Microbial ColonizationAMAMINCT04122612
Shaping Microbiome in the First 1,000 Days of Life
An observational study of Microbial Colonization, run by University of Pavia at 1 site in Italy.
Trial summary
Events occurring in the early stages of life play an important role in the development of chronic diseases; diet and lifestyle during pregnancy are recognized to be crucial determinants in modulating offspring microbiota, throughout a vertical transfer of dysbiotic maternal ambient. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 23 Sep 2018to 7 Oct 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 60 dyads (mother/new-born) attending the Neonatal Unit, Fondazione IRCCS Policlinico San Matteo, Pavia (Italy)
Who may be able to join
- Infants of both sexes born to natural or caesarean delivery;
- Gestational age between 35 and 42 completed weeks;
- Italian-speaking parents;
- Ability of the parent/guardian to give informed consent;
- Ability of the mother to respond to the structured interview/questionnaires;
Who cannot join
- Children or mothers with genetic/congenital diseases;
- Children hospitalized immediately after birth;
- Children selected for other clinical studies;
- Presence of gestational diabetes;
- Presence of hyperthyroidism during pregnancy;
- Parents refusing to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prenatal and Postnatal Determinants in Shaping Offspring's Microbiota in the First Year of Life: A Study Protocol
Events occurring in the early stages of life play an important role in the development of chronic diseases; diet and lifestyle during pregnancy are recognized to be crucial determinants in modulating offspring microbiota, throughout a vertical transfer of dysbiotic maternal ambient. Moreover, the intestinal colonization is maximized in the first two years of life through newborn's type and time of feeding. This study will provide the starting point for a future prospective observational study to assessing the association between maternal lifestyle with infant microbiota and their influence future health.
Read the detailed description
Evidence from the Developmental Origins of Health and Disease (DOHaD) theory has pointed out biological mechanisms supporting the intergenerational nature of non communicable diseases (NCDs), which are an increasing public health problem in many countries. Furthermore, scientific evidence confirms that the events occurring in the early stages of life play a critical role in fostering the development of chronic diseases (e.g. overweight and obesity, allergies, cardiovascular and metabolic diseases, neurocognitive impairment and cancers), throughout the life-course, indicating the high relevance of "the maternal environment" impact on the life of the future child. This crucial window goes from the conception to the two years of life, and it is known as 'first thousand days'.
Nutritional status during pregnancy is one of the crucial determinants in modulating the characteristics of the "maternal environment" in which the foetus originates and develops. Therefore, adequate nutrition just before conception, during pregnancy, infancy and early childhood is essential to ensure growth, health, and development of children to their full potential.
Epigenetic links have been confirmed in mice between the prenatal diet and the increased incidence of obesity, type 2 diabetes and other metabolic associated conditions in their offspring. However, specific epigenetic regulation mechanisms are still unclear. Recently, an increasing number of animal and human studies have proposed the hypothesis that the gut microbiota may be considered an important mediator of vital microbiome-host interaction(s) under health or disease conditions. Moreover, microbiota has been shown to pass features from one generation to the next via maternal contact; in fact, recent observation of microbial presence in placenta, meconium and amniotic fluid has suggested a significant interplay between the environmental microbes and the developing gastrointestinal tract of the fetus even before delivery. Thus, the alteration of microbiota composition, driving to increased long-term susceptibility to diseases, can begin early in life.
Examination of the neonatal gut microbiome immediately after delivery revealed that it varied by virtue of maternal gestational diet suggesting that the colonization of the infant gut is likely to occur prior to parturition.
During the first months after birth, the bacterial flora in the gut is known to be affected by many factors, including mode of delivery, use of antibiotics or probiotics, geographical location, type and time of feeding.
Moreover, maternal exposures during pregnancy to several environmental chemicals are known to induce perturbations in the composition of the gastrointestinal microbiome. Among these substances, endocrine disruptor chemicals (EDCs), such as phthalates, bisphenol and hydroxypyrene, which can be found in oil and water resistant textile coatings, non-stick cookware, food container coatings, floor polish, fire-fighting foam, and industrial surfactants, are a class of suspected obesogenic contaminants persisting in the environment and humans. EDCs have been also detected in cord blood samples, suggesting that exposure starts prenatally and early life EDC exposures may perturb neuroendocrine systems involved in growth, energy metabolism, appetite, adipogenesis, and glucose-insulin homeostasis promoting childhood obesity development.
After this first period, the gut microbial composition continues to evolve until the age of 2-3 years; these first years represent as "a window of opportunity" for microbial modulation, influenced by complementary feeding period, gradual transition from milk-based infant feeding to weaning and solid foods, usually occurring between 6 and 24 months.
A.MA.MI is a longitudinal, prospective, observational study that includes a group of mother-infant pairs (n=60) attending the Neonatal Unit, Fondazione IRCCS Policlinico San Matteo, Pavia (Italy). The study was planned to provide data collected before discharge (T0) and at 1,6,12 months after birth (T1,T2,T3). Maternal and infant anthropometric measurements are assessed at each time. Other variables evaluated are pre-pregnancy/gestational weight status (T0), maternal dietary habits/physical activity (T1-T3); infant medical history, type of feeding, antibiotics/probiotics/supplements use, environment exposures (e.g cigarette smoking, pets, environmental temperature) (T1-T3). A child stool sample was planned to be collected at each time and analyzed using metagenomics 16S ribosomal RNA gene sequence-based methods. Maternal urine samples were planned to be collected at T3 to investigate pollutants exposure (Phthalates, Bisphenol A and Hydroxypyrene).
Since there are still limited knowledge about the child's microbiota, its changes over time and the host and environmental interactions in shaping its composition, further prospective studies are needed to determine how different factors related to diet-related factors, lifestyle, drugs and anthropometric measures can influence microbial colonization of the gut during early childhood and influence the future health status.
- Conditions
- Microbial Colonization
- Keywords
- microbiota, 1000 days, maternal lifestyle, diet, pregnancy
- Medical subject headings
- Communicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intestinal microbiota composition from 0 to 12 months of life
Investigate the intestinal microbiota development of infants at 0, 1, 6, 12 months after birth by:
- Identifying the relative abundance of the dominant organism genera; ii) Assessing the microbial diversity (α-diversity); iii) Assessing inter-individual variation (β-diversity).
Measured: 0 months (2-3 days after birth); 1 months after birth; 6 months after birth; 12 months after birth.
Secondary outcomes (1)
examine the association of maternal and infants factor and the intestinal microbiota development of infants.
exploring the possible correlation between maternal factors before pregnancy (weight status), gestational exposures (maternal diet, physical activity, weight status, EDCs), mode of delivery, lactation (formula or breastfeeding), family environment exposure, infant diet, sleeping habits and infant intestinal microbiota composition, during the first year of life at different follow-up:
- immediately after the delivery (not more than 2-3 days after the delivery, T0);
- 1 month after birth (T1);
- 6 months after birth (T2);
- 12 months after birth (T3).
Measured: 0 months (2-3 days after birth); 1 months after birth; 6 months after birth; 12 months after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start23 Sep 2018
- Primary completion7 Oct 2019
- Study completion7 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia, Istituti Clinici Scientifici Maugeri SpA, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Responsible party
- Principal investigator, Hellas Cena, University of Pavia
- Investigators
- Hellas Cena, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122612
- Sponsor's protocol ID
- 20191004
- Acronym
- AMAMI
- Status last verified
- Oct 2019
- First submitted
- 7 Oct 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vacca M, Raspini B, Calabrese FM, Porri D, De Giuseppe R, Chieppa M, Liso M, Cerbo RM, Civardi E, Garofoli F, Cena H, De Angelis M. The establishment of the gut microbiota in 1-year-aged infants: from birth to family food. Eur J Nutr. 2022 Aug;61(5):2517-2530. doi: 10.1007/s00394-022-02822-1. Epub 2022 Feb 25.
PubMed 35211851Raspini B, Porri D, De Giuseppe R, Chieppa M, Liso M, Cerbo RM, Civardi E, Garofoli F, Monti MC, Vacca M, De Angelis M, Cena H. Prenatal and postnatal determinants in shaping offspring's microbiome in the first 1000 days: study protocol and preliminary results at one month of life. Ital J Pediatr. 2020 Apr 15;46(1):45. doi: 10.1186/s13052-020-0794-8.
PubMed 32293504
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal and Postnatal Determinants in Shaping Offspring's Microbiota in the First Year of Life: A Study Protocol
- ClinicalTrials.gov ID
- NCT04122612
- Acronym / sponsor ID
- AMAMI / 20191004
- Conditions
- Microbial Colonization
- Keywords
- microbiota, 1000 days, maternal lifestyle, diet, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia, Istituti Clinici Scientifici Maugeri SpA, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Study start
- 23 Sep 2018 (actual)
- Primary completion
- 7 Oct 2019 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 10 Oct 2019 (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.
Events occurring in the early stages of life play an important role in the development of chronic diseases; diet and lifestyle during pregnancy are recognized to be crucial determinants in modulating offspring microbiota, throughout a vertical transfer of dysbiotic maternal ambient. Moreover, the intestinal colonization is maximized in the first two years of life through newborn's type and time of feeding. This study will provide the starting point for a future prospective observational study to assessing the association between maternal lifestyle with infant microbiota and their influence future health.
Detailed description
Evidence from the Developmental Origins of Health and Disease (DOHaD) theory has pointed out biological mechanisms supporting the intergenerational nature of non communicable diseases (NCDs), which are an increasing public health problem in many countries. Furthermore, scientific evidence confirms that the events occurring in the early stages of life play a critical role in fostering the development of chronic diseases (e.g. overweight and obesity, allergies, cardiovascular and metabolic diseases, neurocognitive impairment and cancers), throughout the life-course, indicating the high relevance of "the maternal environment" impact on the life of the future child. This crucial window goes from the conception to the two years of life, and it is known as 'first thousand days'.
Nutritional status during pregnancy is one of the crucial determinants in modulating the characteristics of the "maternal environment" in which the foetus originates and develops. Therefore, adequate nutrition just before conception, during pregnancy, infancy and early childhood is essential to ensure growth, health, and development of children to their full potential.
Epigenetic links have been confirmed in mice between the prenatal diet and the increased incidence of obesity, type 2 diabetes and other metabolic associated conditions in their offspring. However, specific epigenetic regulation mechanisms are still unclear. Recently, an increasing number of animal and human studies have proposed the hypothesis that the gut microbiota may be considered an important mediator of vital microbiome-host interaction(s) under health or disease conditions. Moreover, microbiota has been shown to pass features from one generation to the next via maternal contact; in fact, recent observation of microbial presence in placenta, meconium and amniotic fluid has suggested a significant interplay between the environmental microbes and the developing gastrointestinal tract of the fetus even before delivery. Thus, the alteration of microbiota composition, driving to increased long-term susceptibility to diseases, can begin early in life.
Examination of the neonatal gut microbiome immediately after delivery revealed that it varied by virtue of maternal gestational diet suggesting that the colonization of the infant gut is likely to occur prior to parturition.
During the first months after birth, the bacterial flora in the gut is known to be affected by many factors, including mode of delivery, use of antibiotics or probiotics, geographical location, type and time of feeding.
Moreover, maternal exposures during pregnancy to several environmental chemicals are known to induce perturbations in the composition of the gastrointestinal microbiome. Among these substances, endocrine disruptor chemicals (EDCs), such as phthalates, bisphenol and hydroxypyrene, which can be found in oil and water resistant textile coatings, non-stick cookware, food container coatings, floor polish, fire-fighting foam, and industrial surfactants, are a class of suspected obesogenic contaminants persisting in the environment and humans. EDCs have been also detected in cord blood samples, suggesting that exposure starts prenatally and early life EDC exposures may perturb neuroendocrine systems involved in growth, energy metabolism, appetite, adipogenesis, and glucose-insulin homeostasis promoting childhood obesity development.
After this first period, the gut microbial composition continues to evolve until the age of 2-3 years; these first years represent as "a window of opportunity" for microbial modulation, influenced by complementary feeding period, gradual transition from milk-based infant feeding to weaning and solid foods, usually occurring between 6 and 24 months.
A.MA.MI is a longitudinal, prospective, observational study that includes a group of mother-infant pairs (n=60) attending the Neonatal Unit, Fondazione IRCCS Policlinico San Matteo, Pavia (Italy). The study was planned to provide data collected before discharge (T0) and at 1,6,12 months after birth (T1,T2,T3). Maternal and infant anthropometric measurements are assessed at each time. Other variables evaluated are pre-pregnancy/gestational weight status (T0), maternal dietary habits/physical activity (T1-T3); infant medical history, type of feeding, antibiotics/probiotics/supplements use, environment exposures (e.g cigarette smoking, pets, environmental temperature) (T1-T3). A child stool sample was planned to be collected at each time and analyzed using metagenomics 16S ribosomal RNA gene sequence-based methods. Maternal urine samples were planned to be collected at T3 to investigate pollutants exposure (Phthalates, Bisphenol A and Hydroxypyrene).
Since there are still limited knowledge about the child's microbiota, its changes over time and the host and environmental interactions in shaping its composition, further prospective studies are needed to determine how different factors related to diet-related factors, lifestyle, drugs and anthropometric measures can influence microbial colonization of the gut during early childhood and influence the future health status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 60 dyads (mother/new-born) attending the Neonatal Unit, Fondazione IRCCS Policlinico San Matteo, Pavia (Italy)
Key inclusion criteria (5 listed)
- Infants of both sexes born to natural or caesarean delivery;
- Gestational age between 35 and 42 completed weeks;
- Italian-speaking parents;
- Ability of the parent/guardian to give informed consent;
- Ability of the mother to respond to the structured interview/questionnaires;
Key exclusion criteria (6 listed)
- Children or mothers with genetic/congenital diseases;
- Children hospitalized immediately after birth;
- Children selected for other clinical studies;
- Presence of gestational diabetes;
- Presence of hyperthyroidism during 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
Change in intestinal microbiota composition from 0 to 12 months of life
Time frame: 0 months (2-3 days after birth); 1 months after birth; 6 months after birth; 12 months after birth.
Investigate the intestinal microbiota development of infants at 0, 1, 6, 12 months after birth by: i) Identifying the relative abundance of the dominant organism genera; ii) Assessing the microbial diversity (α-diversity); iii) Assessing inter-individual variation (β-diversity).
1 secondary outcome
examine the association of maternal and infants factor and the intestinal microbiota development of infants.
Time frame: 0 months (2-3 days after birth); 1 months after birth; 6 months after birth; 12 months after birth.
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 10 Oct 2019.
- Derived from this study: PubMed 35211851Vacca M, Raspini B, Calabrese FM, Porri D, De Giuseppe R, Chieppa M, Liso M, Cerbo RM, Civardi E, Garofoli F, Cena H, De Angelis M. The establishment of the gut microbiota in 1-year-aged infants: from birth to family food. Eur J Nutr. 2022 Aug;61(5):2517-2530. doi: 10.1007/s00394-022-02822-1. Epub 2022 Feb 25.
- Derived from this study: PubMed 32293504Raspini B, Porri D, De Giuseppe R, Chieppa M, Liso M, Cerbo RM, Civardi E, Garofoli F, Monti MC, Vacca M, De Angelis M, Cena H. Prenatal and postnatal determinants in shaping offspring's microbiome in the first 1000 days: study protocol and preliminary results at one month of life. Ital J Pediatr. 2020 Apr 15;46(1):45. doi: 10.1186/s13052-020-0794-8.
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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.
Hellas Cena principal investigator
University of Pavia
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 Microbial Colonization, run by University of Pavia at 1 site in Italy.
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 5 inclusion and 6 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 10 Oct 2019. 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 Italy. 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?
Change in intestinal microbiota composition from 0 to 12 months of life (time frame: 0 months (2-3 days after birth); 1 months after birth; 6 months after birth; 12 months after birth.). 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 NCT04122612, which also lists 2 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 10 Oct 2019.