Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

30 april 2019 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

52

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • New York
      • Ithaca, New York, Förenta staterna, 14853
        • Hay Laboratory, B75C Wing Hall, Cornell University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Enhet: Sterile pump set-up
Medela symphony breast pump (model number 0240108) and disposable, sterile collection kits (model number 67399S).
Enhet: 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).
Experimentell: 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.
Enhet: Sterile pump set-up
Medela symphony breast pump (model number 0240108) and disposable, sterile collection kits (model number 67399S).
Enhet: 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).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Bacterial Community Richness
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Cornell University

Samarbetspartners

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

Utredare

  • Huvudutredare: Kathleen M. Rasmussen, ScD, Cornell University
  • Huvudutredare: Anthony Hay, PhD, Cornell University
  • Studierektor: Sarah Reyes, MS, Cornell University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

22 maj 2017

Primärt slutförande (Faktisk)

2 oktober 2017

Avslutad studie (Faktisk)

2 oktober 2017

Studieregistreringsdatum

Först inskickad

6 april 2017

Först inskickad som uppfyllde QC-kriterierna

17 april 2017

Första postat (Faktisk)

21 april 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 maj 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 april 2019

Senast verifierad

1 april 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB #: 1608006566
  • 2T32DK007158-42 (U.S.S. NIH-anslag/kontrakt)
  • NYC-399436 (Annat bidrag/finansieringsnummer: NIFA/USDA)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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).

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Bakteriell tillväxt

Kliniska prövningar på Sterile pump set-up

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Azerbaijan

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

Prenumerera