Critical IllnessNCT03414775
Influences of High-fiber, Organic Whole-food Formula on the Gut Microbiome in Critically Ill Children
A study testing Nourish and Pediasure in people with Critical Illness and Dysbiosis, run by University of Pittsburgh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Critical Illness, Dysbiosis, Pediatric ALL
- What is being tested?
- Nourish and Pediasure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2018to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admitted to the pediatric intensive care unit
- Age 1-17 years old
- Previously placed enteric tube designed for enteric feeding
Who cannot join
- Vasoactive medication use
- History of allergies or intolerances to either Pediasure or Nourish
- Whey allergy or intolerance
- Gluten sensitivity or intolerance
- Medical condition that necessitate the use of specific formulas and/or nutritional needs (e.g. epilepsy requiring ketogenic diet, genetic metabolic dysfunction with specific formula requirements)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
About this study
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.
Read the detailed description
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.
- Conditions
- Critical Illness, Dysbiosis, Pediatric ALL
- Being tested
- Nourish, Pediasure
- Keywords
- microbiome, gastrointestinal microbiome, pediatrics, critical illness
- Medical subject headings
- Critical Illness, Dysbiosis, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NourishOther
The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome
PediasureOther
The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome
| Study group | Role | What they receive |
|---|---|---|
| Pediasure | Active comparator | Patients assigned to this arm will receive Pediasure Receives: Other: Pediasure |
| Nourish | Active comparator | Patients assigned to this arm will receive Nourish Receives: Other: Nourish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes to the gastrointestinal microbiome
Fecal samples will be collected for bacterial 16s rRNA gene sequencing and analysis
Measured: 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
Measured: 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
Fecal samples will be analyzed by gas chromatography
Measured: Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start2 Feb 2018
- Primary completion1 Feb 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Critically-ill children who are medically stable and ready for enteral tube feeds will be randomized to receive either Pediasure or Nourish. Nutritional needs will be calculated per previously established standards at our institution and performed in conjunction with trained dieticians and nutritionists.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajesh Aneja, University of Pittsburgh
- Investigators
- Raj Aneja, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414775
- Sponsor's protocol ID
- STUDY19080289
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2018
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influences of High-fiber, Organic Whole-food Formula on the Gut Microbiome in Critically Ill Children
- ClinicalTrials.gov ID
- NCT03414775
- Acronym / sponsor ID
- STUDY19080289
- Conditions
- Critical Illness, Dysbiosis, Pediatric ALL
- Keywords
- microbiome, gastrointestinal microbiome, pediatrics, critical illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Critically-ill children who are medically stable and ready for enteral tube feeds will be randomized to receive either Pediasure or Nourish. Nutritional needs will be calculated per previously established standards at our institution and performed in conjunction with trained dieticians and nutritionists.
| Arm | Type | Receives |
|---|---|---|
| Pediasure | Active comparator | Other: PediasurePatients assigned to this arm will receive Pediasure |
| Nourish | Active comparator | Other: NourishPatients assigned to this arm will receive Nourish |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Admitted to the pediatric intensive care unit
- Age 1-17 years old
- Previously placed enteric tube designed for enteric feeding
Key exclusion criteria (5 listed)
- Vasoactive medication use
- History of allergies or intolerances to either Pediasure or Nourish
- Whey allergy or intolerance
- Gluten sensitivity or intolerance
- Medical condition that necessitate the use of specific formulas and/or nutritional needs (e.g. epilepsy requiring ketogenic diet, genetic metabolic dysfunction with specific formula requirements)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NourishThe effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome | Other | Nourish |
| PediasureThe effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome | Other | Pediasure |
Primary outcome
Changes to 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
Changes to the gastrointestinal microbiome
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
1 secondary outcome
Concentration of short-chain fatty acids
Time frame: Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raj Aneja, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nourish and Pediasure in people with Critical Illness and Dysbiosis, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes to the gastrointestinal microbiome (time frame: Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.