Preterm BirthDenBaloNCT05730569
Description and Comparison of Biological Vulnerability in Small Vulnerable Newborns Versus Healthy Community Controls in Urban Burkina Faso
An observational study of Preterm Birth and Low Birth Weight, run by University Ghent at 1 site in Burkina Faso.
Trial summary
The aim of the DenBalo study is to apply integrated multi-omics methods to examine the biological mechanisms underlying this vulnerability in Small Vulnerable Newborns (SVNs) in LMICs, with the ultimate goal of identifying targeted interventions to reduce morbidity and mortality in this high-risk population. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Low Birth Weight, Small for Gestational Age at Delivery
- How many people
- 140 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 9 Jan 2023to 31 Jul 2024
- Phase
- Observational
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population is composed of all pregnant women at the beginning of the third trimester of their pregnancy attending regular antenatal consultations (ANC) at Accart-Ville, Colma 1 or Farakan health centers.
Who may be able to join
- Fundal height between 24 and 27 cm
- Woman living in the health zone of Accart-Ville, Colma 1 or Farakan
- Woman not planning to give birth or move outside the study area in the first 6 months of the infant's life
- Gestational age between 24 weeks 0 completed day and 29 weeks 6 days (ultrasound)
- Monofetal pregnancy without visible malformation
- Woman agreeing to give her informed consent to participate in the study
Show all 19Show fewer
- Delivery of a live birth
- Vaginal birth
- Absence of severe infectious pathology, severe pneumopathy or respiratory distress in the neonate
- Neonates who did not receive corticosteroids or antibiotics at birth
- For Small Vulnerable Newborns (SVNs):
- Low birth weight: <2500g; and/or,
- Preterm: born between the 34th and 37th week of pregnancy; and/or,
- Small for Gestational Age: <10 percentile of INTERGROWTH-21st birthweight standards.
- For healthy community controls:
- Neonate born after the 37th week of pregnancy; and,
- Birth weight >2500g; and,
- ≥10 percentile of INTERGROWTH-21st birthweight standards; and,
- Possible match with a SVN neonate already recruited into the study.
Who cannot join
- Fundal height <24 cm or >27 cm
- Woman living outside the sanitary zone of the Accart-Ville, Colma 1 or Farakan
- Woman planning to give birth outside the study area or to move from it within the first 6 months of the infants's life
- Gestational age <24 weeks or ≥30 weeks (ultrasound)
- Multi-fetal pregnancy
- Malformation visible on ultrasound
Show all 9Show fewer
- Cesarean delivery
- Neonate with severe infectious disease, severe pneumopathy or respiratory distress
- Neonate who received corticosteroids or antibiotics just after birth
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site, 1 recruiting
- Recruiting
Agence de Formation, de Recherche et d'Expertise en Santé pour l'Afrique (AFRICSanté)
Bobo-Dioulasso
Moctar Ouédraogo, MS, +22670238198, obmoctar@gmail.com
Laeticia C Toé, MD, MS
About this study
Official title: Description and Comparison of Biological Vulnerability in Small Vulnerable Newborns Versus Healthy Community Controls in Urban Burkina Faso (DenBalo): Gut Microbiota, Immune System, and Breastmilk Assembly and Development in the First Days and Weeks of Life
The aim of the DenBalo study is to apply integrated multi-omics methods to examine the biological mechanisms underlying this vulnerability in Small Vulnerable Newborns (SVNs) in LMICs, with the ultimate goal of identifying targeted interventions to reduce morbidity and mortality in this high-risk population. The evidence generated from this project will ultimately help promote healthy pregnancies and the birth of healthy babies.
To achieve this goal, three research objectives are proposed:
- To describe and compare gut microbiota, immune system and breastmilk components in SVNs versus healthy community controls in urban Burkina Faso.
- To describe and compare the development of the gut microbiota, the immune system and breastmilk components during the first six months of life in SVNs versus healthy community controls in urban Burkina Faso.
- To investigate the relationship between the composition of the gut microbiota, the immune system and breastmilk components during the first six months of life in SVNs versus healthy community controls in urban Burkina Faso.
Read the detailed description
The first days and weeks of life are characterized by a truly impressive cascade of biological processes that drive neonatal growth and development-all of which are crucial to preparing the newborn for life outside the womb.
First, vaginal delivery exposes neonates to an important natural microbial inoculum from the vaginal microbiota in labor and from the maternal intestinal microbiota at birth. Together, these early colonization events lay the foundation for gut microbiota assembly, inform the arrival of subsequent species through microbial interactions, and dictate infant microbiota maturation. A recent study has shown that a handful of bacteria begin colonizing the infant gut within the first days of life, that gut microbes accumulate gradually over time, and that pioneer strains are retained after a month of life. Whether the gut microbial assembly, maturation, and functional potential differs between SVNs versus healthy, community controls, or is coupled to growth and development, remains unresolved.
Secondly, the first days and weeks of life represent a time of heightened vulnerability to infectious disease. Neonatal infections account for a tragic 40% of mortality in children under five years of age. This critical time period is increasingly seen as a key determinant in health over the entire lifespan. A recent study using a high-dimensional, unbiased approach to characterize neonatal immune system development reported a dramatic, purposeful trajectory in the first week of life. While much remains to be explored, what is known is that early microbial colonization is vital to optimal host immune development and protection from disease and that, after birth, the most important determinant of infant gut colonization is breastfeeding. The impacts of preterm birth, low birth weight, or small for gestational age on immune development and function remain enigmatic and the mediating effect of the gut microbiome unknown.
Thirdly, neonatal nutrition plays a vital role in the two aforementioned processes-because breastfeeding both initiates tropic priming of the newborn gut and transfers numerous immunological factors to the baby. However, few studies have explored the synergy between neonatal microbiome and immunome development, and even fewer through the lens of newborn nutrition. Moreover, virtually zero studies include an integrated characterization of these processes in the SVN. Evidence suggests that, compared to mothers of full-term neonates, the colostrum from mothers of preterm newborns has higher protein and fat content, free amino acids, sodium, and bioactive milk components including HMOs, cytokines, and lactoferrin. But because few studies have evaluated the association between early milk composition and infant growth and development, it is unclear which components are most imperative for a healthy gut microbiota and a robust immune system, particularly in the SVN.
Major advances in systems biology approaches allowing for unbiased, integrated analyses of high-dimensional -omic databases have provided the critical bioinformatic toolkit required to address these questions. Indeed, the ground has never been more fertile for a step-change in commitment to high-impact research on neonatal microbiome and immunome development and the synergy with newborn nutrition.
- Keywords
- Preterm Birth, Low Birth Weight, Small for Gestational Age, Small Vulnerable Newborn
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Small Vulnerable Newborns | * Low birth weight: <2500g; and/or, * Preterm: born between the 34th and 37th week of pregnancy; and/or, * Small for Gestational Age: <10 percentile of INTERGROWTH-21st birthweight standards. | |
| Healthy Community Controls | * Born after the 37th week of pregnancy; and, * Birth weight ≥2500g; and, * ≥10 percentile of INTERGROWTH-21st birthweight standards. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential abundances of bacterial genera in the infant gut microbiota
Shotgun metagenomic sequencing
Measured: to be assessed at on days 3, 7, 14, 30, 60, 180 of life
Secondary outcomes (4)
Infant gut microbiota α and β diversity
Shotgun metagenomic sequencing
Measured: to be assessed at on days 3, 7, 14, 30, 60, 180 of life
Infant plasma immunophenotyping
Flow cytometry
Measured: to be assessed at birth and on days 1, 3, 5, 7, 30, 60 of life
Infant plasma chemokine and cytokine analyses
Electrochemiluminescence and the MSD V-PLEX Human Biomarker 54-Plex Kit
Measured: to be assessed at birth and on days 1, 3, 5, 7, 30, 60 of life
Maternal breastmilk component* profiling
*Components include macronutrients, micronutrients, oligosaccharides, growth factors, immunoglobulins, cytokines, metabolites, microbes, and proteins.
Measured: on days 3, 7, 14, 30, 60 of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start9 Jan 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche en Sciences de la Santé (IRSS), Université NAZI BONI, Hasselt University, University of Virginia, University Hospital, Ghent, Cedars-Sinai Medical Center, Sapient Bioanalytics, Stanford University, Centre Muraz, University of Manitoba, Manitoba Interdisciplinary Lactation Center (MILC), Agence de Formation, de Recherche & d'Expertise en Santé pour l'Afrique (AFRICSanté)
- Responsible party
- Sponsor
- Investigators
- Trenton Dailey-Chwalibóg, MPH, PhD, Principal investigator, University GhentCarl Lachat, MEng, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730569
- Sponsor's protocol ID
- ONZ-2022-0500
- Other IDs
- INV-035474 & INV-036154, 050-2022/CEIRES
- Acronym
- DenBalo
- Status last verified
- May 2024
- First submitted
- 12 Jan 2023
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the data collected during the DenBalo study will be pseudonymised (i.e., identifable data can still be linked to patient files by means of a code) and the key to the codes will only be accessible to the principal investigators, or his/her representative. The collected pseudonymised data as well as the collected biological samples can be shared with other (future) researchers for future research projects and studies, exclusively in the context of the same disease/pathology or similar (i.e., in the interest of research on maternal, newborn and child health). This will be done within a strictly legal framework and in compliance with international laws on the protection of personal data. Only anonymized data will be used in any type of documentation, reports or publications (in the medical scientific literature and/or at medical conferences). Personal patient data will be stored for at least 25 years after the end of the study.
Publications
Bennike TB, Fatou B, Angelidou A, Diray-Arce J, Falsafi R, Ford R, Gill EE, van Haren SD, Idoko OT, Lee AH, Ben-Othman R, Pomat WS, Shannon CP, Smolen KK, Tebbutt SJ, Ozonoff A, Richmond PC, van den Biggelaar AHJ, Hancock REW, Kampmann B, Kollmann TR, Levy O, Steen H. Preparing for Life: Plasma Proteome Changes and Immune System Development During the First Week of Human Life. Front Immunol. 2020 Oct 20;11:578505. doi: 10.3389/fimmu.2020.578505. eCollection 2020.
PubMed 33329546Bhutta ZA, Black RE. Global maternal, newborn, and child health--so near and yet so far. N Engl J Med. 2013 Dec 5;369(23):2226-35. doi: 10.1056/NEJMra1111853. No abstract available.
PubMed 24304052Bittinger K, Zhao C, Li Y, Ford E, Friedman ES, Ni J, Kulkarni CV, Cai J, Tian Y, Liu Q, Patterson AD, Sarkar D, Chan SHJ, Maranas C, Saha-Shah A, Lund P, Garcia BA, Mattei LM, Gerber JS, Elovitz MA, Kelly A, DeRusso P, Kim D, Hofstaedter CE, Goulian M, Li H, Bushman FD, Zemel BS, Wu GD. Bacterial colonization reprograms the neonatal gut metabolome. Nat Microbiol. 2020 Jun;5(6):838-847. doi: 10.1038/s41564-020-0694-0. Epub 2020 Apr 13.
PubMed 32284564Bode L. Human milk oligosaccharides: every baby needs a sugar mama. Glycobiology. 2012 Sep;22(9):1147-62. doi: 10.1093/glycob/cws074. Epub 2012 Apr 18.
PubMed 22513036Chu H, Mazmanian SK. Innate immune recognition of the microbiota promotes host-microbial symbiosis. Nat Immunol. 2013 Jul;14(7):668-75. doi: 10.1038/ni.2635.
PubMed 23778794Funkhouser LJ, Bordenstein SR. Mom knows best: the universality of maternal microbial transmission. PLoS Biol. 2013;11(8):e1001631. doi: 10.1371/journal.pbio.1001631. Epub 2013 Aug 20.
PubMed 23976878Granger CL, Embleton ND, Palmer JM, Lamb CA, Berrington JE, Stewart CJ. Maternal breastmilk, infant gut microbiome and the impact on preterm infant health. Acta Paediatr. 2021 Feb;110(2):450-457. doi: 10.1111/apa.15534. Epub 2020 Sep 16.
PubMed 33245565Jost T, Lacroix C, Braegger CP, Rochat F, Chassard C. Vertical mother-neonate transfer of maternal gut bacteria via breastfeeding. Environ Microbiol. 2014 Sep;16(9):2891-904. doi: 10.1111/1462-2920.12238. Epub 2013 Sep 3.
PubMed 24033881Kollmann TR, Kampmann B, Mazmanian SK, Marchant A, Levy O. Protecting the Newborn and Young Infant from Infectious Diseases: Lessons from Immune Ontogeny. Immunity. 2017 Mar 21;46(3):350-363. doi: 10.1016/j.immuni.2017.03.009.
PubMed 28329702Lee AH, Shannon CP, Amenyogbe N, Bennike TB, Diray-Arce J, Idoko OT, Gill EE, Ben-Othman R, Pomat WS, van Haren SD, Cao KL, Cox M, Darboe A, Falsafi R, Ferrari D, Harbeson DJ, He D, Bing C, Hinshaw SJ, Ndure J, Njie-Jobe J, Pettengill MA, Richmond PC, Ford R, Saleu G, Masiria G, Matlam JP, Kirarock W, Roberts E, Malek M, Sanchez-Schmitz G, Singh A, Angelidou A, Smolen KK; EPIC Consortium; Brinkman RR, Ozonoff A, Hancock REW, van den Biggelaar AHJ, Steen H, Tebbutt SJ, Kampmann B, Levy O, Kollmann TR. Dynamic molecular changes during the first week of human life follow a robust developmental trajectory. Nat Commun. 2019 Mar 12;10(1):1092. doi: 10.1038/s41467-019-08794-x.
PubMed 30862783Ma J, Li Z, Zhang W, Zhang C, Zhang Y, Mei H, Zhuo N, Wang H, Wang L, Wu D. Comparison of gut microbiota in exclusively breast-fed and formula-fed babies: a study of 91 term infants. Sci Rep. 2020 Sep 25;10(1):15792. doi: 10.1038/s41598-020-72635-x.
PubMed 32978424Makino H, Kushiro A, Ishikawa E, Kubota H, Gawad A, Sakai T, Oishi K, Martin R, Ben-Amor K, Knol J, Tanaka R. Mother-to-infant transmission of intestinal bifidobacterial strains has an impact on the early development of vaginally delivered infant's microbiota. PLoS One. 2013 Nov 14;8(11):e78331. doi: 10.1371/journal.pone.0078331. eCollection 2013.
PubMed 24244304Makino H, Kushiro A, Ishikawa E, Muylaert D, Kubota H, Sakai T, Oishi K, Martin R, Ben Amor K, Oozeer R, Knol J, Tanaka R. Transmission of intestinal Bifidobacterium longum subsp. longum strains from mother to infant, determined by multilocus sequencing typing and amplified fragment length polymorphism. Appl Environ Microbiol. 2011 Oct;77(19):6788-93. doi: 10.1128/AEM.05346-11. Epub 2011 Aug 5.
PubMed 21821739Melville JM, Moss TJ. The immune consequences of preterm birth. Front Neurosci. 2013 May 21;7:79. doi: 10.3389/fnins.2013.00079. eCollection 2013.
PubMed 23734091Mueller NT, Shin H, Pizoni A, Werlang IC, Matte U, Goldani MZ, Goldani HAS, Dominguez-Bello MG. Delivery Mode and the Transition of Pioneering Gut-Microbiota Structure, Composition and Predicted Metabolic Function. Genes (Basel). 2017 Dec 4;8(12):364. doi: 10.3390/genes8120364.
PubMed 29207565
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description and Comparison of Biological Vulnerability in Small Vulnerable Newborns Versus Healthy Community Controls in Urban Burkina Faso (DenBalo): Gut Microbiota, Immune System, and Breastmilk Assembly and Development in the First Days and Weeks of Life
- ClinicalTrials.gov ID
- NCT05730569
- Acronym / sponsor ID
- DenBalo / ONZ-2022-0500
- Keywords
- Preterm Birth, Low Birth Weight, Small for Gestational Age, Small Vulnerable Newborn
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Institut de Recherche en Sciences de la Santé (IRSS), Université NAZI BONI, Hasselt University, University of Virginia, University Hospital, Ghent, Cedars-Sinai Medical Center, Sapient Bioanalytics, Stanford University, Centre Muraz, University of Manitoba, Manitoba Interdisciplinary Lactation Center (MILC), Agence de Formation, de Recherche & d'Expertise en Santé pour l'Afrique (AFRICSanté)
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 16 Feb 2023 (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 aim of the DenBalo study is to apply integrated multi-omics methods to examine the biological mechanisms underlying this vulnerability in Small Vulnerable Newborns (SVNs) in LMICs, with the ultimate goal of identifying targeted interventions to reduce morbidity and mortality in this high-risk population. The evidence generated from this project will ultimately help promote healthy pregnancies and the birth of healthy babies.
To achieve this goal, three research objectives are proposed:
- To describe and compare gut microbiota, immune system and breastmilk components in SVNs versus healthy community controls in urban Burkina Faso.
- To describe and compare the development of the gut microbiota, the immune system and breastmilk components during the first six months of life in SVNs versus healthy community controls in urban Burkina Faso.
- To investigate the relationship between the composition of the gut microbiota, the immune system and breastmilk components during the first six months of life in SVNs versus healthy community controls in urban Burkina Faso.
Detailed description
The first days and weeks of life are characterized by a truly impressive cascade of biological processes that drive neonatal growth and development-all of which are crucial to preparing the newborn for life outside the womb.
First, vaginal delivery exposes neonates to an important natural microbial inoculum from the vaginal microbiota in labor and from the maternal intestinal microbiota at birth. Together, these early colonization events lay the foundation for gut microbiota assembly, inform the arrival of subsequent species through microbial interactions, and dictate infant microbiota maturation. A recent study has shown that a handful of bacteria begin colonizing the infant gut within the first days of life, that gut microbes accumulate gradually over time, and that pioneer strains are retained after a month of life. Whether the gut microbial assembly, maturation, and functional potential differs between SVNs versus healthy, community controls, or is coupled to growth and development, remains unresolved.
Secondly, the first days and weeks of life represent a time of heightened vulnerability to infectious disease. Neonatal infections account for a tragic 40% of mortality in children under five years of age. This critical time period is increasingly seen as a key determinant in health over the entire lifespan. A recent study using a high-dimensional, unbiased approach to characterize neonatal immune system development reported a dramatic, purposeful trajectory in the first week of life. While much remains to be explored, what is known is that early microbial colonization is vital to optimal host immune development and protection from disease and that, after birth, the most important determinant of infant gut colonization is breastfeeding. The impacts of preterm birth, low birth weight, or small for gestational age on immune development and function remain enigmatic and the mediating effect of the gut microbiome unknown.
Thirdly, neonatal nutrition plays a vital role in the two aforementioned processes-because breastfeeding both initiates tropic priming of the newborn gut and transfers numerous immunological factors to the baby. However, few studies have explored the synergy between neonatal microbiome and immunome development, and even fewer through the lens of newborn nutrition. Moreover, virtually zero studies include an integrated characterization of these processes in the SVN. Evidence suggests that, compared to mothers of full-term neonates, the colostrum from mothers of preterm newborns has higher protein and fat content, free amino acids, sodium, and bioactive milk components including HMOs, cytokines, and lactoferrin. But because few studies have evaluated the association between early milk composition and infant growth and development, it is unclear which components are most imperative for a healthy gut microbiota and a robust immune system, particularly in the SVN.
Major advances in systems biology approaches allowing for unbiased, integrated analyses of high-dimensional -omic databases have provided the critical bioinformatic toolkit required to address these questions. Indeed, the ground has never been more fertile for a step-change in commitment to high-impact research on neonatal microbiome and immunome development and the synergy with newborn nutrition.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small Vulnerable Newborns | – | –* Low birth weight: <2500g; and/or, * Preterm: born between the 34th and 37th week of pregnancy; and/or, * Small for Gestational Age: <10 percentile of INTERGROWTH-21st birthweight standards. |
| Healthy Community Controls | – | –* Born after the 37th week of pregnancy; and, * Birth weight ≥2500g; and, * ≥10 percentile of INTERGROWTH-21st birthweight standards. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is composed of all pregnant women at the beginning of the third trimester of their pregnancy attending regular antenatal consultations (ANC) at Accart-Ville, Colma 1 or Farakan health centers.
Key inclusion criteria (19 listed)
- Fundal height between 24 and 27 cm
- Woman living in the health zone of Accart-Ville, Colma 1 or Farakan
- Woman not planning to give birth or move outside the study area in the first 6 months of the infant's life
- Gestational age between 24 weeks 0 completed day and 29 weeks 6 days (ultrasound)
- Monofetal pregnancy without visible malformation
Key exclusion criteria (9 listed)
- Fundal height <24 cm or >27 cm
- Woman living outside the sanitary zone of the Accart-Ville, Colma 1 or Farakan
- Woman planning to give birth outside the study area or to move from it within the first 6 months of the infants's life
- Gestational age <24 weeks or ≥30 weeks (ultrasound)
- Multi-fetal pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differential abundances of bacterial genera in the infant gut microbiota
Time frame: to be assessed at on days 3, 7, 14, 30, 60, 180 of life
Shotgun metagenomic sequencing
4 secondary outcomes
Infant gut microbiota α and β diversity
Time frame: to be assessed at on days 3, 7, 14, 30, 60, 180 of life
Infant plasma immunophenotyping
Time frame: to be assessed at birth and on days 1, 3, 5, 7, 30, 60 of life
Infant plasma chemokine and cytokine analyses
Time frame: to be assessed at birth and on days 1, 3, 5, 7, 30, 60 of life
Maternal breastmilk component* profiling
Time frame: on days 3, 7, 14, 30, 60 of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Background: PubMed 33329546Bennike TB, Fatou B, Angelidou A, Diray-Arce J, Falsafi R, Ford R, Gill EE, van Haren SD, Idoko OT, Lee AH, Ben-Othman R, Pomat WS, Shannon CP, Smolen KK, Tebbutt SJ, Ozonoff A, Richmond PC, van den Biggelaar AHJ, Hancock REW, Kampmann B, Kollmann TR, Levy O, Steen H. Preparing for Life: Plasma Proteome Changes and Immune System Development During the First Week of Human Life. Front Immunol. 2020 Oct 20;11:578505. doi: 10.3389/fimmu.2020.578505. eCollection 2020.
- Background: PubMed 24304052Bhutta ZA, Black RE. Global maternal, newborn, and child health--so near and yet so far. N Engl J Med. 2013 Dec 5;369(23):2226-35. doi: 10.1056/NEJMra1111853. No abstract available.
- Background: PubMed 32284564Bittinger K, Zhao C, Li Y, Ford E, Friedman ES, Ni J, Kulkarni CV, Cai J, Tian Y, Liu Q, Patterson AD, Sarkar D, Chan SHJ, Maranas C, Saha-Shah A, Lund P, Garcia BA, Mattei LM, Gerber JS, Elovitz MA, Kelly A, DeRusso P, Kim D, Hofstaedter CE, Goulian M, Li H, Bushman FD, Zemel BS, Wu GD. Bacterial colonization reprograms the neonatal gut metabolome. Nat Microbiol. 2020 Jun;5(6):838-847. doi: 10.1038/s41564-020-0694-0. Epub 2020 Apr 13.
- Background: PubMed 22513036Bode L. Human milk oligosaccharides: every baby needs a sugar mama. Glycobiology. 2012 Sep;22(9):1147-62. doi: 10.1093/glycob/cws074. Epub 2012 Apr 18.
- Background: PubMed 23778794Chu H, Mazmanian SK. Innate immune recognition of the microbiota promotes host-microbial symbiosis. Nat Immunol. 2013 Jul;14(7):668-75. doi: 10.1038/ni.2635.
- Background: PubMed 23976878Funkhouser LJ, Bordenstein SR. Mom knows best: the universality of maternal microbial transmission. PLoS Biol. 2013;11(8):e1001631. doi: 10.1371/journal.pbio.1001631. Epub 2013 Aug 20.
- Background: PubMed 33245565Granger CL, Embleton ND, Palmer JM, Lamb CA, Berrington JE, Stewart CJ. Maternal breastmilk, infant gut microbiome and the impact on preterm infant health. Acta Paediatr. 2021 Feb;110(2):450-457. doi: 10.1111/apa.15534. Epub 2020 Sep 16.
- Background: PubMed 24033881Jost T, Lacroix C, Braegger CP, Rochat F, Chassard C. Vertical mother-neonate transfer of maternal gut bacteria via breastfeeding. Environ Microbiol. 2014 Sep;16(9):2891-904. doi: 10.1111/1462-2920.12238. Epub 2013 Sep 3.
- Background: PubMed 28329702Kollmann TR, Kampmann B, Mazmanian SK, Marchant A, Levy O. Protecting the Newborn and Young Infant from Infectious Diseases: Lessons from Immune Ontogeny. Immunity. 2017 Mar 21;46(3):350-363. doi: 10.1016/j.immuni.2017.03.009.
- Background: PubMed 30862783Lee AH, Shannon CP, Amenyogbe N, Bennike TB, Diray-Arce J, Idoko OT, Gill EE, Ben-Othman R, Pomat WS, van Haren SD, Cao KL, Cox M, Darboe A, Falsafi R, Ferrari D, Harbeson DJ, He D, Bing C, Hinshaw SJ, Ndure J, Njie-Jobe J, Pettengill MA, Richmond PC, Ford R, Saleu G, Masiria G, Matlam JP, Kirarock W, Roberts E, Malek M, Sanchez-Schmitz G, Singh A, Angelidou A, Smolen KK; EPIC Consortium; Brinkman RR, Ozonoff A, Hancock REW, van den Biggelaar AHJ, Steen H, Tebbutt SJ, Kampmann B, Levy O, Kollmann TR. Dynamic molecular changes during the first week of human life follow a robust developmental trajectory. Nat Commun. 2019 Mar 12;10(1):1092. doi: 10.1038/s41467-019-08794-x.
- Background: PubMed 32978424Ma J, Li Z, Zhang W, Zhang C, Zhang Y, Mei H, Zhuo N, Wang H, Wang L, Wu D. Comparison of gut microbiota in exclusively breast-fed and formula-fed babies: a study of 91 term infants. Sci Rep. 2020 Sep 25;10(1):15792. doi: 10.1038/s41598-020-72635-x.
- Background: PubMed 24244304Makino H, Kushiro A, Ishikawa E, Kubota H, Gawad A, Sakai T, Oishi K, Martin R, Ben-Amor K, Knol J, Tanaka R. Mother-to-infant transmission of intestinal bifidobacterial strains has an impact on the early development of vaginally delivered infant's microbiota. PLoS One. 2013 Nov 14;8(11):e78331. doi: 10.1371/journal.pone.0078331. eCollection 2013.
- Individual participant dataSharing planned: Yes. All the data collected during the DenBalo study will be pseudonymised (i.e., identifable data can still be linked to patient files by means of a code) and the key to the codes will only be accessible to the principal investigators, or his/her representative. The collected pseudonymised data as well as the collected biological samples can be shared with other (future) researchers for future research projects and studies, exclusively in the context of the same disease/pathology or similar (i.e., in the interest of research on maternal, newborn and child health). This will be done within a strictly legal framework and in compliance with international laws on the protection of personal data. Only anonymized data will be used in any type of documentation, reports or publications (in the medical scientific literature and/or at medical conferences). Personal patient data will be stored for at least 25 years after the end of the study.
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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.
Trenton Dailey-Chwalibóg, MPH, PhD principal investigator
University Ghent
Carl Lachat, MEng, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Low Birth Weight, run by University Ghent at 1 site in Burkina Faso.
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 19 inclusion and 9 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 31 May 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 Burkina Faso. 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 Trenton Dailey-Chwalibóg, MPH, PhD (+33603233614, Trenton@Dailey-Chwalibog.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential abundances of bacterial genera in the infant gut microbiota (time frame: to be assessed at on days 3, 7, 14, 30, 60, 180 of life). 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 NCT05730569, which also lists 17 linked publications.
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 31 May 2024.