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| Name | Class |
|---|---|
| Northern Arizona University | OTHER |
| University of Arizona | OTHER |
| University of Minnesota | OTHER |
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This is an open-label clinical trial to investigate a combination therapy for treating gastrointestinal problems in children with autism spectrum disorders.
The combination therapy includes beneficial bacteria.
This is an open-label clinical trial to evaluate the safety, tolerability, and feasibility of a combination therapy to treat gastrointestinal problems in children with autism spectrum disorders.
It involves a combination therapy including beneficial bacteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Group | Experimental | This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen. |
|
| Rectal Group | Experimental | This group will receive some treatments rectally and some orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral Vancomycin | Drug | an antibiotic |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Symptom Responsiveness Scale (GSRS) | The GSRS is a measure of gastrointestinal symptoms. It includes 15 questions, rated on a Likert scale of 1-7, from no symptoms to severe symptoms, respectively (i.e., higher is worse). We report an average score for all 15 questions, so the possible range for the average score is also 1-7. | Baseline and 10 weeks (end of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Parent Global Impressions-Revised (PGI-R) | The PGI-R is a rating of change of 18 autism symptoms compared to baseline, with each symptom rated on a Likert scale from -3 (much worse) to zero (no change) to +3 (much better). We report the average change of the 18 symptoms, so the possible range is from -3 to +3. | Baseline and 10 weeks (end of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James B Adams, PhD | Arizona State University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33087514 | Result | Kang DW, Adams JB, Vargason T, Santiago M, Hahn J, Krajmalnik-Brown R. Distinct Fecal and Plasma Metabolites in Children with Autism Spectrum Disorders and Their Modulation after Microbiota Transfer Therapy. mSphere. 2020 Oct 21;5(5):e00314-20. doi: 10.1128/mSphere.00314-20. | |
| 30967657 | Result | Kang DW, Adams JB, Coleman DM, Pollard EL, Maldonado J, McDonough-Means S, Caporaso JG, Krajmalnik-Brown R. Long-term benefit of Microbiota Transfer Therapy on autism symptoms and gut microbiota. Sci Rep. 2019 Apr 9;9(1):5821. doi: 10.1038/s41598-019-42183-0. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Group | This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen. oral Vancomycin: an antibiotic MoviPrep: a bowel cleanse Prilosec: a stomach acid suppressan human fecal material; processed, frozen administered orally: human fecal material; processed, frozen, administered orally |
| FG001 | Rectal Group | This group will receive some treatments rectally and some orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen. oral Vancomycin: an antibiotic MoviPrep: a bowel cleanse Prilosec: a stomach acid suppressan human fecal material; processed, frozen; administered orally and rectally: human fecal material; processed, frozen; administered orally and rectally |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One of the participants in the oral group changed to the rectal group after nausea/vomiting with the initial oral dose. So, 13/5 changed to 12/6
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Group | This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen. oral Vancomycin: an antibiotic MoviPrep: a bowel cleanse Prilosec: a stomach acid suppressan human fecal material; processed, frozen administered orally: human fecal material; processed, frozen, administered orally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gastrointestinal Symptom Responsiveness Scale (GSRS) | The GSRS is a measure of gastrointestinal symptoms. It includes 15 questions, rated on a Likert scale of 1-7, from no symptoms to severe symptoms, respectively (i.e., higher is worse). We report an average score for all 15 questions, so the possible range for the average score is also 1-7. | We report the data on all participants, regardless of how the initial dose of bacteria was administered (oral or rectal). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 10 weeks (end of treatment) |
|
|
During the 10 weeks of treatment, and the 8 weeks of follow-up (18 weeks total).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Groups | We report the data on 18 participants, regardless of how the initial dose of bacteria was administered. The reason is that all but one of the adverse events occurred during the vancomycin phase, which was common to both groups, and occurred before the randomization to receive the microbiota either orally or rectally. The only exception is one participant who had initial nausea/vomiting upon receiving the initial oral dose of microbiota, and they were switched from the oral group to the rectal group, which they tolerated without incident. There were no adverse effects from the microbiota. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | One participant experienced a rash on their body after taking the vancomycin (flavored with natural orange). The vancomycin was stopped, the rash disappeared, and a non-flavored vancomycin was then administered without adverse effect |
Small study, open-label design, but able to demonstrate safety and possible efficacy.
Dosage and duration not optimized, so adjustments in dosage and/or duration may improve results.
Therapy involved 4 medications; not clear if all needed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Adams | Arizona State University | 480 965 3316 | jim.adams@asu.edu |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| C520497 | MoviPrep |
| D009853 | Omeprazole |
| D017348 | Microscopy, Electron, Scanning Transmission |
| D005615 | Freezing |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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| MoviPrep |
| Drug |
a bowel cleanse |
|
| Prilosec | Drug | a stomach acid suppressan |
|
| human fecal material; processed, frozen administered orally | Biological | human fecal material; processed, frozen, administered orally |
|
| human fecal material; processed, frozen; administered orally and rectally | Biological | human fecal material; processed, frozen; administered orally and rectally |
|
| Blood Safety Markers (Assessment of Blood Chemistry Panel and Complete Blood Count) | Number of participants who had a clinically significant change in their blood safety markers (comprehensive metabolic panel including kidney/liver function and complete blood count with differential) | Baseline and 10 weeks (end of treatment) |
| Childhood Autism Rating Scale (CARS) | The CARS is an assessment of 15 autism-related symptoms. Each item is scored on a scale of 1 (no symptoms) to 4 (severe symptoms), and the scores for each symptom are summed to obtain a total score. So, the possible scores range from 15 to 60, with a higher score indicating greater severity. | Baseline and 10 weeks (end of treatment) |
| Social Responsiveness Scale (SRS) | The SRS is an assessment of social skills based on 65 items, where each item is scored on a range of 0 (no symptoms) to 3 (severe symptoms). The total score is a sum of the individual scores, so the total possible range is from 0 to 195, with a higher score indicating greater severity of symptoms. | Baseline and 10 weeks (end of treatment) |
| Short Sensory Profile | The Short Sensory Profile is an assessment of sensory problems. However, the data on this scale was not collected due to administrative error. | baseline and 10 weeks |
| Vineland Adaptive Behavior Scale (VABS) | The VABS is an assessment of adaptive behaviors, and we analyzed it to determine the developmental age of the participants, with possible scores ranging from 0 years to 21 years. | baseline and 18 weeks (8 weeks after treatment stopped) |
| Daily Stool Record (DSR) | The DSR is a record of the type of stool that a participant had each day, using the Bristol Stool Form which ranges from 1 (very hard) to 7 (liquid). We then analyzed the data as % days of abnormal stools over a 14 day period, where an abnormal stool is defined as an unusually hard stool (types 1-2), unusually soft stool (types 6-7), or no stool that day. So, the possible range of % days of abnormal stools is from 0% to 100%, with a higher score indicating a more severe problem. | Baseline and 10 weeks (end of treatment) |
| 28122648 | Result | Kang DW, Adams JB, Gregory AC, Borody T, Chittick L, Fasano A, Khoruts A, Geis E, Maldonado J, McDonough-Means S, Pollard EL, Roux S, Sadowsky MJ, Lipson KS, Sullivan MB, Caporaso JG, Krajmalnik-Brown R. Microbiota Transfer Therapy alters gut ecosystem and improves gastrointestinal and autism symptoms: an open-label study. Microbiome. 2017 Jan 23;5(1):10. doi: 10.1186/s40168-016-0225-7. |
| BG001 | Rectal Group | This group will receive some treatments rectally and some orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen. oral Vancomycin: an antibiotic MoviPrep: a bowel cleanse Prilosec: a stomach acid suppressan human fecal material; processed, frozen; administered orally and rectally: human fecal material; processed, frozen; administered orally and rectally |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Parent Global Impressions-Revised (PGI-R) | The PGI-R is a rating of change of 18 autism symptoms compared to baseline, with each symptom rated on a Likert scale from -3 (much worse) to zero (no change) to +3 (much better). We report the average change of the 18 symptoms, so the possible range is from -3 to +3. | We report the data on all participants regardless of how the initial dose of bacteria was administered. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 10 weeks (end of treatment) |
|
|
|
|
| Secondary | Blood Safety Markers (Assessment of Blood Chemistry Panel and Complete Blood Count) | Number of participants who had a clinically significant change in their blood safety markers (comprehensive metabolic panel including kidney/liver function and complete blood count with differential) | We report the data on 18 participants, regardless of how the initial dose of bacteria was administered. | Posted | Number | participants | Baseline and 10 weeks (end of treatment) |
|
|
|
| Secondary | Childhood Autism Rating Scale (CARS) | The CARS is an assessment of 15 autism-related symptoms. Each item is scored on a scale of 1 (no symptoms) to 4 (severe symptoms), and the scores for each symptom are summed to obtain a total score. So, the possible scores range from 15 to 60, with a higher score indicating greater severity. | We report the data on all participants, regardless of how the initial dose of bacteria was administered. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 10 weeks (end of treatment) |
|
|
|
|
| Secondary | Social Responsiveness Scale (SRS) | The SRS is an assessment of social skills based on 65 items, where each item is scored on a range of 0 (no symptoms) to 3 (severe symptoms). The total score is a sum of the individual scores, so the total possible range is from 0 to 195, with a higher score indicating greater severity of symptoms. | We report the data on 18 participants, regardless of how the initial dose of bacteria was administered. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 10 weeks (end of treatment) |
|
|
|
|
| Secondary | Short Sensory Profile | The Short Sensory Profile is an assessment of sensory problems. However, the data on this scale was not collected due to administrative error. | Due to a logistical error, this data was not collected | Posted | baseline and 10 weeks |
|
|
| Secondary | Vineland Adaptive Behavior Scale (VABS) | The VABS is an assessment of adaptive behaviors, and we analyzed it to determine the developmental age of the participants, with possible scores ranging from 0 years to 21 years. | We report the data on all participants, regardless of how they received the initial dose of bacteria. | Posted | Mean | Standard Deviation | years | baseline and 18 weeks (8 weeks after treatment stopped) |
|
|
|
|
| Secondary | Daily Stool Record (DSR) | The DSR is a record of the type of stool that a participant had each day, using the Bristol Stool Form which ranges from 1 (very hard) to 7 (liquid). We then analyzed the data as % days of abnormal stools over a 14 day period, where an abnormal stool is defined as an unusually hard stool (types 1-2), unusually soft stool (types 6-7), or no stool that day. So, the possible range of % days of abnormal stools is from 0% to 100%, with a higher score indicating a more severe problem. | We report the data on all participants, regardless of how the initial dose of bacteria was administered. | Posted | Mean | Standard Deviation | percentage of days with abnormal stool | Baseline and 10 weeks (end of treatment) |
|
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 12 |
| 18 |
|
| nausea/vomiting | Gastrointestinal disorders | Non-systematic Assessment | 1 participant experienced nausea and vomiting with the first of the high-dose microbiota. She was switched to the rectal group, which was tolerated without adverse effect |
|
| hyperactivity and/or irritability | Nervous system disorders | Non-systematic Assessment | Within 1-4 days after the start of the vancomycin, 12 children with ASD had a temporary hyperactivity (7 cases) or tantrums/aggression (5 cases). The symptoms lasted 1-3 days in most cases, but one participant had symptoms lasting for 3 weeks. |
|
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D046529 | Microscopy, Electron, Transmission |
| D008854 | Microscopy, Electron |
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D044367 | Phase Transition |
| D055585 | Physical Phenomena |
| D003080 | Cold Temperature |
| D013696 | Temperature |
| D013816 | Thermodynamics |
| D055598 | Chemical Phenomena |