AuthorisedTherapeutic exploratory (Phase II)Interventional

FELICITA - A proof of concept study: open label phase IIa trial evaluating the effect and safety of transplantation of fecal microbiota in children with autism spectrum disorders and gastrointestinal symptoms

The FELICITA study is a research project exploring a new way to help children with autism who experience digestive issues like tummy aches or constipation. It's looking at a treatment called a 'stool transplant', which involves giving healthy gut bacteria from a donor. The main goal is to see if this treatment can significantly reduce digestive problems in these children over 18 weeks. Researchers will also be checking if it helps with autism symptoms and general well-being. This is an early-stage study, meaning it's one of the first times this treatment is being tested in this specific group of children to see if it's safe and potentially helpful.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

07 May 2025

Austistic spectrum disorder

What is this study about?

The FELICITA study is designed to explore a new treatment for children who have both autism spectrum disorder and tummy problems. Many children with autism also experience issues like diarrhoea, constipation, tummy pain, indigestion, and reflux. This study wants to find out if transplanting healthy gut bacteria, taken from a donor and given as an enema, can improve these digestive symptoms.

The main thing the researchers want to measure is how much the children's tummy problems improve. They will ask parents to rate their child's digestive symptoms using a special questionnaire over 18 weeks, and they are hoping to see a big reduction in these problems. They will also be looking at other important things, like whether the treatment has any impact on the children’s autism symptoms and their overall quality of life. Safety is very important, so they will carefully track any side effects.

This study is called a 'proof of concept' or 'Phase IIa' study. This means it's an early-stage trial to see if the treatment works and is safe in a small group of people, before moving on to larger studies. The aim is to gather information to decide if this type of treatment is promising enough to investigate further for children with autism and digestive issues.

Key takeaways

The FELICITA study is exploring a new treatment (stool transplant) for digestive problems in children with autism.
The main aim is to see if tummy issues improve over 18 weeks.
Researchers will also check for changes in autism symptoms and overall well-being.
Participation involves receiving the treatment and attending appointments over about a year.
This is an early-stage study to test safety and potential effectiveness.

Who may be eligible?

Currently, the study description does not specify age limits for children to join. This means that children of any age who have autism and digestive problems might be considered.

The study is open to both boys and girls.

To find out if your child could take part, you would need to speak with the study team or your doctor. They would check specific health details and criteria to make sure the study is a good fit for your child and that it would be safe for them to participate.

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.

Does my child have a diagnosis of autism spectrum disorder?
Does my child experience ongoing digestive problems like tummy pain, diarrhoea, or constipation?
Am I, as a parent, able to complete questionnaires about my child's health?
Am I open to my child receiving a 'stool transplant' as an enema?
Am I able to commit to the study's appointments and follow-up for about a year?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will receive a 'stool transplant' as an enema. This involves healthy bacteria from a donor being given to your child. Researchers will closely monitor your child over a period that lasts for about a year. You, as a parent, will be asked to complete questionnaires about your child's tummy symptoms and overall health at different times over 18 weeks, and then again at 24 weeks and 12 months. A doctor will check for any side effects at various points (day 0, day 5, week 4, week 18, week 24, and month 12). A psychologist will also assess your well-being as a caregiver at certain times (week 0, 4, 18, 24, and month 12). You'll also be asked to keep track of your child's stool consistency for short periods. The overall commitment lasts for 12 months.

Potential risks and benefits

Taking part in this study might offer a potential benefit if the 'stool transplant' helps improve your child's tummy problems and overall well-being. However, as with any new treatment, there are potential risks, and side effects will be carefully monitored by the medical team. It's important to remember that this is a research study, and there's no guarantee of benefit. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is a 'stool transplant'?

A 'stool transplant' (or Faecal Microbiota Transplant - FMT) involves taking healthy gut bacteria from a screened donor's stool and transferring them into another person's gut, usually to help improve their digestive health.

How is the 'stool transplant' given?

In this study, the 'stool transplant' will be given to your child as an enema, which means it will be introduced into their rectum.

Will this treatment cure autism?

No. This study is mainly focused on improving digestive problems in children with autism. While researchers will also observe any changes in autism symptoms, the primary goal is about gut health, not a cure for autism.

What kind of tummy problems are being looked at?

The study is looking at common digestive issues like diarrhoea, constipation, tummy pain, indigestion, and reflux.

What does 'Phase IIa' mean?

Phase IIa means this is an early study to see if a treatment is safe and if it shows any signs of working for a specific condition. It's usually done with a small group of people.