An interventional study of Nourish and Pediasure in Critical Illness, Dysbiosis and Pediatric ALL, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Other
Among 44 studies in Dysbiosis with a site in United States — 14 open to participants now, 20 under way, none of them phase 3. Dysbiosis · United States.
Among the 44 studies in Dysbiosis with a site in United States, this one is the 25th largest by enrollment of the 35 interventional ones that give a count, is one of 5 that started in 2018, is one of 20 with no phase, and was the 7th registered.
187 studies on the registry are indexed under Dysbiosis; 64 are open to participants now.
Browse Dysbiosis studies →14 of the 44 studies in Dysbiosis with a site in United States are open now. Recruiting first, the newest first:
Florida State University · Sites in United States
Ages 6–13 · Healthy volunteers
Florida State University · Sites in United States
Ages 6–13 · Healthy volunteers
Freya Biosciences ApS · Sites in United States
Ages 18–45 · Women only
University of California, Davis · Sites in United States
Ages 45–70 · Healthy volunteers
Florida State University · Sites in United States
Ages 6–13 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 41 Dysbiosis studies recruiting now, 14 (34%) set no upper age limit and 24 (59%) stop at 75 or younger; 10 take children under 18; 18 take healthy volunteers.
This study: 1 Year to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
44 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 5 · Phase 4 5
First in 2009; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 32 is below the median of 60 across 132 interventional studies indexed under Dysbiosis.
Median enrollment 48 across the 35 interventional studies, 58 across the 8 observational. Of the 21 that completed or were terminated, 6 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 44 have an industry lead sponsor. The 10 most frequent:
University of Pittsburgh is the lead sponsor of 1,420 studies on the registry; 169 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
University of Pittsburgh has 1 study filed under Dysbiosis — fewer than ten, so there is no comparison to draw.
8 of the studies in Dysbiosis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06544954University of California, DavisPrebiotic Effects of California Grapes on Gut Health and Cardiometabolic Health in Overweight Men and Women | 2026-11 |
| NCT06588218Florida State UniversityEffect of Watermelon on Gut and Cardiometabolic Health | 2026-12 |
| NCT05288790Vanderbilt University Medical CenterMicrobiome Metabolites and Alcohol in HIV to Reduce CVD RCT | 2027-03-31 |
| NCT06916936Florida State UniversityEffect of Peanut Butter on Gut and Metabolic Health | 2027-05 |
| NCT06636669Boston Medical CenterProbiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee | 2027-06 |
Add all 8 to your calendar (.ics) → With an account.
Among the 44 studies in Dysbiosis with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
187 studies on the registry are indexed under Dysbiosis; 64 are open to participants now.
This study's enrollment of 32 is below the median of 60 across 132 interventional studies indexed under Dysbiosis.
Browse Dysbiosis studies →University of Pittsburgh is the lead sponsor of 1,420 studies on the registry; 169 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Compared within Dysbiosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients assigned to this arm will receive Pediasure
Other: Pediasure
Patients assigned to this arm will receive Nourish
Other: Nourish
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
Changes to the gastrointestinal microbiome
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
Changes to the gastrointestinal microbiome
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
Concentration of short-chain fatty acids
Fecal samples will be analyzed by gas chromatography
Time frame: Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Feb 2025, 83 months.
Of 71 non-industry interventional studies with no phase under Dysbiosis, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 28. This study's 83 months is above that.
Counting every sponsor, half of 83 studies reached it within 19 months; a quarter within 10 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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