Loading search results

Outcome Measures

Primary Outcomes (2)

Childhood Autism Rating Scale (CARS-2)
A 15-item scale that can be used to both diagnose autism and ASD and to assess the overall severity of symptoms
Baseline (0-30 days prior to treatment) vs End of Treatment (Day 104)
Daily Stool Record (DSR)
Participants will report the number of abnormal events during a 14 day period. An event includes no bowel movement during 1 day, unusually hard stool (Bristol Stool Form type 1-2), unusually soft stool (Bristol Stool Form type 6-7), four or more bowel movements in 1 day, abdominal pain, or use of GI medication. The units are number of events regardless of type of event.
Screening (0-120 days prior to Baseline) vs Baseline (0-30 days prior to treatment) vs End of Treatment (Day 104)

Secondary Outcomes (9)

Study Arms (4)

Group A: Treatment (Dose 1)

EXPERIMENTAL

Part 1: Blinded Treatment (15 weeks) Vancomycin, Miralax, Antacid, MTP-101P

Combination Product: MTP-101PCombination Product: VancomycinCombination Product: MiralaxCombination Product: Antacid

Group B: Treatment (Dose 2)

EXPERIMENTAL

Part 1: Blinded Treatment (15 weeks) Vancomycin, Miralax, Antacid, MTP-101P

Combination Product: MTP-101PCombination Product: VancomycinCombination Product: Miralax

Interventions

MTP-101PCombination product

MTP-101P is comprised of standardized dose of total fecal microbiota purified from the stool of healthy donors. Donors are carefully screened via health status questionnaires, physical examinations, reviews of comprehensive medical history, clinical laboratory evaluations, serologic and genomic tests for infectious diseases and metabolic health, and stool-related pathogen testing. The material from the donors is purified to remove the majority of non-bacterial material, washed, lyophilized, and provided to the patient in a sachet contained within a mixing bottle.

Group A: Treatment (Dose 1)Group B: Treatment (Dose 2)

VancomycinCombination product

Eligibility Criteria

Age4 Years - 18 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Child aged 4 to \< 18 years. This is 1 year younger than our previous study of MTT for children with ASD (IND 19048, protocol 2), because there were minimal adverse effects in that study, and earlier intervention may be more beneficial.
Diagnosis of autism per the Childhood Autism Rating Scale 2 (CARS-2) and either the Autism Diagnostic Interview-Revised (ADI-R) or the Autism Diagnostic Observation Schedule 2 (ADOS 2).

MeSH Terms

Conditions

Autism Spectrum DisorderDigestive System DiseasesConstipationDiarrhea

Interventions

Vancomycinpolyethylene glycol 3350Antacids

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type

interventional

Phase

phase 2

Allocation

RANDOMIZED

Masking

QUADRUPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR

Masking Details

Participants, Investigators and outcome assessors were all blinded. Only the Pharmacist distributing the medication knew the randomization code.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Part 1: Randomized, Double-Blinded, Placebo-Controlled with 2 Treatment groups and 2 Placebo Groups (15 weeks) Part 2: Open-Label Observation and Cross-over or Treatment Part 3: Follow Up (Group B Only)

Sponsor Type

OTHER

Responsible Party

SPONSOR

Microbiota Transplant Therapy for Children With Both Autism Spectrum Disorder and Gastrointestinal Disorders

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (9)

Study Arms (4)

Group A: Treatment (Dose 1)

Group B: Treatment (Dose 2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Group C: Placebo

Group D: Placebo

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (9)

Study Arms (4)

Group A: Treatment (Dose 1)

Group B: Treatment (Dose 2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Group C: Placebo

Group D: Placebo

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations