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

April 6, 2026 updated by: Oscar Gerardo Arrieta Rodríguez, Instituto Nacional de Cancerologia de Mexico

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Oscar G Arrieta Rodriguez, M.D., M.Sc.
  • Phone Number: 711101 556280400
  • Email: ogar@unam.mx

Study Locations

  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 14080
        • Recruiting
        • Instituto Nacional De Cancerologia de Mexico
        • Contact:
          • Oscar G Arrieta Rodriguez, M.D., M.Sc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who cannot attend the first protocol appointment.
  • Treatment with other anti-cancer therapy
  • Participating in other clinical trials in the former four weeks
  • 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.
  • Breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention diet
Astringent diet supplemented with one sachet containing 10 grams of glutamine plus 100 million Colony Forming Units (CFU) of Lactobacillus reueri every 12 hours, from baseline treatment up to 6 weeks or death.
Combination product: Glutamine plus L. reuteri
Glutamine plus Lactobacillus reueri twice daily for up to 6 weeks or death
Other Names:
  • Glutapak-R
No Intervention: Standard diet
Astringent diet from baseline treatment up to 6 weeks or death.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diarrhea toxicity
Time Frame: every two weeks, from first dose of TKI therapy up to six weeks.

The diarrhea grade will be determined from 1 to 5 following the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. As shown below:

grade 1: Increase of < 4 stools per day over baseline; mild increase in ostomy output compared to baseline grade 2: Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline; limiting instrumental ADL.

grade 3: Increase of >= 7 stools per day over baseline; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care ADL.

grade 4: Life-threatening consequences; urgent intervention indicated grade 5: Death
every two weeks, from first dose of TKI therapy up to six weeks.
Functional Assessment of Chronic Illness Therapy
Time Frame: Every two weeks, from first dose of TKI therapy up to six weeks.
This assessment will be evaluated with a specific scale for diarrhea (FACIT instrument), which consists of 11 items that assign a value of 0 to 4 for each one. Higher the score, the better quality of life related to diarrhea.
Every two weeks, from first dose of TKI therapy up to six weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade of gastrointestinal toxicity
Time Frame: Every two weeks, from first dose of TKI therapy up to six weeks.
This outcome will be determined from grades 1 to 5 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for gastrointestinal disorders.
Every two weeks, from first dose of TKI therapy up to six weeks.
Measurement of health related quality of life (QoL)
Time Frame: Every two weeks, from first dose of TKI therapy up to six weeks.
The QoL of patients with cancer will be determined by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 (EORTC QLQ-C30 v3.0) instrument.
Every two weeks, from first dose of TKI therapy up to six weeks.
Measurement of quality of life (QoL) for lung cancer patients
Time Frame: Every two weeks, from first dose of TKI therapy up to six weeks.
The QoL for Lung Cancer patients will be determined by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 (EORTC QLQ-LC13) instrument.
Every two weeks, from first dose of TKI therapy up to six weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancerologia de Mexico

Investigators

  • Principal Investigator: Oscar G Arrieta Rodriguez, M.D., M.Sc., Instituto Nacional De Cancerologia de Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 12, 2027

Study Registration Dates

First Submitted

February 24, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI/1565/21 INCAN/CEI/0074/22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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