Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503978
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Microbiota Transplant Therapy for Children With Both Autism Spectrum Disorder and Gastrointestinal Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Dosing Study of Microbiota Transplant Therapy for Children With Autism Spectrum Disorder ASD Who Have Gastrointestinal Disorders
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators propose to investigate Microbiota Transfer Therapy MTT for treating patients with Autism-spectrum disorder with Gastrointestinal disorders constipation diarrhea andor 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 andor 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 bacteriafeces 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
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 bacteriafeces 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None