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

PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

February 1, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

August 31, 2026

Conditions
ProbioticsGastrointestinal DiseasesPrecursor Cell Lymphoblastic Leukemia-Lymphoma
Interventions
BIOLOGICAL

Lactobacillus casei

Lacticaseibacillus casei is a species of Gram-positive anaerobic bacteria found in the intestine and mouth of humans. This lactic acid-producing bacterium is used in the dairy industry in the production of probiotic foods.

BIOLOGICAL

Lactobacillus rhamnosus

A live form of a bacterium that makes lactic acid (a substance derived from milk sugars and also made by the body). Lactobacillus rhamnosus GG is given to help with digestion and normal bowel function. In addition, it may help maintain a healthy gastrointestinal tract. It is being studied for the prevention of infections in patients who received donor stem cell transplants and for other conditions.

BIOLOGICAL

Bifidobacterium bifidum

B. bifidum is an essential bacteria found in the human intestine. When it is low or absent all together in the human intestine, it is an indication of being in an unhealthy state. Intestinal flora can be improved if someone takes oral B. bifidum. Also, oral B. bifidum is used for other things such as therapy for enteric and hepatic disorders, for activating the immune response, and for preventing some cancers

DIETARY_SUPPLEMENT

Placebo

Microcrystalline cellulose is a term for refined wood pulp and is used as a texturizer, an anti-caking agent, a fat substitute, an emulsifier, an extender, and a bulking agent in food production.The most common form is used in vitamin supplements or tablets

Trial Locations (1)

04530

National Institute of Pediatrics, Mexico City

All Listed Sponsors
lead

National Institute of Pediatrics, Mexico

OTHER_GOV