Familial Fecal Microbiota Transplant for the Treatment of Subjects With Autism Spectrum Disorders
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorProgenaBiome
About this trial
This is an open-label clinical trial to evaluate the benefits of familial fecal microbiota transplant following a 6-week treatment with Vancomycin in adult subjects with ASD for treatment of social deficits and language delays.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject at least six years of age.
Subject has confirmed diagnosis of ASD based on the DSM-V.
Subject with ASD whose parents/caregiver/guardian/LAR can complete informed consent process.
A reliable parent or caregiver who can report the side effects and communicate effectively with the research team.
Disqualifiers
Female subjects who are pregnant, nursing, or intend to become pregnant during the study period.
Subjects whose caregivers are unable/unwilling to cooperate with the protocol requirements.
Subject will be excluded who are suffering with Rett syndrome and Childhood Disintegrative Disorder.
Other serious co-morbid medical disorders affecting brain function and behavior, including uncontrolled seizures.
Trial design
Design model
Single group
Treatments tested in this trial
Fecal Microbiota Transplant
Biological/VaccineFMT utilizing stool from first degree relatives
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Autism SubjectsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ATEC
Number of participants with changes in the Autism Treatment Evaluation Checklist scores
Time frame
52 Weeks2
QoLA
Number of participants with changes in Quality of Life Autism scores
Time frame
52 Weeks3
CARS-2
Number of participants with changes in Childhood Autism Rating Scale 2 scores
Time frame
52 Weeks4
SRS-2
Number of patients with changes in SRS-2 scores
Time frame
52 weeksSecondary outcomes
1
Shannon Diversity Index
Changes in Shannon Diversity index compared between pre and post FMT scores
Time frame
52 Weeks2
Microbiome changes
Number of subjects with changes to microbiome relative abundance and composition
Time frame
52 weeksOther outcomes
1
Adverse Events
Number of participants with grade III or higher adverse events
Time frame
52 Weeks2
Serious Adverse Events
Number of participants with serous adverse events
Time frame
52 WeeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
ProgenaBiome
Lead sponsor
Ventura Clinical Trials
Collaborator
Microbiome Research Foundation
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: