P1015 - FMT TREATMENT IN ASD CHILDREN WITH GASTROINTESTINAL DYSFUNCTION : A MULTICENTER RANDOMIZED CONTROLLED DOUBLE-BLIND STUDY

P1015

FMT TREATMENT IN ASD CHILDREN WITH GASTROINTESTINAL DYSFUNCTION : A MULTICENTER RANDOMIZED CONTROLLED DOUBLE-BLIND STUDY

L. Huang^1,*, R. yang¹, H. qin²

¹shanghai tenth people's hospital, ²tongji university, shanghai, China

Rationale: To demonstrate the efficacy of FMT treatment in  ASD children with gastrointestinal dysfunction : a multicenter randomized controlled double-blind study.

Methods: A total of 318 children with ASD children with gastrointestinal dysfunction were recruited from 10 hospitals in China. The experimental group and the placebo group were enrolled in a 2:1 ratio. All of them took fecall bacteria capsules orally for 4 months (took for 12 days per month, 4 capsules per day in under 6 years old children, 6 capsules per day in over 6 years old children), and then observed for 2 months, a total of 6 months, clinical data and  biological samples were collected.

Results: In fact, 9 hospitals recruited and enrolled ASD patients. The main center (Shanghai tenth People's Hospital) lost 46 patients due to COVID-19 infection factor, and 61 cases were actually enrolled; the other sub-centers enrolled 102 patients, 12 patients were lost , and actually enrolled 90 patients. Therefore, 151 patients were actually enrolled(average age was 6.97±2.55 years old), of which 105 patients were  enrolled in the experimental group, 82 were males. 23 for female. 46 patients were in the placebo group and 39 were male,7 for female.

the score of ABC scales ended in the second month  had statistical significance compared with before treatment, and continued to the sixth month. In the experimental group, 68 patients had effective ABC score decline, with an effective rate of 64.76%; in the placebo group, 20 patients had effective ABC score decline, with an effective rate of 43.5%, while the CARS scale did not have such statistical significance.

Conclusion: fecal microbiota transplantation(FMT) has a certain therapeutic effect on children with autism, but it also has a strong placebo effect,other evaluation methods should be added in the actual treatment process.

Disclosure of Interest: None declared