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Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 1, 2025 to Dec 1, 2026
    • Study completion date: Dec 12, 2025 to Dec 12, 2027
    • Site details revised
    v3
  2. Primary completion date: Dec 1, 2023 to Dec 1, 2025
    • Study completion date: Dec 12, 2023 to Dec 12, 2025
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This open-label randomized clinical trial aims to evaluate the glutamine plus Lactobacillus reuteri supplementation effect in a standard-of-care diet in EGFR mutant patients with advanced non-small cell lung cancer (NSCLC) under tyrosine kinase inhibitors (TKIs) therapy. The main question it aims to answer is ¿What is the effect of glutamine plus L. reuteri added to an astringent diet in preventing diarrhea generated by TKI therapy? Patients will receive an astringent diet supplemented with 10 grams of glutamine and L. reuteri (100 million CFU). Researchers will compare the Glutamine plus L. reuteri diet with a standard astringent diet to see if TKI therapy diarrhea is prevented.
Trial Details
NCT Number NCT05852990
Lead Sponsor Instituto Nacional de Cancerologia de Mexico
Conditions
(from sponsor)		 Non-Small Cell Lung Cancer With EGFR Mutation
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov