FMT in Children With Autism and Gastrointestinal Symptoms
FMT in Children With Autism and Gastrointestinal Symptoms
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
About 50% of children with Autism spectrum disorder (ASD) tend to suffer from one or more
 gastrointestinal (GI) symptoms.The GI symptoms vary from constipation (~20%), diarrhea
 (~14%), Abdominal pain/discomfort (14%), bloating (12%), incontinence (12%), reflux (7.4%),
 nausia (6%) and difficult with bowel movements (6%).

 The severity of ASD is associated with the observed GI symptoms, although no cause-effect
 relationship between GI symptoms and ASD was proven so far. ASD with GI symptoms patients
 might display significant behavioral manifestations, such as anxiety, self-injury and
 aggression and these may be attributed to the GI symptoms themselves. Therefore alleviation
 of the GI symptoms could be important also for improvement of ASD.

 In addition to the possibility that the nervous system influences the gut and the GI
 symptoms, there is also the possibility that the gut and the microbiome within the gut may
 influence the central nervous system.

 Considering the findings that children with ASD have a history of using significantly more
 antibiotics and that gut permeability increases in ASD it is reasonable to assume that ASD
 patients have distinct microbiomes and gut metabolites.

 Nevertheless, perhaps changing the gut microbiome could lead to improvement in some of the
 symptoms. So far, studies on influencing ASD (behavior and GI symptoms) by addressing the gut
 microbiome are optimistic but mostly open-labeled and still inconclusive.
Inclusion Criteria:

 -  ASD Boys or girls 7 - 20 years of age

 -  suffering gastro-intestinal symptoms and/or food selectivity that interfere with daily
 routine

 -  Patients not started on immune-suppressive or anti-inflammatory medications.

 -  Women of child-bearing potential and men must agree to use adequate contraception
 (hormonal or barrier method of birth control; abstinence) prior to study entry and for
 the duration of study participation. Should a woman become pregnant or suspect she is
 pregnant while she or her partner is participating in this study, she should inform
 her treating physician immediately. Women of childbearing potential will have a urine
 pregnancy test, which must be negative, on Study Day 1, prior to receiving FMT. Men
 treated or enrolled on this protocol must also agree to use adequate contraception
 prior to the study and for 3 months after FMT.

 -  Hasn't taken antibiotics 2 days prior to 1st visit.

 -  Ability of parents or other legal guardian to understand and the willingness to sign a
 written informed consent document, including the willingness to accept risk of
 unrelated donor stool.

 -  Ability to swallow oral medications.

 Exclusion Criteria:

 -  Severe GI problems that require immediate treatment (life-threatening).

 -  recent/scheduled surgeries

 -  diagnosed as severely malnourished or underweight

 -  diagnosed with a single-gene disorder

 -  major brain malformations

 -  inflammatory bowel diseases

 -  known positive serology for celiac disease or eosinophilic esophagitis

 -  Pregnancy / breast-feeding

 -  Using immune-suppressive or anti-inflammatory medications

 -  Active or uncontrolled bacterial, viral, or fungal infection(s) requiring
 systemic therapy

 -  Delayed gastric emptying syndrome

 -  Known chronic aspiration

 -  History of significant allergy to foods

 -  Unable to swallow pills