Physical Exercise and Dairy Probiotics in Childhood Cancer Survivors

Study Overview
=================
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.

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

Conditions
-----------------
Acute Lymphoblastic Leukemia, Pediatric

Intervention / Treatment
-----------------
* Other: Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518
* Other: Physical exercise


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pediatric oncology patients<br>Children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years | Other: Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518<br>* 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.<br>Other: Physical exercise<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The shift of gut microbiome by physical exercise and consumption of dairy probiotics. |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical Exercise, Gut Microbiome, Exercise Training, Veillonella