Status:
ACTIVE_NOT_RECRUITING
Microbiota Transplant Therapy for Children With Both Autism Spectrum Disorder and Gastrointestinal Disorders
Lead Sponsor:
Gut-Brain-Axis Therapeutics Inc.
Conditions:
Autism Spectrum Disorder
Gastro-Intestinal Disorder
Eligibility:
All Genders
4-18 years
Phase:
PHASE2
Brief Summary
The investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating patients with Autism-spectrum disorder with Gastrointestinal disorders (constipation, diarrhea, and/or abdominal...
Detailed Description
For children 4 to less than \<18 years old with Autism-spectrum disorder with Gastrointestinal disorders (constipation, diarrhea, and/or abdominal pain). This will be a Phase 2 randomized controlled t...
Eligibility Criteria
Inclusion
- 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).
- GI disorder as defined below that has lasted for at least 1 year.
- No changes in medications, supplements, diet, therapies, or education in the 2 months prior to starting treatment, and no intention to change them during the clinical trial.
- General good physical health aside from gastrointestinal problems.
- At least two previous trials of "standard of care" GI treatments that did not alleviate GI symptoms (constipation, diarrhea, bloating, gas, reflux, and/or abdominal pain). Standard of care treatments include laxatives, stool softeners, enemas, suppositories, or similar medications.
Exclusion
- Antibiotics in 3 months prior to treatment (does not apply to topical antibiotics).
- Probiotics in 2 months prior to treatment, or fecal transplant in previous 12 months. Foods naturally containing probiotics such as yogurt are allowed.
- Single-gene disorder (Fragile X, etc.).
- Major brain malformation.
- Tube feeding.
- Current severe gastrointestinal problems that require immediate treatment (life-threatening).
- Severely underweight/malnourished (per physician clinical judgement).
- Unstable, poor health; seizure disorder that is not responsive to treatment or not on stable management or complex type; or other health conditions that would significantly increase their risk of adverse effects (per physician clinical judgement) including active malignancy or infection.
- Recent or scheduled surgeries.
- Ulcerative Colitis, Crohn's Disease, diagnosed Celiac Disease, Eosinophilic Gastroenteritis, or similar conditions.
- Current participation in other clinical trials.
- Females who are pregnant or who are at risk of pregnancy and sexually active with a male partner without effective birth control. We will conduct a pregnancy test on all female participants 12 years and older as part of the screening and at each clinical visit.
- a. Males who are sexually active with a female partner without highly effective birth control (IUD or birth control hormones).
- Allergy or intolerance to the study medications: vancomycin, Miralax, milk powder with soy and chocolate flavoring (which are included in MTP-101P), or the antacid. People with a known allergy or intolerance to milk, soy, or chocolate will be excluded from the study and will not participate in the tolerance test.
- Clinically significant abnormalities at baseline on blood safety tests: Comprehensive Metabolic Panel and Complete Blood Count with Differential. If there is a clinically significant result, a second test may be used to confirm that result at the physician's discretion.
- Psychotropic medication daily use - Current or within 2 months prior to treatment - which are known to interfere in gastrointestinal function.
- Evidence of significant impairment of immune system, or taking medications that can compromise the immune system, and thus increase risk if exposed to multiple-drug resistant bacteria.
- Substantially decreased kidney function, as evidenced by estimated glomerular filtration rate of \<60 mL/min/1.73 m2. This is not normally reported for children on standard laboratory metabolic panels, so in those cases we will use the National Kidney Foundations Pediatric GFR Calculator to calculate the pediatric GFR based on age/height, the BUN and serum creatinine from our standard CMP (National Kidney Foundation Inc., n.d.). This calculator uses the Creatinine-based "Bedside Schwartz" equation (2009) that seems to be the most commonly used calculation for this purpose.
- Participants who are breastfeeding.
- The rational for exclusions 1-2 is that they interfere with gut flora. The rationale for exclusions 3-4 is that those individuals are probably less likely to respond to the proposed treatment.
- The rationale for exclusions 5-9 is that those individuals are at higher risk of safety problems with MTT.
- The rational for exclusion 10 is that inclusion of people with these GI conditions would complicate analysis of the study results.
- The rational for exclusion 11 is that participation in other trials would interfere with the results of this one.
- The rationale for exclusion 12 is to avoid risk to fetuses. The rationale for exclusion 13 is to avoid known allergic reactions to study medications.
Key Trial Info
Start Date :
August 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 17 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06503978
Start Date
August 20 2024
End Date
August 17 2026
Last Update
September 25 2024
Active Locations (1)
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1
Autism/Asperger's Research Group at Arizona State University
Tempe, Arizona, United States, 85287