Microbiota Transfer Therapy for Adults With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Psychiatric, Psychiatric, Gastrointestinal, Autism, Digestive Disease |
| Therapuetic Areas: | Gastroenterology, Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 1/26/2018 |
| Start Date: | January 4, 2018 |
| End Date: | September 1, 2021 |
| Contact: | James B. Adams, PhD |
| Email: | jim.adams@asu.edu |
| Phone: | 480 965 3316 |
This is a clinical trial of Microbiota Transplant Therapy (MTT) for adults with autism
spectrum disorders (ASD) who have gastrointestinal problems.
Previous research has shown that individuals with ASD have a low diversity of gut bacteria,
and low diversity is generally associated with poor gastrointestinal (GI) health. We
previously found that MTT therapy for children with ASD and GI symptoms was helpful in
reducing their GI symptoms, reducing their ASD symptoms, and increasing their diversity of
gut bacteria.
This clinical trial will investigate the hypothesis that MTT therapy will be helpful for
adults with ASD who have GI symptoms.
spectrum disorders (ASD) who have gastrointestinal problems.
Previous research has shown that individuals with ASD have a low diversity of gut bacteria,
and low diversity is generally associated with poor gastrointestinal (GI) health. We
previously found that MTT therapy for children with ASD and GI symptoms was helpful in
reducing their GI symptoms, reducing their ASD symptoms, and increasing their diversity of
gut bacteria.
This clinical trial will investigate the hypothesis that MTT therapy will be helpful for
adults with ASD who have GI symptoms.
For adults ages 18-60 years with ASD and gastrointestinal problems, the investigators propose
a Phase 2 clinical trial to evaluate the safety and efficacy of MTT. The study will also
determine if longer treatment is beneficial, and to conduct a longer observation after
treatment stops to determine long-term safety and efficacy. The three parts of this trial are
described below.
Part 1: Placebo-Controlled Treatment The trial will begin with a randomized, double-blind,
placebo-controlled trial which will include a 2-week treatment with oral vancomycin (or
placebo), then 1 day of Moviprep to cleanse the bowel of vancomycin and bacteria/feces (all
participants, since its bowel-emptying effect cannot be blinded), followed by oral
administration of Full Spectrum Microbiota (FSM) or placebo. An initial high dose of FSM (or
placebo) for two days will be followed by a lower maintenance dose of FSM (or placebo) for 8
weeks.
Part 2 Extension and Cross-Over
- For the treatment group from Part 1, there will be an 8-week extension of the
maintenance dose, to determine if longer treatment has additional benefits.
- For the placebo group from Part 1, they will receive MoviPrep, an initial high dose of
FSM for 2 days, and then a lower dose of FSM for 8 weeks (similar to the treatment group
in Part 1, but without the vancomycin). This will help us determine if pre-treatment
with vancomycin is needed or not.
Part 3: Follow-up There will be follow-up evaluations at 6, 12, and 18 months after treatment
is stopped, to assess long-term efficacy and possible adverse effects.
a Phase 2 clinical trial to evaluate the safety and efficacy of MTT. The study will also
determine if longer treatment is beneficial, and to conduct a longer observation after
treatment stops to determine long-term safety and efficacy. The three parts of this trial are
described below.
Part 1: Placebo-Controlled Treatment The trial will begin with a randomized, double-blind,
placebo-controlled trial which will include a 2-week treatment with oral vancomycin (or
placebo), then 1 day of Moviprep to cleanse the bowel of vancomycin and bacteria/feces (all
participants, since its bowel-emptying effect cannot be blinded), followed by oral
administration of Full Spectrum Microbiota (FSM) or placebo. An initial high dose of FSM (or
placebo) for two days will be followed by a lower maintenance dose of FSM (or placebo) for 8
weeks.
Part 2 Extension and Cross-Over
- For the treatment group from Part 1, there will be an 8-week extension of the
maintenance dose, to determine if longer treatment has additional benefits.
- For the placebo group from Part 1, they will receive MoviPrep, an initial high dose of
FSM for 2 days, and then a lower dose of FSM for 8 weeks (similar to the treatment group
in Part 1, but without the vancomycin). This will help us determine if pre-treatment
with vancomycin is needed or not.
Part 3: Follow-up There will be follow-up evaluations at 6, 12, and 18 months after treatment
is stopped, to assess long-term efficacy and possible adverse effects.
Inclusion Criteria:
1. Adult aged 18-60 years
2. Diagnosis of autism per both the Autism Diagnostic Interview - Revised (ADI-R) and the
Childhood Autism Rating Scale 2 (CARS-2).
3. GI disorder as defined below that has lasted for at least 3 years.
4. No changes in medications, supplements, diet, therapies, or education in last 3
months, and no intention to change them during the clinical trial.
5. General good physical health aside from gastrointestinal problems
6. Neurotypical adult observer (such as parent, guardian, or sibling) who observes adult
for at least 4 hours/week who can serve as an Evaluator to complete questionnaires on
their symptoms with the assistance of the Participant as much as they are able.
7. Ability to swallow pills (without chewing)
Exclusion Criteria:
1. Antibiotics in last 3 months
2. Probiotics in last 2 months, or fecal transplant in last 12 months
3. Single-gene disorder (Fragile X, etc.)
4. Major brain malformation
5. Tube feeding
6. Severe gastrointestinal problems that require immediate treatment (life-threatening)
7. Ulcerative Colitis, Crohn's Disease, diagnosed Celiac Disease, Eosinophilic
Gastroenteritis, or similar conditions
8. Severely underweight/malnourished
9. Recent or scheduled surgeries
10. Current participation in other clinical trials
11. Females who are pregnant or who are sexually active without effective birth control.
We will conduct a urine pregnancy test on all female participants as part of the
screening and at each clinical visit.
12. Allergy or intolerance to vancomycin or MoviPrep
13. Clinically significant abnormalities at baseline on two blood safety tests:
Comprehensive Metabolic Panel and Complete Blood Count with Differential.
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