Status:
ENROLLING_BY_INVITATION
Effectiveness of Probiotics for the Prevention of Gastrointestinal Toxicity in Children with Leukemia
Lead Sponsor:
National Institute of Pediatrics, Mexico
Conditions:
Probiotics
Gastrointestinal Diseases
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief Summary
Background: Acute lymphoblastic leukemia (ALL) is a common malignant neoplasm in children. Although chemotherapy achieves remission in over 70% of cases, it can cause gastrointestinal toxicity in up t...
Detailed Description
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, representin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06560879
Start Date
February 1 2025
End Date
August 31 2026
Last Update
March 14 2025
Active Locations (1)
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1
National Institute of Pediatrics
Mexico City, Coyoacan, Mexico, 04530