Fecal Microbiota Transplantation Given Two Ways for Children With Autism

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children aged 3-16 years with moderate-to-severe autism spectrum disorder. It compares faecal microbiota transplantation given by two routes with a placebo.

Age

3 to 16 years

Sex

All sexes

Disease stage

Autism spectrum disorder (DSM-5) with a CARS total score of 36 or more (moderate-to-severe autism).

Earlier treatment

No probiotic supplements in the 3 months before joining. No probiotics or prebiotics in the 3 months before enrolment. No antibiotics in the 1 month before enrolment.

Main reasons for not taking part

• Fever (axillary temperature 37.5°C (99.5 °F) or more)
• Dependent on tube feeding
• Severe gut conditions needing immediate care, such as Crohn's disease, ulcerative colitis or celiac disease
• Severe malnutrition, underweight, or severe immunodeficiency
• Monogenic disorders such as Fragile X syndrome or Rett syndrome

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 3 and 16 years old?YesNo

What the trial wants to find out

This is a single-center, randomized, double-dummy, triple-blind, placebo-controlled, three-arm parallel-group superiority trial. The study aims to compare the efficacy and safety of Fecal Microbiota Transplantation (FMT) administered via two different invasive routes-nasojejunal tube (NJT) and colonoscopy-versus a placebo control in children aged 3-16 years with moderate-to-severe Autism Spectrum Disorder (ASD). A total of 75 participants will be randomized in a 1:1:1 ratio to receive either active FMT via NJT with sham colonoscopy, active FMT via colonoscopy with sham NJT, or placebo via both routes. All participants will continue their stable behavioral interventions throughout the study. The primary outcome is the change from baseline to Week 24 in the total score of the Childhood Autism Rating Scale (CARS). Secondary outcomes include changes in other behavioral and gastrointestinal symptom scores, gut microbiota profiling, and safety assessments over 48 weeks.

The 3 groups in the trial

• Group 1 (FMT-NJT)Existing treatment, for comparison

  active FMT via nasojejunal tube + sham colonoscopy

  Treatment: ctive FMT via Nasojejunal Tube (FMT-Upper GI)

• Group 2 (FMT-C)Existing treatment, for comparison

  active FMT via colonoscopy with placement of a transendoscopic enteral tube (TET) secured at the cecum during the first session, followed by two subsequent infusions via the indwelling TET + sham nasojejunal intubation.

  Treatment: Active FMT via Colonoscopy and Transendoscopic Tube (FMT-Lower GI)

• Group 3 (Control)Placebo, for comparison

  placebo via nasojejunal tube + placebo via colonoscopy (sham procedures for both routes)

  Treatment: Placebo via Sham Procedures (Sham-Control)