Physical Exercise and Dairy Probiotics in Childhood Cancer Survivors

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia, Pediatric Behavior Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Motor Activity Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatric Hematology National Institute of Children's Diseases Bratislava

Bratislava, Slovakia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518

Other

The commercial probiotic dairy product has been provided to PALL along with physical training once a day for 8 weeks. Each serving contained 20 billion CFUs of Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518 (Lactobacillus casei CNCMI-1518). Each patient's legal representative was advised to follow a normal diet when preparing and providing food for children.

Physical exercise

Other

The individual online (MS Teams) training program for PALL in the length of 8 weeks included 25-45 minutes of moderate-to-vigorous physical exercise, twice a week, under the supervision. The structure of the exercise program was developed to improve endurance and gradually rebuild muscular strength. The exercise program's structure was created to increase endurance and gradually rebuild muscular strength. Large muscle groups were the focus of training sessions, which also placed a strong emphasis on proper technique. A strength exercise squat was given consideration as a movement required to meet necessities. (e.g., sitting or standing). Each exercise consisted of between 10 and 15 repetitions in each series and 2 to 3 series overall.

Primary outcomes

The shift of gut microbiome by physical exercise and consumption of dairy probiotics.

Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Comenius University

Other

Registry information

Official study title

The Effect of Physical Exercise and Dairy Probiotics (Lactobacillus Casei) on Gut Microbiome in Childhood Cancer Survivors

Acronym: Exerbioall

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jul 11, 2023
Registry last updated: Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed