Autism Spectrum DisorderPhase 2NCT06503978
Microbiota Transplant Therapy for Children With Both Autism Spectrum Disorder and Gastrointestinal Disorders
A Phase 2 study testing MTP-101P, Vancomycin and Miralax in people with Autism Spectrum Disorder and Gastro-Intestinal Disorder, run by Gut-Brain-Axis Therapeutics Inc. at 1 site in United States.
Trial 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 pain). Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder, Gastro-Intestinal Disorder, Constipation
- What is being tested?
- MTP-101P, Vancomycin and Miralax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2024to 17 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 24Show fewer
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Autism/Asperger's Research Group at Arizona State University
Tempe, Arizona, 85287
About this study
Official title: Dosing Study of Microbiota Transplant Therapy for Children With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders
The investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating patients with Autism-spectrum disorder with Gastrointestinal disorders (constipation, diarrhea, and/or abdominal pain). MTT involves a combination of 14 days of oral vancomycin (an antibiotic to kill pathogenic bacteria), followed by 1 day of bowel cleanse using Miralax, followed by 5 days of high dose MTP-101P with an antacid, followed by 12 weeks of a lower maintenance dose of MTP-101P with an antacid.
Read the 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 trial to compare two dosing strategies for microbiota transplant vs. placebo.
Participants will be randomly assigned to Group A, B, C or D
Part 1: Placebo-Controlled Treatment (15 Weeks) The trial will begin with a randomized, double-blind, placebo-controlled trial which will include a 14-day treatment with oral vancomycin (or placebo), then 1 day of Miralax to cleanse the bowel of vancomycin and bacteria/feces (all participants, since its bowel-emptying effect cannot be blinded), followed by 5 days of initial high dose of MTP-101P taken daily 5 minutes after antacid, and then 12 weeks of a lower maintenance dose of MTP-101P taken daily 5 minutes after an antacid.
Group A: Real Treatment. Dose 1 Group B: Real Treatment. Dose 2 Group C: Placebo vancomycin, real Miralax, placebo MTP-101P, real antacid. Group D: Placebo vancomycin, real Miralax, placebo MTP-101P, real antacid.
Part 2: Open-Label Observation and Cross-Over (12 weeks)
Group A: Observation over the next 12 weeks (no additional treatment). Group B: Observation over the next 12 weeks (no additional treatment). Group A and B completes study at end of part 2.
Group C will receive the same dosage group A received in part 1 (Dose 1). This includes 14 days of vancomycin, Miralax, and an initial high dose of MTP-101P for 5 days taken daily 5 minutes after an antacid, and then a lower dose of MTP-101P for 12 weeks taken daily 5 minutes after antacid.
Group D will receive the same dosage group B received in part 1 (Dose 2). This includes 14 days of vancomycin, Miralax, and an initial high dose of MTP-101P for 5 days taken daily 5 minutes after an antacid, and then a lower dose of MTP-101P for 12 weeks taken daily 5 minutes after antacid.
Part 3: Follow Up Group C and D. There will be a follow-up evaluation 15 weeks post-treatment after the end of Part 2, to assess long-term efficacy and possible adverse effects.
- Being tested
- MTP-101P, Vancomycin, Miralax, Antacid, Placebo MTP-101P
- Keywords
- fecal transplant, fecal microbiota transplant
- Medical subject headings
- Autism Spectrum Disorder, Digestive System Diseases, Constipation, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
VancomycinCombination product
Oral vancomycin is an antibiotic used for treating C. difficile-associated diarrhea and staphylococcal-induced enterocolitis.
Duration: 14 Days
MiralaxCombination product
Miralax is a common over-the-counter laxative and bowel cleanse
AntacidCombination product
The antacid will be aluminum/magnesium hydroxide, 1x/day, 5 minutes before the MTP-101P. Each 5 ml consists of Aluminum Hydroxide - 200 mg, Magnesium Hydroxide - 200 mg, and Simethicone - 20 mg. If some participants cannot tolerate the aluminum/magnesium hydroxide, we will allow calcium carbonate alternatives equivalent in acid neutralizing capacity.
Duration: 12 weeks
Placebo MTP-101PCombination product
The same packaging will be used as for MTP-101P, but the sachets will contain a freeze-dried mixture of normal saline containing 10% Trehalose.
Duration: 12 weeks
Placebo VancomycinCombination product
Same packaging and liquid carrier and flavoring used as for the oral vancomycin, but no vancomycin.
Duration: 14 days
| Study group | Role | What they receive |
|---|---|---|
| Group A: Treatment (Dose 1) | Experimental | Part 1: Blinded Treatment (15 weeks)
Vancomycin, Miralax, Antacid, MTP-101P Receives: Combination Product: MTP-101P; Combination Product: Vancomycin; Combination Product: Miralax; Combination Product: Antacid |
| Group B: Treatment (Dose 2) | Experimental | Part 1: Blinded Treatment (15 weeks)
Vancomycin, Miralax, Antacid, MTP-101P Receives: Combination Product: MTP-101P; Combination Product: Vancomycin; Combination Product: Miralax; Combination Product: Antacid |
| Group C: Placebo | Placebo comparator | Part 1: Blinded Placebo (15 weeks)
Placebo Vancomycin, Real Miralax, Real Antacid, Placebo MTP-101P Receives: Combination Product: Miralax; Combination Product: Placebo MTP-101P; Combination Product: Placebo Vancomycin |
| Group D: Placebo | Placebo comparator | Part 1: Blinded Placebo (15 weeks)
Placebo Vancomycin, Real Miralax, Real Antacid, Placebo MTP-101P Receives: Combination Product: Miralax; Combination Product: Placebo MTP-101P; Combination Product: Placebo Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Screening (0-120 days prior to Baseline) vs Baseline (0-30 days prior to treatment) vs End of Treatment (Day 104)
Secondary outcomes (9)
Gastrointestinal Symptom Rating Scale (GSRS)
An assessment of GI symptoms based on 15 questions, which are then scored in five domains (abdominal pain, reflux, indigestion, diarrhea, and constipation). Symptoms are rated on a 7-point Likert scale including no discomfort at all (1), slight discomfort (2), mild discomfort (3), moderate discomfort (4), moderately severe discomfort (5), severe discomfort (6), and very severe discomfort (7).
Measured: Baseline (0-30 days prior to treatment) VS Day 14, 28,56,84 and 104
Clinical Global Impression - Gastrointestinal (CGI-GI)
This assessment is conducted by the study physician and assess the severity of GI symptoms on a 7-point scale. The severity scale rates the severity of the patient's illness including normal, not at all ill (1), borderline mentally ill (2), mildly ill (3), moderately ill (4), markedly ill (5), severely ill (6), among the most extremely ill patients (7).
Measured: Baseline (0-30 days prior to treatment) VS End of Treatment (Day 104)
Clinical Global Impression - Autism (CGI-A)
This assessment is conducted by the study physician and assess the severity of Autism Symptoms on a 7-point scale. The severity scale rates the severity of the patient's illness including normal, not at all ill (1), borderline mentally ill (2), mildly ill (3), moderately ill (4), markedly ill (5), severely ill (6), among the most extremely ill patients (7).
Measured: Baseline (0-30 days prior to treatment) VS End of Treatment (Day 104)
National Survey on treatment Effectiveness for Autism (NSTEA)
Assess the effectiveness of MTT on overall benefit (no benefit (0)/slight benefit(1)/moderate benefit (2)/good benefit (3)/great benefit (4)).
Measured: End of Treatment (Day 104)
Social Responsiveness Scale (SRS 2)
65-item scale that assesses social impairments, a core issue in autism, including social awareness, social information processing, capacity for reciprocal social communication, social anxiety/avoidance, and autistic preoccupations and traits.
Measured: Baseline (0-30 days prior to treatment) VS End of Treatment (Day 104)
Aberrant Behaviour Checklist (ABC-2)
assesses problem behaviors in five areas common in individuals with ASD, including irritability, social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech.
Measured: Baseline (0-30 days prior to treatment) VS End of Treatment (Day 104)
CAAAS (subscale on GI symptoms)
This tool assesses both core ASD symptoms and a comprehensive list of common co-occurring symptoms in ASD, including gastrointestinal, behavioral, mental health, and physical health symptoms.
9-point severity scale from "none" to "major". There is also a "change"
Measured: Baseline (0-30 days prior to treatment) VS Day 14, 28,56,84 and 104
Comprehensive Assessment of Autism and Associated Symptoms (CAAAS)
This tool assesses both core ASD symptoms and a comprehensive list of common co-occurring symptoms in ASD, including gastrointestinal, behavioral, mental health, and physical health symptoms.
9-point severity scale from "none" to "major". There is also a "change"
Measured: Baseline (0-30 days prior to treatment) VS Day 14, 28,56,84 and 104
Vineland Adaptive Behavior Scale -Third Edition (Vineland 3)
Comprehensive form consisting of 381 items covering three domains (Communication, Daily Living Skills, and Socialization) and the Maladaptive Behavior subscale (44 items).
Measured: Baseline (0-30 days prior to treatment) VS End of Treatment (Day 104)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start20 Aug 2024
- Primary completion17 Jul 2025 (estimated)
- Study completion17 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gut-Brain-Axis Therapeutics Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503978
- Sponsor's protocol ID
- WCG IRB #20242031
- Status last verified
- Sep 2024
- First submitted
- 10 Jul 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosing Study of Microbiota Transplant Therapy for Children With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders
- ClinicalTrials.gov ID
- NCT06503978
- Acronym / sponsor ID
- WCG IRB #20242031
- Keywords
- fecal transplant, fecal microbiota transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gut-Brain-Axis Therapeutics Inc.University, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 17 Jul 2025 (estimated)
- Study completion
- 17 Aug 2026 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating patients with Autism-spectrum disorder with Gastrointestinal disorders (constipation, diarrhea, and/or abdominal pain). MTT involves a combination of 14 days of oral vancomycin (an antibiotic to kill pathogenic bacteria), followed by 1 day of bowel cleanse using Miralax, followed by 5 days of high dose MTP-101P with an antacid, followed by 12 weeks of a lower maintenance dose of MTP-101P with an antacid.
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 trial to compare two dosing strategies for microbiota transplant vs. placebo.
Participants will be randomly assigned to Group A, B, C or D
Part 1: Placebo-Controlled Treatment (15 Weeks) The trial will begin with a randomized, double-blind, placebo-controlled trial which will include a 14-day treatment with oral vancomycin (or placebo), then 1 day of Miralax to cleanse the bowel of vancomycin and bacteria/feces (all participants, since its bowel-emptying effect cannot be blinded), followed by 5 days of initial high dose of MTP-101P taken daily 5 minutes after antacid, and then 12 weeks of a lower maintenance dose of MTP-101P taken daily 5 minutes after an antacid.
Group A: Real Treatment. Dose 1 Group B: Real Treatment. Dose 2 Group C: Placebo vancomycin, real Miralax, placebo MTP-101P, real antacid. Group D: Placebo vancomycin, real Miralax, placebo MTP-101P, real antacid.
Part 2: Open-Label Observation and Cross-Over (12 weeks)
Group A: Observation over the next 12 weeks (no additional treatment). Group B: Observation over the next 12 weeks (no additional treatment). Group A and B completes study at end of part 2.
Group C will receive the same dosage group A received in part 1 (Dose 1). This includes 14 days of vancomycin, Miralax, and an initial high dose of MTP-101P for 5 days taken daily 5 minutes after an antacid, and then a lower dose of MTP-101P for 12 weeks taken daily 5 minutes after antacid.
Group D will receive the same dosage group B received in part 1 (Dose 2). This includes 14 days of vancomycin, Miralax, and an initial high dose of MTP-101P for 5 days taken daily 5 minutes after an antacid, and then a lower dose of MTP-101P for 12 weeks taken daily 5 minutes after antacid.
Part 3: Follow Up Group C and D. There will be a follow-up evaluation 15 weeks post-treatment after the end of Part 2, to assess long-term efficacy and possible adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Group A: Treatment (Dose 1) | Experimental | Combination Product: MTP-101P, Combination Product: Vancomycin, Combination Product: Miralax, Combination Product: AntacidPart 1: Blinded Treatment (15 weeks) Vancomycin, Miralax, Antacid, MTP-101P |
| Group B: Treatment (Dose 2) | Experimental | Combination Product: MTP-101P, Combination Product: Vancomycin, Combination Product: Miralax, Combination Product: AntacidPart 1: Blinded Treatment (15 weeks) Vancomycin, Miralax, Antacid, MTP-101P |
| Group C: Placebo | Placebo comparator | Combination Product: Miralax, Combination Product: Placebo MTP-101P, Combination Product: Placebo VancomycinPart 1: Blinded Placebo (15 weeks) Placebo Vancomycin, Real Miralax, Real Antacid, Placebo MTP-101P |
| Group D: Placebo | Placebo comparator | Combination Product: Miralax, Combination Product: Placebo MTP-101P, Combination Product: Placebo VancomycinPart 1: Blinded Placebo (15 weeks) Placebo Vancomycin, Real Miralax, Real Antacid, Placebo MTP-101P |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTP-101PMTP-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. | Combination product | Group A: Treatment (Dose 1), Group B: Treatment (Dose 2) |
| VancomycinOral vancomycin is an antibiotic used for treating C. difficile-associated diarrhea and staphylococcal-induced enterocolitis. Duration: 14 Days | Combination product | Group A: Treatment (Dose 1), Group B: Treatment (Dose 2) |
| MiralaxMiralax is a common over-the-counter laxative and bowel cleanse | Combination product | Group A: Treatment (Dose 1), Group B: Treatment (Dose 2), Group C: Placebo, Group D: Placebo |
| AntacidThe antacid will be aluminum/magnesium hydroxide, 1x/day, 5 minutes before the MTP-101P. Each 5 ml consists of Aluminum Hydroxide - 200 mg, Magnesium Hydroxide - 200 mg, and Simethicone - 20 mg. If some participants cannot tolerate the aluminum/magnesium hydroxide, we will allow calcium carbonate alternatives equivalent in acid neutralizing capacity. Duration: 12 weeks | Combination product | Group A: Treatment (Dose 1), Group B: Treatment (Dose 2) |
| Placebo MTP-101PThe same packaging will be used as for MTP-101P, but the sachets will contain a freeze-dried mixture of normal saline containing 10% Trehalose. Duration: 12 weeks | Combination product | Group C: Placebo, Group D: Placebo |
| Placebo VancomycinSame packaging and liquid carrier and flavoring used as for the oral vancomycin, but no vancomycin. Duration: 14 days | Combination product | Group C: Placebo, Group D: Placebo |
Primary outcome
Childhood Autism Rating Scale (CARS-2)
Time frame: Baseline (0-30 days prior to treatment) vs End of Treatment (Day 104)
A 15-item scale that can be used to both diagnose autism and ASD and to assess the overall severity of symptoms
Daily Stool Record (DSR)
Time frame: Screening (0-120 days prior to Baseline) vs Baseline (0-30 days prior to treatment) vs End of Treatment (Day 104)
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.
9 secondary outcomes
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Baseline (0-30 days prior to treatment) VS Day 14, 28,56,84 and 104
Clinical Global Impression - Gastrointestinal (CGI-GI)
Time frame: Baseline (0-30 days prior to treatment) VS End of Treatment (Day 104)
Clinical Global Impression - Autism (CGI-A)
Time frame: Baseline (0-30 days prior to treatment) VS End of Treatment (Day 104)
National Survey on treatment Effectiveness for Autism (NSTEA)
Time frame: End of Treatment (Day 104)
Social Responsiveness Scale (SRS 2)
Time frame: Baseline (0-30 days prior to treatment) VS End of Treatment (Day 104)
Aberrant Behaviour Checklist (ABC-2)
Time frame: Baseline (0-30 days prior to treatment) VS End of Treatment (Day 104)
CAAAS (subscale on GI symptoms)
Time frame: Baseline (0-30 days prior to treatment) VS Day 14, 28,56,84 and 104
Comprehensive Assessment of Autism and Associated Symptoms (CAAAS)
Time frame: Baseline (0-30 days prior to treatment) VS Day 14, 28,56,84 and 104
Vineland Adaptive Behavior Scale -Third Edition (Vineland 3)
Time frame: Baseline (0-30 days prior to treatment) VS End of Treatment (Day 104)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MTP-101P, Vancomycin and Miralax in people with Autism Spectrum Disorder and Gastro-Intestinal Disorder, run by Gut-Brain-Axis Therapeutics Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childhood Autism Rating Scale (CARS-2) (time frame: Baseline (0-30 days prior to treatment) vs End of Treatment (Day 104)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.