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Search / Trial NCT06560879

Effectiveness of Probiotics for the Prevention of Gastrointestinal Toxicity in Children with Leukemia

Launched by NATIONAL INSTITUTE OF PEDIATRICS, MEXICO · Aug 14, 2024

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

Background Acute lymphoblastic leukemia (ALL) is a malignant disease characterized by the uncontrolled proliferation of immature lymphoid cells. It is the most common neoplasm in children, representing up to 53.1% of all oncologic processes in Mexico \[1-6\]. Fortunately, with the current chemotherapeutic treatments, disease remission is achieved in 98% of cases; however, the chemotherapeutic treatments have side effects that can lead to gastrointestinal toxicity (7.7 to 32.5%), which is associated with up to 50% mortality.

Among the most common gastrointestinal manifestations resulting fr...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients older than 6 years and younger than 17 years with a recent diagnosis of acute lymphoblastic leukemia, confirmed by bone marrow aspirate and interpreted by a pediatric oncologist.
  • Participants of both sexes
  • Participants receiving treatment at the Oncology Service of the Instituto Nacional de Pediatría.
  • Receiving chemotherapy according to national health protocols in the consolidation phase.
  • Informed consent
  • Informed assent for those older than 8 years.
  • Exclusion Criteria:
  • Allergy to probiotics.
  • Consumption of another probiotic
  • Enteropathies affecting intestinal absorption (e.g., malabsorption syndrome, short bowel syndrome, intestinal malrotation, chronic nonspecific ulcerative colitis, Crohn's disease).
  • Chronic diarrhea (\>15 days of duration)
  • Presence of mucosal lesions
  • Impossibility of enteral feeding
  • Renal insufficiency
  • Peritoneal dialysis
  • Water and electrolyte disorders
  • Surgical intestinal bypass (e.g., colostomy, ileostomy)
  • Congenital metabolic disorders
  • Septicemia
  • Body temperature \> 38° C
  • Received broad-spectrum antibiotics (piperacillin/tazobactam, fourth generation cephalosporins, aminoglycosides, carbapenem and/or metronidazole) within the past 30 days.

About National Institute Of Pediatrics, Mexico

The National Institute of Pediatrics (Instituto Nacional de Pediatría) in Mexico is a leading research and clinical institution dedicated to advancing pediatric healthcare through innovative clinical trials and studies. Renowned for its commitment to improving child health outcomes, the Institute focuses on a wide range of pediatric conditions, leveraging its expertise in child development, nutrition, and chronic diseases. By fostering collaboration among healthcare professionals, researchers, and academic institutions, the National Institute of Pediatrics aims to enhance evidence-based practices and contribute to the global body of pediatric knowledge, ultimately striving to provide better healthcare solutions for children in Mexico and beyond.

Locations

Mexico City, Coyoacan, Mexico

Patients applied

0 patients applied

Trial Officials

Sara Espinosa-Padilla, Ph.D.

Study Director

National Institute of Pediatrics

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported