Physical Exercise and Dairy Probiotics in Childhood Cancer Survivors (Exerbioall)

Comenius University

Status: Completed

Conditions: Acute Lymphoblastic Leukemia, Pediatric

Treatments: Other: Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518; Other: Physical exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05939791

22-0047

Details and patient eligibility

About

The goal of this clinical trial is to to compare the structure of the intestinal microbiome between children shortly after treatment for acute lymphoblastic leukemia (1-3 years after cancer treatment) and healthy controls. And then to provoke a positive shift of bacterial diversity by physical activity and probiotics in cured pediatric oncology patients with persistent gut microbiome disruptions.

The main question[s] it aims to answer are:

• Are differences in bacterial richness between healthy controls and pediatric oncology patients ≥12 months after cancer treatment apparent?
• Has the combination of physical exercise and probiotics had a positive influence on the structure of the gut microbiome in childhood cancer survivors in remission? Two times per week of physical activity and daily dairy consumption with probiotics will be required of participants for eight weeks.

Enrollment: 29 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years

Exclusion criteria

• acute respiratory infection during intervention
• more than 20% skipped exercise training sessions

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Exercise training

Experimental group

Description:

Children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years with physical exercise intervention

Treatment:

Other: Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518

Other: Physical exercise

Passive

No Intervention group

Description:

Children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years without physical exercise intervention