FMT in Children With Autism and Gastrointestinal Symptoms

NCT04246398 NA UNKNOWN

1. ASD children with gastrointestinal problems that interfere with daily routine will be recruited at the center for Autism led by Prof Zachor, and at the Pediatric Neurology \& Development Center at Shamir Medical Center. Publications in the social media- facebook and support groups for Autism will also be used. The decision whether or not to initiate any medical treatment will not be influenced by the study investigators and will be made solely by the treating doctor. 2. If possible, participants will provide informed consent after receiving a thorough explanation by the study team, as will both parents or other legal guardians. 3. Two groups randomization will be performed, group A and group B. The group randomization will be double blinded. 4. Participants randomized to group A will receive 10 capsules FMT twice a week for 3 weeks, and at week 12 followed by 3 weeks placebo twice a week. 5. Participants randomized to group B will receive 10 capsules placebo twice a week for 3 weeks and at week 12 followed by 3 weeks FMT twice a week. 6. At baseline, participants will undergo a full physical examination, vital signs, medical questionnaire, ROME III questionnaire for kids \>age4 /\>age 10, ATN-GISSI-17 questionnaire, Aut-Eat questionnaire regarding eating habbits, the Social Responsiveness Scale (SRS) and the Adaptive Behavior Assessment System (ABAS). 7. Parents/ care providers will fill a daily symptoms follow-up questionnaire at baseline 8. Fecal samples will be provided for analysis of microbiome and proteome at beseline, weeks 3,12, 15 and 6+9 months. 9. At each FMT/Placebo administration a short questionnaire asking about possible adverse events, GI symptoms, overall well-being, and medication changes will be administered

Details

Lead sponsor	Assaf Harofeh MC
Phase	NA
Status	UNKNOWN
Enrolment	50
Start date	2020-02
Completion	2022-12

Conditions

• Children With Autism

Interventions

• FMT
• FMT - placebo

Primary outcomes

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] — 3 weeks from the start of the study
  The safety of using FMT capsules in autistic children with gastrointestinal symptoms is measured by the prevalence and severity of side effects that occurred after taking the capsules, and were documented in a daily follow-up questionnaire
• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) — 15 weeks from the start of the study
  The safety of using FMT capsules in autistic children with gastrointestinal symptoms is measured by the prevalence and severity of side effects that occurred after taking the capsules, and were documented in a daily follow-up questionnaire
• Significant change in GI symptoms [efficiency] — 3 weeks from the start of the study
  effectiveness of FMT capsules in alleviation of GI symptoms in Autistic children is defined by a significant change in the Rome III questionnaire, used for diagnostic of pediatric functional GI disorders
• Significant change in GI symptoms [efficiency] — 15 weeks from the start of the study
  effectiveness of FMT capsules in alleviation of GI symptoms in Autistic children is defined by a significant change in the Rome III questionnaire, used for diagnostic of pediatric functional GI disorders
• Significant change in GI symptoms [efficiency] — 6 months from the start of the study
  effectiveness of FMT capsules in alleviation of GI symptoms in Autistic children is defined by a significant change in the Rome III questionnaire, used for diagnostic of pediatric functional GI disorders
• Significant change in GI symptoms [efficiency] — 9 months from the start of the study
  effectiveness of FMT capsules in alleviation of GI symptoms in Autistic children is defined by a significant change in the Rome III questionnaire, used for diagnostic of pediatric functional GI disorders

Countries

Israel