Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
NCT Number: NCT03414775
This study evaluates the effects of either Pediasure or Nourish formulas on the gastrointestinal microbiome in critically-ill children. Patients will be randomized to received either Pediasure or Nourish.
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Notify Me1 year–17 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15224, United States
The gastrointestinal microbiome has been shown to be altered in critically-ill children such that there is a larger shift toward pathogenic bacteria. Previous studies have shown that probiotics, fecal transplants, antibiotic decontamination, and dietary interventions can shift the gastrointestinal microbiome toward a metabolically favorable microbiome profile and be associated with improvements in disease burden.
This study will randomize critically-ill children who are stable enough for enteral tube feedings to receive either Pediasure or Nourish. Pediasure is a commercially-made formula that is used commonly in pediatric patients. Nourish is an organic, whole-food formula with a high fiber content. High-fiber diets have been correlated with metabolically favorable microbiome profiles. This study will look at the microbiome before and after initiation of enteral tube feedings to determine if either formula is associated with a shift in the microbiome toward a favorable profile.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome
The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome
Time frame: Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings
Fecal samples will be collected for bacterial 16s rRNA gene sequencing and analysis
Time frame: Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings
Salivary samples will be collected for bacterial 16s rRNA gene sequencing and analysis
Time frame: Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings
Fecal samples will be analyzed by gas chromatography
University of Pittsburgh
Other
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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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