FMT in Children With Autism and Gastrointestinal Symptoms

NCT04246398 | Unknown

• 1 other identifier: 0052-19-ASF
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.Two groups randomization will be performed, group A and group B. The group randomization will be double blinded.
4. 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. 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. 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. 7.Parents/ care providers will fill a daily symptoms follow-up questionnaire at baseline
8. 8.Fecal samples will be provided for analysis of microbiome and proteome at beseline, weeks 3,12, 15 and 6+9 months.
9. 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

Keywords

Fecal microbiota transplant; autism spectrum disorder; children

Outcome Measures

Primary Outcomes (6)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  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

  3 weeks from the start of the study

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])

  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

  15 weeks from the start of the study

• Significant change in GI symptoms [efficiency]

  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

  3 weeks from the start of the study

• Significant change in GI symptoms [efficiency]

  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

  15 weeks from the start of the study

• Significant change in GI symptoms [efficiency]

  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

  6 months from the start of the study

• Significant change in GI symptoms [efficiency]

  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

  9 months from the start of the study

Secondary Outcomes (10)

• Change in food selection [efficiency]

  12 weeks from the start of the study

• Change in food selection [efficiency]

  6 months from the start of the study

• Change in food selection [efficiency]

  9 months from the start of the study

• Improving ASD symptoms [efficiency]

  3 months from the start of the study

• Improving ASD symptoms [efficiency]

  6 months from the start of the study

Study Arms (2)

Fecal microbiota transplant (FMT)

EXPERIMENTAL

10 capsules per dose for 6 consecutive weeks, twice a week, for a total of 120 capsules. Each inoculum will be prepared from the feces of 1 donor and a dose of 10 capsules contains sieved, concentrated material derived from a mean of 10 grams of fecal matter. Donors are healthy, nonpregnant adults aged 18 to 50 years, taking no medications, and with a normal body mass index (18.5-25 \[calculated as weight in kilograms divided by height in meters squared\]).

Other: FMT

placebo

PLACEBO COMPARATOR

Placebo capsules will consist of a combination of saline/glycerol (same vehicle as FMT capsules). The inner capsules is dark (green colored), so the general appearance of the capsules is the same to the people who do not prepare them.

Other: FMT - placebo

Interventions

FMT OTHER

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.

Also known as: Fecal microbiota transplant

Fecal microbiota transplant (FMT)

FMT - placebo OTHER

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.

placebo

Eligibility Criteria

• Age: 7 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf Harofeh MC: lead

Study Sites (1)

Assaf-HarofehMC

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Ilan Youngster, M.D

CONTACT

0506301191; youngsteri@shamir.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.Ilan Youngster, Head, The Center for Translational Microbiome Research at Shamir Medical Center

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 29, 2020
• Study Start: February 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)