Physical Exercise and Dairy Probiotics in Childhood Cancer Survivors (Exerbioall)
Primary Purpose
Acute Lymphoblastic Leukemia, Pediatric
Status
Recruiting
Phase
Not Applicable
Locations
Slovakia
Study Type
Interventional
Intervention
Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518
Physical exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Lymphoblastic Leukemia, Pediatric focused on measuring Physical Exercise, Gut Microbiome, Exercise Training, Veillonella
Eligibility Criteria
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
Sites / Locations
- Department of Pediatric Hematology National Institute of Children's Diseases BratislavaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pediatric oncology patients
Arm Description
Children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years
Outcomes
Primary Outcome Measures
The shift of gut microbiome by physical exercise and consumption of dairy probiotics.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05939791
Brief Title
Physical Exercise and Dairy Probiotics in Childhood Cancer Survivors
Acronym
Exerbioall
Official Title
The Effect of Physical Exercise and Dairy Probiotics (Lactobacillus Casei) on Gut Microbiome in Childhood Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Comenius University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, Pediatric
Keywords
Physical Exercise, Gut Microbiome, Exercise Training, Veillonella
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pediatric oncology patients
Arm Type
Experimental
Arm Description
Children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years
Intervention Type
Other
Intervention Name(s)
Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physical exercise
Intervention Description
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 Outcome Measure Information:
Title
The shift of gut microbiome by physical exercise and consumption of dairy probiotics.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabina Šmahová, MD
Phone
+421 0910 261 810
Email
sabina.smahova@fmed.uniba.sk
Facility Information:
Facility Name
Department of Pediatric Hematology National Institute of Children's Diseases Bratislava
City
Bratislava
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabina Šmahová, MD
First Name & Middle Initial & Last Name & Degree
Viktor Bielik, prof.
First Name & Middle Initial & Last Name & Degree
Alexandra Kolenová, prof.
First Name & Middle Initial & Last Name & Degree
Ivan Hric, PhD.
First Name & Middle Initial & Last Name & Degree
Miriam Tkáčiková, Ms
First Name & Middle Initial & Last Name & Degree
Libuša Kubáňová, PhD.
First Name & Middle Initial & Last Name & Degree
Veronika Hlaváčová, Ms
12. IPD Sharing Statement
Plan to Share IPD
No
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Physical Exercise and Dairy Probiotics in Childhood Cancer Survivors
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