Tests probiotics to prevent gut side effects in children with leukemia
Tests probiotic capsules against placebo in children with acute lymphoblastic leukemia.
Plain-language title generated from the registry record
Registry title: Effectiveness of Probiotics for the Prevention of Gastrointestinal Toxicity in Children With Leukemia
Key facts
- Where
- Mexico City, MexicoSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 17 years old?
Source: NCT06560879, who can take part
Where in Mexico
- National Institute of PediatricsMexico City, MexicoNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Institute of Pediatrics, Mexico
- Trial code
- NCT06560879
- Record updated
- 14 March 2025
- Original description
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 to 32.5%. Some studies suggest that administering probiotics reduces this risk, but the evidence remains inconsistent.Read full original descriptionShow less
Effectiveness of Probiotics for the Prevention of Gastrointestinal Toxicity and Changes in Gut Microbiota in Children With Acute Lymphoblastic Leukemia
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 to 32.5%. Some studies suggest that administering probiotics reduces this risk, but the evidence remains inconsistent.
Objective: To evaluate the effectiveness and safety of administering L. casei, L. rhamnosus or B. bifidum compared to a placebo for the prevention of gastrointestinal toxicity, decreased intestinal permeability, and changes in intestinal microbiota in pediatric patients diagnosed with acute lymphoblastic leukemia receiving chemotherapy.
Methods: A total of 120 participants aged 6 to 17 years, diagnosed with ALL and receiving consolidation phase chemotherapy without gastrointestinal comorbidities, will be included. Participants will be administered daily 2 capsules containing either 1) L. casei, 2) L. rhamnosus, 3) B. bifidum or 4) placebo daily for 8 weeks. The clinical status of the participants will be evaluated weekly by the oncology service to determine the presence of gastrointestinal toxicity and adverse events. Changes in intestinal permeability will be assessed by measuring beta-lactoglobulin in a blood sample using the ELISA technique, while changes in the intestinal microbiota will be analyzed by genomic sequencing at baseline and at the end of follow-up.
Statistical analysis: Descriptive analysis will use measures of central tendency and dispersion. For quantitative variables, the mean and standard deviation or median with minimum and maximum values will be calculated depending on the distribution type. Frequencies and proportions will be calculated for qualitative variables, presented in tabular and graphical form. To compare the quantitative variables between the four interventions, a multi-way ANOVA test will be used.
The risk of gastrointestinal toxicity and adverse events will be analyzed by calculating the relative risk and 95% confidence interval. Differences between the interventions will be analyzed using survival analysis with the Kaplan-Meier and Log-Rank tests. Sequencing data will be analyzed using the Qiime2 program, filtered to generate a phylogenetic tree using the Silva database. Corresponding plots will be generated for each taxonomic level. Alpha (intra-group) and Beta (inter-group) diversity will be presented by ordination plots using principal component analysis with the ANCOM program
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: Surgical intestinal bypass (e.g., colostomy, ileostomy); Received broad-spectrum antibiotics (piperacillin/tazobactam, fourth generation cephalosporins, aminoglycosides, carbapenem and/or metronidazole) within the past 30 days; Allergy to probiotics; Enteropathies affecting intestinal absorption (e.g., malabsorption syndrome, short bowel syndrome, intestinal malrotation, chronic nonspecific ulcerative colitis, Crohn's disease); Renal insufficiency; Water and electrolyte disorders; Congenital metabolic disorders; Consumption of another probiotic; Chronic diarrhea (>15 days of duration); Presence of mucosal lesions; Impossibility of enteral feeding; Peritoneal dialysis; Septicemia; Body temperature > 38° C.