Lactobacillus Plantarum in Preventing Acute Graft Versus Host Disease in Children Undergoing Donor Stem Cell Transplant
Doctors are studying a type of good bacteria, called Lactobacillus plantarum, to see if it can help prevent a serious condition called acute graft versus host disease (aGvHD) in children and young adults. aGvHD can happen after a stem cell transplant, especially if the new cells see the patient's body as 'foreign' and attack it. This study will involve children and young adults with blood cancers like leukaemia or lymphoma who are having a stem cell transplant from a donor. Some will receive the good bacteria, and others a placebo (a dummy treatment), to see if the good bacteria can reduce the chances of developing aGvHD, particularly in the gut.
At a glance
Results
Results from this study
Posted July 2023Results have been published for this study.
What is this study about?
When children and young adults with serious conditions like leukaemia or lymphoma need a new set of healthy blood cells, they might have a 'donor stem cell transplant'. This is a big treatment where they receive cells from another person. Sometimes, these new donor cells can see the patient's body as different and start to attack it. This is called 'graft versus host disease' (GvHD), and it can be a very serious problem, especially when it affects the gut.
This study is trying to find a way to prevent this serious gut problem. Researchers are looking at a type of 'good bacteria' called Lactobacillus plantarum. You might have heard of similar good bacteria in yogurts or other food supplements. The idea is that giving these good bacteria might help the gut stay healthy and prevent the new donor cells from causing damage.
The study wants to see if giving this special good bacteria (Lactobacillus plantarum) can reduce the number of children and young adults who get gut-related GvHD after their transplant. They will also look at whether it helps keep the gut lining strong, affects other 'bad' bacteria like C. difficile, and could even shorten hospital stays. Ultimately, they hope to find a safe and helpful way to make stem cell transplants safer for young patients.
Key takeaways
- Looks at preventing serious gut problems after stem cell transplants.
- Uses a 'good bacteria' called Lactobacillus plantarum.
- For children and young adults (age 2-25) with blood cancers.
- Participants will get either the active bacteria or a dummy treatment.
- Aims to make stem cell transplants safer and improve recovery.
- Participation involves daily treatment and close monitoring.
Who may be eligible?
This study is looking for children and young adults between the ages of 2 and 25. You would be considered if you have a blood cancer like leukaemia or lymphoma and are planning to have a stem cell transplant from a particular type of donor. This usually means a donor who isn't a perfect match from your immediate family, or an unrelated donor who isn't a perfect match.
There are a few health checks to make sure you're well enough for the study. For example, your doctor will check your general health and how active you are. It's also important that you haven't taken any other special 'good bacteria' (probiotic) supplements in the last month, although eating yoghurt is fine.
You wouldn't be able to join if you're getting stem cells from a perfectly matched family donor, or if you have certain serious gut problems, like a history of severe bowel inflammation or surgery. Pregnant girls also can't take part. The medical team will check all these things carefully to make sure the study is right and safe for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 2 and 25 years old?
- Are you having a stem cell transplant from an 'alternative' donor (not a perfectly matched family donor)?
- Have you avoided taking other 'good bacteria' supplements recently (yogurt is okay)?
- Do you have good general health and activity levels for your condition?
- Do you not have a history of severe gut problems or bowel surgery?
What does participation involve?
If you decide to join this study, you'll be put into one of two groups by chance, like flipping a coin. One group will receive the Lactobacillus plantarum bacteria, and the other group will get a 'placebo' – this looks exactly the same but contains no active ingredients. This is a common way to test if a new treatment works.
Both groups will take their assigned treatment every day. This will start around the time you begin your transplant preparation (chemotherapy or radiotherapy) and continue for about 56 days after your stem cell transplant. You'll take it by mouth, or if you have a feeding tube, it can be given through that. Throughout this time, and at regular check-ups after your transplant, the doctors and nurses will monitor your health very closely. They'll check for any signs of gut problems, take samples (like blood or stool) to see how your body is responding, and track your overall recovery. The full duration of your participation in the study, including follow-up, will be decided by the medical team.
Potential risks and benefits
Locations (43)
- Children's Hospital of AlabamaVerified postcodeBirmingham, United States
- City of Hope Comprehensive Cancer CenterVerified postcodeDuarte, United States
- Children's Hospital Los AngelesVerified postcodeLos Angeles, United States
- UCSF Benioff Children's Hospital OaklandVerified postcodeOakland, United States
- Rady Children's Hospital - San DiegoVerified postcodeSan Diego, United States
- UCSF Medical Center-Mission BayVerified postcodeSan Francisco, United States
- Children's Hospital ColoradoVerified postcodeAurora, United States
- Yale UniversityVerified postcodeNew Haven, United States
- Alfred I duPont Hospital for ChildrenVerified postcodeWilmington, United States
- Children's National Medical CenterVerified postcodeWashington D.C., United States
- University of Florida Health Science Center - GainesvilleVerified postcodeGainesville, United States
- Nemours Children's Clinic-JacksonvilleVerified postcodeJacksonville, United States
Common questions
What is 'acute graft versus host disease'?
It's a serious problem after a stem cell transplant where the new cells from the donor attack the patient's body, often causing problems in the gut, skin, or liver.
What is Lactobacillus plantarum?
It's a type of 'good bacteria' that naturally lives in the human gut. We're testing if it can help prevent gut problems after a transplant.
Will I know if I'm getting the active treatment or the placebo?
No, neither you nor your doctors will know which treatment you are receiving until the study is over. This helps ensure fair and accurate results.
How will the treatment be given?
You will take it by mouth every day, or if you have a feeding tube, it can be given through that.
Can I eat yogurt or other foods with good bacteria?
Yes, eating yogurt is allowed, but you shouldn't take any other concentrated 'good bacteria' (probiotic) supplements before or during the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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