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Search / Trial NCT06431048

No DIET Trial: Dogmatic Interruption of Enteral nuTrition

Launched by JEFFREY COUGHENOUR · May 24, 2024

Trial Information

Current as of November 12, 2025

Enrolling by invitation

Keywords

Percutaneous Endoscopic Gastrostomy Tracheostomy Enteral Feeding

ClinConnect Summary

The No DIET Trial is studying the best time to stop tube feeding before planned airway procedures (tracheostomy or PEG tube placement). In a randomized setup, participants are assigned to one of two timing strategies: stop nutrition when they’re called to the operating room, or stop nutrition 2 hours before the scheduled procedure. The main goal is to see how much stomach content is present in the first 0–8 hours after stopping feeding, to understand the risk of aspiration during the procedure. There are two patient groups in the study: those with a PEG tube who are having a tracheostomy, and those with naso-enteral feeding who are having a PEG placed.

Who can participate and what to expect: Adults 18 and older who require a tracheostomy or PEG placement can be eligible. Key exclusions include having a gastric or bowel obstruction, inability to receive enteral nutrition, or pregnancy/breastfeeding. The trial will be conducted at the University of Missouri Hospital in Columba, Missouri, and is currently enrolling by invitation with an estimated 120 participants. Participation involves random assignment to one of the two feeding-stop timing strategies, with researchers measuring stomach contents around the time of surgery. Results are not yet available, and the study is not FDA-regulated. Primary completion is expected in 2026.

Gender

ALL

Eligibility criteria

  • Inclusion criteria:
  • Patients aged \>18 years.
  • Patients who require a tracheostomy or PEG placement.
  • Exclusion criteria:
  • Patients with gastric and/or bowel obstruction.
  • Patients unable to receive enteral nutrition.
  • Patients who are pregnant and/or breastfeeding.

About Jeffrey Coughenour

Jeffrey Coughenour is a dedicated clinical trial sponsor known for his commitment to advancing medical research and improving patient outcomes. With a strong background in clinical operations and trial management, he specializes in overseeing the development and execution of innovative clinical studies across various therapeutic areas. His leadership is characterized by a strategic approach to trial design, regulatory compliance, and stakeholder engagement, ensuring that projects are conducted efficiently and ethically. Jeffrey's passion for enhancing healthcare solutions is reflected in his collaborative efforts with research institutions and healthcare professionals, driving progress in the clinical research landscape.

Locations

Columbia, Missouri, United States

Patients applied

0 patients applied

Trial Officials

Jeffrey Coughenour, MD

Principal Investigator

University of Missouri-Columbia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported