Acute Lymphoblastic Leukemia, PediatricExerbioallNCT05939791
Physical Exercise and Dairy Probiotics in Childhood Cancer Survivors
A study testing Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518 and Physical exercise in people with Acute Lymphoblastic Leukemia, Pediatric, run by Comenius University at 1 site in Slovakia.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Pediatric
- What is being tested?
- Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518 and Physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Apr 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years
Who cannot join
- acute respiratory infection during intervention
- more than 20% skipped exercise training sessions
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
Department of Pediatric Hematology National Institute of Children's Diseases Bratislava
Bratislava
About this study
Official title: The Effect of Physical Exercise and Dairy Probiotics (Lactobacillus Casei) on Gut Microbiome in Childhood Cancer Survivors
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.
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Being tested
- Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518, Physical exercise
- Keywords
- Physical Exercise, Gut Microbiome, Exercise Training, Veillonella
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518Other
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 exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | Children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years with physical exercise intervention Receives: Other: Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518; Other: Physical exercise |
| Passive | No intervention | Children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years without physical exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The shift of gut microbiome by physical exercise and consumption of dairy probiotics.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Apr 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia, PediatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939791
- Sponsor's protocol ID
- 22-0047
- Acronym
- Exerbioall
- Status last verified
- Jan 2024
- First submitted
- 3 Jul 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Exercise and Dairy Probiotics (Lactobacillus Casei) on Gut Microbiome in Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT05939791
- Acronym / sponsor ID
- Exerbioall / 22-0047
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Keywords
- Physical Exercise, Gut Microbiome, Exercise Training, Veillonella
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Other: Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518, Other: Physical exerciseChildren 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 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years
Key exclusion criteria (2 listed)
- acute respiratory infection during intervention
- more than 20% skipped exercise training sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518The 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 | Exercise training |
| Physical exerciseThe 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. | Other | Exercise training |
Primary outcome
The shift of gut microbiome by physical exercise and consumption of dairy probiotics.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518 and Physical exercise in people with Acute Lymphoblastic Leukemia, Pediatric, run by Comenius University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The shift of gut microbiome by physical exercise and consumption of dairy probiotics. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.