NCT05852990RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 24 Feb 2023
- Start date
- 1 Mar 2022
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Instituto Nacional de Cancerologia de Mexico
- Diseases
- Lung cancer
- NCT number
- NCT05852990
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 28
- From 1 Mar 2022 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with other anti-cancer therapy
Other illness
- Any other serious condition or uncontrolled active infection, altered mental status or psychiatric disorder that, in the investigator´s opinion, would limit the ability of an individual to meet the requirements of the study or which affects the interpretability of the results.
- Active hepatitis virus infection (any serotype) or chronic infection with a potential risk of reactivation evaluated through a serological panel.
- Active HIV infection.
Other
- Patients who cannot attend the first protocol appointment.
- Participating in other clinical trials in the former four weeks
- Breastfeeding.
Who the study is looking for
- Both sexes
- ≥ 18 years old
- Pathologically confirmed diagnosis of NSCLC
- Stage IIIB - IV by the American Joint Committee of Cancer Version 8.
- Candidates to receive EGFR-TKI treatment (1st \& 2nd generation TKI)
- ECOG score ≤ 2
- Life expectancy \> eight weeks
- Signed written informed consent
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Nacional De Cancerologia de Mexico Coordinator of this site? Confirm its status | Mexico City | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.