Exerbioall: Physical Exercise and Dairy Probiotics in Childhood Cancer Survivors

Sponsor

Comenius University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05939791

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia, Pediatric	Other: Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518 Other: Physical exercise	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 1, 2022

Actual Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pediatric oncology patients Children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years	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. Other: 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.

Arm

Intervention/Treatment

Experimental: Pediatric oncology patients

Children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years

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.

Other: 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pediatric Hematology National Institute of Children's Diseases Bratislava	Bratislava		Slovakia

Sponsors and Collaborators

Comenius University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Comenius University

ClinicalTrials.gov Identifier:

NCT05939791

Other Study ID Numbers:

ComeniusU

First Posted:

Jul 11, 2023

Last Update Posted:

Jul 13, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Comenius University

Physical Exercise, Gut Microbiome, Exercise Training, Veillonella

Additional relevant MeSH terms:

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Study Results

No Results Posted as of Jul 13, 2023