Physical Exercise and Dairy Probiotics in Childhood Cancer Survivors

Acute Lymphoblastic Leukemia, Pediatric Clinical Trial

— Exerbioall  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05939791
• Other study ID #: 22-0047
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Comenius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia, Pediatric
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518
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
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.

Locations

Country	Name	City	State
Slovakia	Department of Pediatric Hematology National Institute of Children's Diseases Bratislava	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Comenius University

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The shift of gut microbiome by physical exercise and consumption of dairy probiotics.		8 weeks