Clinical trial · Interventional
Influences of High-fiber, Organic Whole-food Formula on the Gut Microbiome in Critically Ill Children
NCT03414775CI-TRIAL-00100602completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Critical Illness | — | UNRESOLVED | — |
| Dysbiosis | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nourish | Other | — | UNRESOLVED |
| Pediasure | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Pediasure
- description
- Patients assigned to this arm will receive Pediasure
- interventionNames
- Other: Pediasure
- type
- ACTIVE_COMPARATOR
- label
- Nourish
- description
- Patients assigned to this arm will receive Nourish
- interventionNames
- Other: Nourish
Primary outcomes (2)
- measure
- Changes to the gastrointestinal microbiome
- timeFrame
- Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Admitted to the pediatric intensive care unit * Age 1-17 years old * Previously placed enteric tube designed for enteric feeding Exclusion Criteria: * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.