Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06349590 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery

Study acronym: DIET
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date changed from estimate of Oct 2029 to Apr 6, 2026
    • Interventions: High-fiber/low-fat meals (Dietary Supplement) to High-fiber/low-fat meals (Dietary Supplement)
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 3 entries
  2. Re-verified, no change to tracked fieldsv6
  3. Primary and study completion dates: Sep 2029 to Oct 2029
    • Start date changed from estimate of Sep 2024 to Jun 27, 2024
    v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Interventions: Plant-Based Meals (Dietary Supplement) to High-fiber/low-fat meals (Dietary Supplement)
    • Eligibility criteria expanded, about 32 words
    • Site details revised
    v4
  5. Enrollment target: 20 to 80v3 Show 5 more changesShow less
    • Start date: Jul 2024 to Sep 2024
    • Primary endpoint revised
    • Primary and study completion dates: Jul 2029 to Sep 2029
    • Eligibility criteria shortened, about 25 words
    • Secondary endpoints: 4 to 3
  6. Start date: Apr 2024 to Jul 2024
    • Primary and study completion dates: Apr 2029 to Jul 2029
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
A single arm, prospective, single center Phase1/2 Dietary intervention trial for subjects diagnosed with colorectal cancer and scheduled for tumor resection more than 21 days from informed consent. Subjects will be provided 21 days of standardized High-fiber/low-fat meals and complete a food diary up until lunch on the day prior to surgery. Blood samples will be collected at baseline and on the day of surgery. Stool samples will be collected throughout the dietary intervention period at specific timepoints, on the day of surgery, and 30 days post-surgery. Tissue from the tumor resection will be isolated for organoid cultures. Subjects will be followed per standard of care for up to 5 years or disease recurrence, whichever comes first. Subject may be treated for their cancer prior to surgery and/or during the follow-up period.
Trial Details
NCT Number NCT06349590
Lead Sponsor University of Chicago
Conditions
(from sponsor)		 Colorectal Cancer
Related terms Colorectal Neoplasms
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov