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FMT in Children With Autism and Gastrointestinal Symptoms

NCT04246398 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-02-05

No results posted yet for this study

Summary

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

Conditions

  • Children With Autism

Interventions

OTHER

FMT

Participants will be asked to fast for 4 hours prior to and 1 hour following capsule intake. Each capsule will be taken with a sip of water, Capsules must not be crushed, chewed, or dissolved Participants will be evaluated for 15 minutes immediately following capsule administration.

OTHER

FMT - placebo

Participants will be asked to fast for 4 hours prior to and 1 hour following capsule intake. Each capsule will be taken with a sip of water, Capsules must not be crushed, chewed, or dissolved Participants will be evaluated for 15 minutes immediately following capsule administration.

Sponsors & Collaborators

  • Assaf Harofeh MC

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
7 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-29
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04246398 on ClinicalTrials.gov