAC in very preterm infants.
Methods: A multicenter, double-blind, randomized controlled trial will be conducted in 3 large NICUs in Shenzhen, China, for preterm infants with gestational age less than 32 weeks and birth weight less than 1500g. The intervention group will be given 0.2ml colostrum for oropharyngeal administration every 3 hours, which will start between the first 48 to 72 hours and continue for 5 consecutive days; The control group will be given sterile water for oropharyngeal administration, and the administration scheme will be the same as above. Stool samples will be collected at the first defecation and the 7th day after birth. It is estimated that 320 preterm infants will participate in the study within 1 year. 16sRNA gene sequencing and liquid chromatography-mass spectrometry will be used to analyze the effect of OAC on gut microbiota and metabolites.
Discussion: The proposal advocates for the promotion of OAC as a safe and relatively beneficial initiative among neonatal intensive care units, and this initiative may contribute to the establishment of a dominant intestinal flora. Findings of this study may help to improve the health outcomes of preterm infants by constructing targeted gut microbiota in future studies.
Read the detailed description
Preterm infants with gestational age < 32 weeks and weight < 1500g will be evaluated. Infants who met the inclusion criteria will be randomly divided into two groups according to the ratio of 1:1. The intervention group will be given oropharyngeal colostrum every 3 hours for 5 days; the control group will be given sterile water with the same dosage and administration scheme. Stool samples will be collected at the first defecation and the 7th day to detect the gut microbiota and metabolites.
- Conditions
- Gut Microbiota, Metabolites
- Being tested
- Oropharyngeal administration of colostrum, Oropharyngeal administration of sterile water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oropharyngeal administration of colostrumOther
The intervention group will be given 0.2ml colostrum for oropharyngeal administration every 3 hours.
Oropharyngeal administration of sterile waterOther
The control group will be given 0.2ml sterile water for oropharyngeal administration every 3 hours.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group will be given colostrum for oropharyngeal administration | Experimental | The intervention group will be given 0.2ml colostrum for oropharyngeal administration every 3 hours, which will start between the first 48 to 72 hours and continue for 5 consecutive days. Receives: Other: Oropharyngeal administration of colostrum |
| The control group will be given sterile water for oropharyngeal administration | Placebo comparator | The control group will be given sterile water for oropharyngeal administration, and the administration scheme will be the same as above. Receives: Other: Oropharyngeal administration of sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
A between-group difference in gut microbial alpha diversity will be measured by Shannon diversity index at the 7th day.
Shannon diversity Index explains species richness and evenness, which is one of the alpha diversity indexes and less affected by rare species.
Measured: 1 year
Between-group differences in the concentration of fecal metabolites (short chain fatty acids) will be quantitatively measured by non targeted liquid chromatography-mass spectrometry (LC-MS) at the 7th day.
Non-targeted LC-MS will be used to evaluate short chain fatty acids and other organic acids and alcohols. The relative and absolute quantitative results of metabolites will be calculated by fold change (FC) value, and the difference of metabolite expression between the two groups will be explored.
Measured: 1 year
Secondary outcomes (5)
A between-group difference in the Simpson diversity index at the 7th day
Simpson diversity index explains species richness, which is one of the alpha diversity indexes and susceptible to rare species.
Measured: 1 year
A between-group difference in the Chao1 diversity index at the 7th day.
Chao1 diversity index explains species richness, which is one of the alpha diversity indexes.
Measured: 1 year
Proportion of gut microbiota (phylum and genus level）at the 7th day.
After preprocessing to remove low-quality sequences, the original data will be analyzed according to the steps of 16S rRNA discovery, clustering and identification. Calculate the number of operational taxonomic units (OTUs) of each sample at a 97% sequence similarity level. A specific taxonomic units represents a specific species.
Measured: 1 year
Gut microbial beta diversity explaining between-sample dissimilarity will be calculated using the Vegan package.
Adonis permutational multivariate analysis of variance of Bray-Curtis distances with 9999 permutations will be used to compare the microbial community structure between each of the two groups at the 7th day.
Measured: 1 year
Correlation between dominant microbiota and metabolites
The correlation between the relative abundance of dominant bacterial taxa from 16S rRNA gene sequencing and the intensity of metabolites of interest will be determined by sparse partial least squares regression (SPLs) at the first defecation at the 7th day.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gut MicrobiotaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Bao'an Maternal and Child Health Hospital, Longgang Maternal and Child Health Hospital, Shenzhen, Guangdong
- Responsible party
- Sponsor
- Investigators
- Zhangbin Yu, PhD, Principal investigator, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481866
- Sponsor's protocol ID
- SZPH-2022-52
- Status last verified
- Jul 2022
- First submitted
- 20 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang N, Zhang J, Yu Z, Yan X, Zhang L, Peng H, Chen C, Li R. Oropharyngeal administration of colostrum targeting gut microbiota and metabolites in very preterm infants: protocol for a multicenter randomized controlled trial. BMC Pediatr. 2023 Oct 16;23(1):508. doi: 10.1186/s12887-023-04346-x.
PubMed 37845612
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Gut Microbiota and Metabolites for Very Preterm Infants Through Oropharyngeal Administration of Colostrum: Protocol for a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05481866
- Acronym / sponsor ID
- SZPH-2022-52
- Conditions
- Gut Microbiota, Metabolites
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Collaborators
- Shenzhen Bao'an Maternal and Child Health Hospital, Longgang Maternal and Child Health Hospital, Shenzhen, Guangdong
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 1 Aug 2022 (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.
Background: Oropharyngeal administration of colostrum (OAC) has an immune stimulating effect on oropharyngeal-associated lymphoid tissue, and can also promote the maturation of the gastrointestinal tract. However, how OAC promotes intestinal maturation in preterm infants by altering the gut microbiota remains unclear. We aim to assess the changes of gut microbiota and metabolites after OAC in very preterm infants.
Methods: A multicenter, double-blind, randomized controlled trial will be conducted in 3 large NICUs in Shenzhen, China, for preterm infants with gestational age less than 32 weeks and birth weight less than 1500g. The intervention group will be given 0.2ml colostrum for oropharyngeal administration every 3 hours, which will start between the first 48 to 72 hours and continue for 5 consecutive days; The control group will be given sterile water for oropharyngeal administration, and the administration scheme will be the same as above. Stool samples will be collected at the first defecation and the 7th day after birth. It is estimated that 320 preterm infants will participate in the study within 1 year. 16sRNA gene sequencing and liquid chromatography-mass spectrometry will be used to analyze the effect of OAC on gut microbiota and metabolites.
Discussion: The proposal advocates for the promotion of OAC as a safe and relatively beneficial initiative among neonatal intensive care units, and this initiative may contribute to the establishment of a dominant intestinal flora. Findings of this study may help to improve the health outcomes of preterm infants by constructing targeted gut microbiota in future studies.
Detailed description
Preterm infants with gestational age < 32 weeks and weight < 1500g will be evaluated. Infants who met the inclusion criteria will be randomly divided into two groups according to the ratio of 1:1. The intervention group will be given oropharyngeal colostrum every 3 hours for 5 days; the control group will be given sterile water with the same dosage and administration scheme. Stool samples will be collected at the first defecation and the 7th day to detect the gut microbiota and metabolites.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group will be given colostrum for oropharyngeal administration | Experimental | Other: Oropharyngeal administration of colostrumThe intervention group will be given 0.2ml colostrum for oropharyngeal administration every 3 hours, which will start between the first 48 to 72 hours and continue for 5 consecutive days. |
| The control group will be given sterile water for oropharyngeal administration | Placebo comparator | Other: Oropharyngeal administration of sterile waterThe control group will be given sterile water for oropharyngeal administration, and the administration scheme will be the same as above. |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- gestational age less than 32 weeks and birth weight less than 1500g;
- admission to NICU ≤ 24 hours;
- be able to start the agreement within 72 hours of birth.
Key exclusion criteria (4 listed)
- birth asphyxia (defined as umbilical artery / first hour arterial PH < 7.0 or cardiopulmonary resuscitation in the delivery room);
- birth complicated with severe gastrointestinal malformations (such as intestinal atresia, esophago-tracheal fistula, intestinal rotation abnormalities, congenital megacolon);
- prenatal diagnosis of congenital chromosomal abnormalities or suspected congenital genetic metabolic diseases;
- maternal drug abuse or contraindications to breastfeeding (HIV and cytomegalovirus infection).
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 |
|---|---|---|
| Oropharyngeal administration of colostrumThe intervention group will be given 0.2ml colostrum for oropharyngeal administration every 3 hours. | Other | The intervention group will be given colostrum for oropharyngeal administration |
| Oropharyngeal administration of sterile waterThe control group will be given 0.2ml sterile water for oropharyngeal administration every 3 hours. | Other | The control group will be given sterile water for oropharyngeal administration |
Primary outcome
A between-group difference in gut microbial alpha diversity will be measured by Shannon diversity index at the 7th day.
Time frame: 1 year
Shannon diversity Index explains species richness and evenness, which is one of the alpha diversity indexes and less affected by rare species.
Between-group differences in the concentration of fecal metabolites (short chain fatty acids) will be quantitatively measured by non targeted liquid chromatography-mass spectrometry (LC-MS) at the 7th day.
Time frame: 1 year
Non-targeted LC-MS will be used to evaluate short chain fatty acids and other organic acids and alcohols. The relative and absolute quantitative results of metabolites will be calculated by fold change (FC) value, and the difference of metabolite expression between the two groups will be explored.
5 secondary outcomes
A between-group difference in the Simpson diversity index at the 7th day
Time frame: 1 year
A between-group difference in the Chao1 diversity index at the 7th day.
Time frame: 1 year
Proportion of gut microbiota (phylum and genus level）at the 7th day.
Time frame: 1 year
Gut microbial beta diversity explaining between-sample dissimilarity will be calculated using the Vegan package.
Time frame: 1 year
Correlation between dominant microbiota and metabolites
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Derived from this study: PubMed 37845612Wang N, Zhang J, Yu Z, Yan X, Zhang L, Peng H, Chen C, Li R. Oropharyngeal administration of colostrum targeting gut microbiota and metabolites in very preterm infants: protocol for a multicenter randomized controlled trial. BMC Pediatr. 2023 Oct 16;23(1):508. doi: 10.1186/s12887-023-04346-x.
- 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.
Zhangbin Yu, PhD principal investigator
Shenzhen 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 Oropharyngeal administration of colostrum and Oropharyngeal administration of sterile water in people with Gut Microbiota and Metabolites, run by Shenzhen 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 3 inclusion and 4 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 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhangbin Yu, PhD (13913994149, yuzhangbin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A between-group difference in gut microbial alpha diversity will be measured by Shannon diversity index at the 7th day. (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT05481866, which also lists 1 linked publication.
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 Aug 2022.