NCT05852990

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

Effect of Glutamine Plus Lactobacillus Reuteri Added to an Astringent Diet in Preventing Diarrhea Caused by Tyrosine Kinase Inhibitors (TKIs) in Patients With Advanced Non-small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Instituto Nacional de Cancerologia de Mexico · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients in the experimental group will receive two sachets of Glutapak-R every twelve hours for up to six weeks alongside treating physician-chosen EGFR therapy. Patients in the control group will receive a standard-of-care diet. All patients will receive nutritional counseling every two weeks.

Conditions

• Non-Small Cell Lung Cancer With EGFR Mutation

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Glutamine plus L. reuteri	Glutamine plus Lactobacillus reueri twice daily for up to 6 weeks or death

Timeline

• Start date: 2022-03-01
• Primary completion: 2026-12-01
• Completion: 2027-12-12
• First posted: 2023-05-10
• Last updated: 2026-04-09

Locations

1 site across 1 country: Mexico

Regulatory

• FDA-regulated drug study