Physical Exercise and Dairy Probiotics in Childhood Cancer Survivors

NCT05939791 — Not applicable, Completed, 29 participants, Comenius University

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

Registry	NCT05939791, acronym Exerbioall
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	29 (Actual)
Sponsor	Comenius University (Other)
Conditions	Acute Lymphoblastic Leukemia, Pediatric
Interventions	Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518, Physical exercise (Other)
Dates	start 2022-04-01, primary completion 2023-12-31, completion 2023-12-31, first posted 2023-07-11, last updated 2024-01-16
Locations	1 site in Slovakia

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Exercise training	Experimental	Other: Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518; Other: Physical exercise	Children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years with physical exercise intervention
Passive	No intervention		Children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years without physical exercise intervention

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.

+Outcome measures

Primary outcomes

The shift of gut microbiome by physical exercise and consumption of dairy probiotics. [8 weeks]

+Eligibility

Sex: All, ages: 6 Years to 12 Years, 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

+Locations (1)

Facility	City	Country	Status
Department of Pediatric Hematology National Institute of Children's Diseases Bratislava	Bratislava	Slovakia