Physical Exercise and Dairy Probiotics in Childhood Cancer Survivors

Not Applicable

Completed

• Conditions: Acute Lymphoblastic Leukemia, Pediatric
• Interventions: Other: Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518; Other: Physical exercise

• Registration Number: NCT05939791
• Lead Sponsor: Comenius University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-11
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise training	Physical exercise	Children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years with physical exercise intervention
Exercise training	Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518	Children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years with physical exercise intervention

Primary Outcome Measures

Name	Time	Method
The shift of gut microbiome by physical exercise and consumption of dairy probiotics.	8 weeks

Trial Locations

Locations (1)

Department of Pediatric Hematology National Institute of Children's Diseases Bratislava; 🇸🇰 Bratislava, Slovakia