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Milk in Life Conditions (MiLC): Bacterial Composition of Human Milk Pumped and Stored in "Real-Life" Conditions (MiLC)

30 aprile 2019 aggiornato da: Cornell University

Milk in Life Conditions (MiLC): Characterizing the Bacterial Composition of Human Milk Pumped and Stored in "Real-life" Conditions

The MiLC trial is a randomized control trial of two different breast pump set-ups: mother's own and sterile. The objective of this trial is to investigate the bacterial composition of human milk pumped and stored in "real-life" conditions. To meet this objective, lactating mothers will fully express breast milk from one breast on two consecutive pumping sessions at home, once with the participant's own pumps and collection kits (own pump set-up) and once with a hospital-grade pump and disposable, sterile collection kits (sterile pump set-up). Randomization will be used to determine which pump participants use first. From the total volume of milk pumped during each pumping session, the researchers will collect 1 oz. Milk from both pumps will be stored at home and sampled on days 0, 2, 4, and 30 after expression for analysis of its bacterial composition.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Participants will donate 1 oz of human milk during each of two consecutive pumping sessions, for a total volume of 2 oz donated on one day. To collect this human milk, participants will be asked to fully express one breast during each pumping session. Participants will pump once with the participant's own pump set-up and once with the sterile pump set-up (provided by the research team). Women will be randomized to which pump is used first.

Randomization will be done using stratified randomization as follows: participants were stratified by how their infants were fed, namely whether infants were fed human milk only vs. human milk and complementary foods). Then, randomization was conducted within each strata. The researchers aim to have a minimum of 25 participants in each stratum.

All human milk collections will occur at participants' homes between 0700 and 1100 hours. The second pumping session must begin 3 hours (+/-30 minutes) after the beginning of the first pumping session (e.g. the first pumping session at 7:30 am and the second at 10:30 am). Participants will elect from which breast to donate human milk and that breast will be used for both pumping sessions. Participants will be asked not to nurse from or pump that breast during the 2 hours before the first pumping session and not until after the second pumping session (a total of ~5.5 hours).

From the milk produced during each pumping session (which could be up to ~6 oz), researchers will collect 1 oz using a sterile, plastic syringe. Participants will keep the remaining volume of milk. Each ounce of milk collected will be separated into 5 sterile containers (provided). Participants will store donated milk at home until it is picked up by a researcher 2, 4, and 30 days after pumping.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

52

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • New York
      • Ithaca, New York, Stati Uniti, 14853
        • Hay Laboratory, B75C Wing Hall, Cornell University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • Lactating women over the age of 18 years
  • Self-reported as healthy women and infants
  • Use an electric breast pump
  • Confident of ability to donate 1 oz of milk from one breast during each of two consecutive pumping sessions where pumping sessions are 3 hours (+/- 30 minutes) apart and between 0700-1100 hours.
  • Able to store donated milk at home for 30 days
  • Have infants who do not consume formula or only consume formula episodically as long as the most recent formula-feeding occurred > 2 weeks before the day milk is pumped for this study.

Exclusion Criteria:

  • Not confident of ability to donate 1 oz of milk from one breast during each of two consecutive pumping sessions, 3 hours (+/- 30 minutes) apart and between the hours of 0700-1100 hours.
  • Infant consumption of formula in the past 2 weeks
  • Current indication of breast infection (e.g., breast pain, discomfort, lumps, mastitis with fever, red streaks, or hard red portions of the breast)
  • Breast pain that the woman does not consider "normal" for lactation/breastfeeding
  • Signs/symptoms of acute illness in woman or infant in past 7 days including fever (rectal or temporal temperature ≥99.5 F), dark green nasal discharge, diarrhea (abrupt onset of 3 or more excessively "loose" stools in one day), vomiting (where infant vomiting is not associated with feeding), or severe cough.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Sterile pump set-up first
Participants will pump with sterile pump set-ups first. Approximately 3 hours later, participants will pump with their own pump set-ups.
Dispositivo: Sterile pump set-up
Medela symphony breast pump (model number 0240108) and disposable, sterile collection kits (model number 67399S).
Dispositivo: Mother's Own pump set-up
Mother's own electric breast pump and own collection kit (previously used and cleaned at home using her usual practices).
Sperimentale: Mother's Own pump set-up first
Participants will pump with their own pump set-ups first. Approximately 3 hours later, participants will pump with sterile pump set-ups.
Dispositivo: Sterile pump set-up
Medela symphony breast pump (model number 0240108) and disposable, sterile collection kits (model number 67399S).
Dispositivo: Mother's Own pump set-up
Mother's own electric breast pump and own collection kit (previously used and cleaned at home using her usual practices).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Bacterial Community Richness
Lasso di tempo: 0 days after pumping
Richness is the total number of different bacterial taxa detected in the sample. This metric will be assessed on data collected via high-throughput sequencing of the bacterial 16S rRNA gene present in milk.
0 days after pumping
Bacterial Community Diversity
Lasso di tempo: 0 days after pumping
Bacterial community diversity will be assessed using the the Shannon diversity index. The Shannon diversity index is a type of entropy measure and is a function of the distribution of the total number of organisms across all of the species. If S is the total number of species in the sample and p_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = -Σ p_i log(p_i). This metric will be assessed on data collected via high-throughput sequencing of the bacterial 16S rRNA gene present in milk.
0 days after pumping
Total Live Aerobic Bacterial Counts
Lasso di tempo: 0 days after pumping
Number of live total aerobic bacteria in milk assessed by aerobic culturing of milk on plate count agar. Reported as colony-forming units (CFU)/mL.
0 days after pumping

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Cornell University

Collaboratori

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
United States Department of Agriculture (USDA)
University of Idaho

Investigatori

  • Investigatore principale: Kathleen M. Rasmussen, ScD, Cornell University
  • Investigatore principale: Anthony Hay, PhD, Cornell University
  • Direttore dello studio: Sarah Reyes, MS, Cornell University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

22 maggio 2017

Completamento primario (Effettivo)

2 ottobre 2017

Completamento dello studio (Effettivo)

2 ottobre 2017

Date di iscrizione allo studio

Primo inviato

6 aprile 2017

Primo inviato che soddisfa i criteri di controllo qualità

17 aprile 2017

Primo Inserito (Effettivo)

21 aprile 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 maggio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 aprile 2019

Ultimo verificato

1 aprile 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB #: 1608006566
  • 2T32DK007158-42 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NYC-399436 (Altro numero di sovvenzione/finanziamento: NIFA/USDA)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

The researchers are currently undecided about how all the data from the study will be released but 16S rRNA data will be released through INSDC (the International Nucleotide Sequence Database Collaboration, which encompasses NCBI, EBI and DDBJ).

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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