Trials Sponsors Conditions Drugs Pricing

Conditions

Critical Illness Dysbiosis Pediatric ALL

Keywords

microbiomegastrointestinal microbiomepediatricscritical illness

Outcome Measures

Primary Outcomes (2)

Changes to the gastrointestinal microbiome
Fecal samples will be collected for bacterial 16s rRNA gene sequencing and analysis
Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings
Changes to the gastrointestinal microbiome
Salivary samples will be collected for bacterial 16s rRNA gene sequencing and analysis
Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings

Secondary Outcomes (1)

Concentration of short-chain fatty acids
Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings

Study Arms (2)

Pediasure

ACTIVE COMPARATOR

Patients assigned to this arm will receive Pediasure

Other: Pediasure

Nourish

ACTIVE COMPARATOR

Patients assigned to this arm will receive Nourish

Other: Nourish

Interventions

NourishOther

The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome

Nourish

PediasureOther

The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome

Pediasure

Eligibility Criteria

Age1 Year - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Admitted to the pediatric intensive care unit
Age 1-17 years old

Sponsors & Collaborators

University of Pittsburgh
Otherlead

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

MeSH Terms

Conditions

Critical IllnessDysbiosisPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative Disorders

Study Officials

Raj Aneja, MD
University of Pittsburgh Medical Center
PRINCIPAL INVESTIGATOR

Enrollment

32 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor

Study Record Dates

First Submitted

January 22, 2018

First Posted

January 30, 2018

Influences of High-fiber, Organic Whole-food Formula on the Gut Microbiome in Critically Ill Children

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Pediasure

Nourish

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Pediasure

Nourish

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations