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NCT Number: NCT02738411

Influence of Intestinal Microbiota Implantation in Preterm Infants on Microbiota and Immune Orientation at 3 Years

The main objective of this research is to study the links between changes in the intestinal microbiota (in terms of diversity) during the first 6 weeks of life for preterm infants and the presence / absence of a TH1 immune status at 36 months of age.

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Key information

Conditions

Infant, Premature Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 1 day

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Montpellier - Hôpital Arnaud de Villeneuve, Montpellier, France

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About this study

The secondary objectives are to study the links between changes of the intestinal microbiota premature infants in terms of:

  • changing diversity of the microbiota in the first 6 weeks of life;
  • changes in the bacterial community (UniFrac study) during the first 6 weeks of life;
  • diversity of the microbiota up to 6 weeks;

-AND-

  • diversity of the microbiota at 1, 2 & 3 years;
  • bacterial communities (UniFrac study) at 1, 2 & 3 years;
  • lymphocyte subpopulation profiles at 3 years;
  • serum immunoglobulin A, G, M, E levels at 3 years;
  • history of infectious episodes, allergic and inflammatory episodes during the first 3 years of life.

The links between certain variables known in the literature and neonatal microbiota will be confirmed / studied in our population:

  • mode of delivery;
  • length (and type) of antibiotic therapy in the neonatal period;
  • duration of breastfeeding.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The parents of the patient (or legal guardian if any) have been informed about the implementation of the study, its objectives, its constraints, and patient rights
  • The parents of the patient (or legal guardian if any) must have given their free and informed consent and signed the consent form
  • The patient must be affiliated with or beneficiary of a health insurance plan
  • Premature infants born at less than 33 weeks of gestation

Exclusion criteria

  • The patient is participating in another interventional study (Excepted " Recherche du Portage de Clostridium butyricum et de Toxines de Clostridium chez les Prématurés Hospitalisés en Néonatologie afin de prédire la survenue d'Entérocolites Nécrosantes", RCB 2016-A00-529-42 ; " BetaDose Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth ", RCB 2016-001486-90.
  • It is not possible to correctly inform the parent (or legal guardian, if applicable)
  • A serious deformity or digestive malformation was diagnosed at birth
  • During the hospital stay in the neonatology department, the patient had a digestive disease requiring surgery (except necrotizing enterocolitis)
  • A transfer to another hospital is foreseen/predictable (eg, due to geographical distance)

Treatment and study plan

Primary outcomes

  1. The presence/absence of a Th1 type immune orientation

    Time frame: 36 months

    Immune orientation will be determined according to the following ratio determined by lymphocyte stimulation tests: INF-gamma/(INF-gamma+IL+4). The latter ratio varies between 0 and 0.5 with IL-4 > INF-gamma (TH2 orientation) and between 0.5 and 1 when INF-gamma > IL-4 (TH1 orientation).

Secondary outcomes

  1. Blood lymphocyte subset determination

    Time frame: 36 months

    Subsets are determined according to the presence/absence of the following differentiation clusters: CD3, CD4, CD8, CD19, CD25, CD56, CD127, FOXP3.

Other outcomes

  1. Serum Immunoglobulin A level

    Time frame: 36 months

  2. Serum Immunoglobulin G level

    Time frame: 36 months

  3. Serum Immunoglobulin M level

    Time frame: 36 months

  4. Serum Immunoglobulin E level

    Time frame: 36 months

  5. The number of days in good health and no medications

    Time frame: 36 months

  6. Richness of fecal microbiota (number of operational taxonomic units observed)

    Time frame: Day 0 (first meconium)

  7. Richness of fecal microbiota (number of operational taxonomic units observed)

    Time frame: Week 1

  8. Richness of fecal microbiota (number of operational taxonomic units observed)

    Time frame: Week 2

  9. Richness of fecal microbiota (number of operational taxonomic units observed)

    Time frame: Week 3

  10. Richness of fecal microbiota (number of operational taxonomic units observed)

    Time frame: Week 4

  11. Richness of fecal microbiota (number of operational taxonomic units observed)

    Time frame: Week 5

  12. Richness of fecal microbiota (number of operational taxonomic units observed)

    Time frame: Week 6

  13. Richness of fecal microbiota (number of operational taxonomic units observed)

    Time frame: 12 months

  14. Richness of fecal microbiota (number of operational taxonomic units observed)

    Time frame: 24 months

  15. Richness of fecal microbiota (number of operational taxonomic units observed)

    Time frame: 36 months

  16. Diversity of fecal microbiota (Shannon's index)

    Time frame: Day 0 (first meconium)

  17. Diversity of fecal microbiota (Shannon's index)

    Time frame: Week 1

  18. Diversity of fecal microbiota (Shannon's index)

    Time frame: Week 2

  19. Diversity of fecal microbiota (Shannon's index)

    Time frame: Week 3

  20. Diversity of fecal microbiota (Shannon's index)

    Time frame: Week 4

  21. Diversity of fecal microbiota (Shannon's index)

    Time frame: Week 5

  22. Diversity of fecal microbiota (Shannon's index)

    Time frame: Week 6

  23. Diversity of fecal microbiota (Shannon's index)

    Time frame: 12 months

  24. Diversity of fecal microbiota (Shannon's index)

    Time frame: 24 months

  25. Diversity of fecal microbiota (Shannon's index)

    Time frame: 36 months

  26. Functional richness of fecal microbiota (number of functional groups observed)

    Time frame: Day 0 (first meconium)

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  27. Functional richness of fecal microbiota (number of functional groups observed)

    Time frame: Week 1

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  28. Functional richness of fecal microbiota (number of functional groups observed)

    Time frame: Week 2

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  29. Functional richness of fecal microbiota (number of functional groups observed)

    Time frame: Week 3

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  30. Functional richness of fecal microbiota (number of functional groups observed)

    Time frame: Week 4

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  31. Functional richness of fecal microbiota (number of functional groups observed)

    Time frame: Week 5

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  32. Functional richness of fecal microbiota (number of functional groups observed)

    Time frame: Week 6

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  33. Functional richness of fecal microbiota (number of functional groups observed)

    Time frame: 12 months

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  34. Functional richness of fecal microbiota (number of functional groups observed)

    Time frame: 24 months

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  35. Functional richness of fecal microbiota (number of functional groups observed)

    Time frame: 36 months

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  36. Functional diversity of fecal microbiota (Shannon's index)

    Time frame: Day 0 (first meconium)

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  37. Functional diversity of fecal microbiota (Shannon's index)

    Time frame: Week 1

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  38. Functional diversity of fecal microbiota (Shannon's index)

    Time frame: Week 2

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  39. Functional diversity of fecal microbiota (Shannon's index)

    Time frame: Week 3

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  40. Functional diversity of fecal microbiota (Shannon's index)

    Time frame: Week 4

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  41. Functional diversity of fecal microbiota (Shannon's index)

    Time frame: Week 5

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  42. Functional diversity of fecal microbiota (Shannon's index)

    Time frame: Week 6

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  43. Functional diversity of fecal microbiota (Shannon's index)

    Time frame: 12 months

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  44. Functional diversity of fecal microbiota (Shannon's index)

    Time frame: 24 months

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  45. Functional diversity of fecal microbiota (Shannon's index)

    Time frame: 36 months

    Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.

  46. The relative abundance of primary fecal microbiota families

    Time frame: Day 0 (first meconium)

  47. The relative abundance of primary fecal microbiota families

    Time frame: Week 1

  48. The relative abundance of primary fecal microbiota families

    Time frame: Week 2

  49. The relative abundance of primary fecal microbiota families

    Time frame: Week 3

  50. The relative abundance of primary fecal microbiota families

    Time frame: Week 4

  51. The relative abundance of primary fecal microbiota families

    Time frame: Week 5

  52. The relative abundance of primary fecal microbiota families

    Time frame: Week 6

  53. The relative abundance of primary fecal microbiota families

    Time frame: 12 months

  54. The relative abundance of primary fecal microbiota families

    Time frame: 24 months

  55. The relative abundance of primary fecal microbiota families

    Time frame: 36 months

  56. Fecal microbiota unifrac ordination score

    Time frame: Day 0 (first meconium)

  57. Fecal microbiota unifrac ordination score

    Time frame: Week 1

  58. Fecal microbiota unifrac ordination score

    Time frame: Week 2

  59. Fecal microbiota unifrac ordination score

    Time frame: Week 3

  60. Fecal microbiota unifrac ordination score

    Time frame: Week 4

  61. Fecal microbiota unifrac ordination score

    Time frame: Week 5

  62. Fecal microbiota unifrac ordination score

    Time frame: Week 6

  63. Fecal microbiota unifrac ordination score

    Time frame: 12 months

  64. Fecal microbiota unifrac ordination score

    Time frame: 24 months

  65. Fecal microbiota unifrac ordination score

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Influence of Intestinal Microbiota Implantation Parameters in the Neonatal Period in Premature Infants on Microbiota Profiles and Immune Orientation at 3 Years of Age

Acronym: PrimiBiota

Important dates

Study start
2017
Primary completion
2022
Study completion
2025
First posted
Apr 14, 2016
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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