Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321796
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-07
Brief Title:
Microbiota Transfer Therapy for Children and Adults With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders
Sponsor:
Gut-Brain-Axis Therapeutics Inc
Organization:
Gut-Brain-Axis Therapeutics Inc
Study Overview
Official Title:
Microbiota Transfer Therapy for Children and Adults With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders MTP-101 P
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 Pitt-Hopkins Syndrome PTHS and gastrointestinal problems constipation bloating abdominal pain MTT involves a combination of 10 days of oral vancomycin an antibiotic to kill pathogenic bacteria followed by 1 day of bowel cleanse using magnesium citrate followed by 4 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 5-17 years old and adults 18-55 years old with Pitt-Hopkins Syndrome PTHS and Gastrointestinal GI problems who have attempted two standard-of-care SOC GI treatments with no alleviation of symptoms This is a Phase 2 clinical trial that will evaluate the safety tolerability and efficacy of a powder version of Microbiota Transfer Therapy MTT called MTP-101P The three parts of this trial are described below
Part 1 Placebo-Controlled Treatment 14 Weeks The trial will begin with a randomized double-blind placebo-controlled trial which will include a 10-day treatment with oral vancomycin or placebo then 1 day of magnesium citrate to cleanse the bowel of vancomycin and bacteriafeces all participants since its bowel-emptying effect cannot be blinded followed by 4 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 vs Group B Placebo vancomycin real magnesium citrate placebo MTP-101P real antacid
Part 2 Open-Label Observation and Cross-Over 14 weeks Group A Observation over the next 14 weeks no additional treatment Group A completes the study at the end of part 2
Group B They will receive the same treatment that Group A received in part 1 This includes 10 days of vancomycin magnesium citrate and an initial high dose of MTP-101P for 4 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 B There will be a follow-up evaluation 14 weeks post-treatment after the end of Part 2 to assess long-term efficacy and possible adverse effects
Part 1 Placebo-Controlled Treatment 14 Weeks The trial will begin with a randomized double-blind placebo-controlled trial which will include a 10-day treatment with oral vancomycin or placebo then 1 day of magnesium citrate to cleanse the bowel of vancomycin and bacteriafeces all participants since its bowel-emptying effect cannot be blinded followed by 4 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 vs Group B Placebo vancomycin real magnesium citrate placebo MTP-101P real antacid
Part 2 Open-Label Observation and Cross-Over 14 weeks Group A Observation over the next 14 weeks no additional treatment Group A completes the study at the end of part 2
Group B They will receive the same treatment that Group A received in part 1 This includes 10 days of vancomycin magnesium citrate and an initial high dose of MTP-101P for 4 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 B There will be a follow-up evaluation 14 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?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None