Effect of faecal microbiota transplant on the expression of autism spectrum disorder core symptoms in children – open-label phase II clinical trial (FMT-PAS)
This research is looking at a new way to help children with autism spectrum disorder (ASD). The study is called FMT-PAS and it's investigating a treatment called a faecal microbiota transplant (FMT). This involves giving children healthy gut bacteria from a donor. Doctors want to see if this treatment can lead to an improvement or worsening of the main symptoms of autism. This is a "Phase II" study, which means it's an early step to understand if the treatment is effective and safe before it can be widely used. They will measure changes in symptoms using a special assessment tool. They will also look at any side effects and other changes in health and quality of life.
Auf einen Blick
Worum geht es in dieser Studie?
This study is about understanding if a treatment called a faecal microbiota transplant (FMT) could help children who have autism spectrum disorder (ASD). At Patient.info, we know that many families affected by autism are keen to find new ways to help manage symptoms and improve daily life. This research aims to explore if changing the balance of bacteria in a child's gut might have an impact on some of the core symptoms of autism.
FMT works by taking healthy gut bacteria from a donor and giving it to someone else. The idea is that these new, healthy bacteria might improve the way the gut works, and potentially, how the brain works too – this is sometimes called the 'gut-brain axis'. This particular study is a 'Phase II' trial, which means it’s an important step to see if the treatment has a noticeable effect and if it's safe for children with autism. It's not the final step before a treatment becomes widely available, but it gives researchers crucial information.
To find out if the treatment works, the doctors will carefully measure changes in the children's autism symptoms using a special assessment tool. They'll be looking for changes like an improvement or, in some cases, a worsening of symptoms. Alongside this, they will also keep a close eye on any side effects, how the children's bowel habits change, their overall quality of life, and other health features. This detailed approach helps researchers get a full picture of the treatment's impact.
Wichtige Erkenntnisse
- The study explores if gut bacteria transplants can help children with autism.
- It's a Phase II study, meaning it's an early stage of testing.
- Researchers will track changes in autism symptoms and look for side effects.
- Both boys and girls of any age may be able to join based on full eligibility criteria.
- Participation involves receiving the treatment and attending appointments for assessments.
- Sie können jederzeit von der Studie zurücktreten.
Wer könnte berechtigt sein?
To join this study, children can be of any age. Both boys and girls are welcome to take part. The researchers will have specific reasons why certain children might be a good fit for the study and others might not.
For example, they'll check things like a child's current health, any other medical conditions they might have, and medications they are already taking. They need to make sure that taking part in the study is as safe as possible for every child.
It's very important to talk to your child's doctor or the study team to understand all the exact requirements. They can tell you if your child could be eligible and answer any questions you have.
Könnte diese Studie für Sie geeignet sein?
Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.
- Is my child diagnosed with autism spectrum disorder?
- Is my child a boy or a girl? (Both sexes are welcome)
- Is my child within an age range that the study might consider? (Any age)
- Are there any other medical conditions or medications my child takes that might affect study participation?
Was beinhaltet die Teilnahme?
If your child takes part in this study, they will receive a special liquid medicine called a 'suspension for faecal microbiota transplantation'. This treatment contains healthy gut bacteria. The doctors will monitor your child closely to see how their autism symptoms change. They will use a specific test called ADOS-2, Module 1, which helps measure the intensity of autism symptoms. They will also track any side effects your child might experience, changes in bowel movements using something called the Bristol stool scale, and ask you to fill out several questionnaires about their health, daily life, and behaviour. The study team will explain how often your child will need to visit the clinic, how the treatment will be given, and what other assessments will be involved, as well as the total length of time your child will be involved in the study.
Potenzielle Risiken und Vorteile
Standorte (1)
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Häufige Fragen
What is a 'faecal microbiota transplant'?
It's a way to put healthy gut bacteria from a donor into another person to try and improve their gut health and potentially other health conditions.
Will this treatment cure autism?
This is an exploratory study to see if the treatment helps manage some symptoms. It's not expected to be a cure for autism.
What does 'Phase II' mean for a clinical trial?
Phase II trials are early studies that aim to see if a treatment works and is safe. More research would be needed after this stage.
How will the doctors know if the treatment is working?
They will use a specific test to measure changes in autism symptoms and will ask parents to fill out questionnaires about their child's health and behaviour.
Are there any side effects from this treatment?
As with any medical treatment, there can be side effects. The study team will monitor your child closely and explain all known or potential risks.
Wie Sie mehr erfahren können
Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.
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