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RECRUITING NA

Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial

NCT06216899 · View on ClinicalTrials.gov ↗

Study Summary

This study will compare the tolerability and efficacy of conventional formula Exclusive Enteral Nutrition (EEN) and whole-food blended smoothie EEN by enrolling a total of 60 participants with newly diagnosed pediatric Crohn's disease (CD). Participants will be provided either commercial formula or guided on the preparation of the home-blended smoothie. These participants will be given a specific recipe, blender, and be provided the food components to the smoothie. The study will total 8 weeks and will assess tolerance, clinical outcomes, stool microbiome, and quality of life.

Conditions Studied

Interventions

  • OTHER Whole-food based smoothie
  • OTHER Formula

Study Locations (3)

Pennsylvania

  • Children's Hospital of Philadelphia — Philadelphia

Washington

  • Seattle Children's Hospital — Seattle

Nova Scotia

  • Izaak Walton Killam Health Centre — Halifax

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2024-03-11
Est. Completion 2030-01-10
Phase NA

Sponsor

Seattle Children's Hospital

127 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06216899

The ClinicalTrials.gov registry entry for NCT06216899 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Children's Hospital, which has 127 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 2 interventions — of which Whole-food based smoothie is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06216899 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Pennsylvania, Washington, Nova Scotia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06216899 about?

NCT06216899 is a clinical study titled "Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial". This study will compare the tolerability and efficacy of conventional formula Exclusive Enteral Nutrition (EEN) and whole-food blended smoothie EEN by enrolling a total of 60 participants with newly diagnosed pediatric Crohn's disease (CD). Participants will be provided either commercial formula or...

What is the current status of trial NCT06216899?

This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2024-03-11. Estimated completion is 2030-01-10.

What conditions does trial NCT06216899 study?

This clinical trial studies the following conditions: Crohn Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06216899?

The interventions under investigation include: Whole-food based smoothie (OTHER), Formula (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06216899?

This trial is sponsored by Seattle Children's Hospital, which has 127 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06216899 being conducted?

This trial has 3 study locations across Pennsylvania, Washington, Nova Scotia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial