← Back to Search

Microbiota Therapy

Microbiota Transfer Therapy for Pitt-Hopkins Syndrome and Gastrointestinal Disorders

Phase 2
Recruiting
Research Sponsored by Gut-Brain-Axis Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (for 14 days pre-treatment) vs end of treatment (days 82-95 of treatment).

Summary

This trial aims to study a treatment called Microbiota Transfer Therapy (MTT) for individuals with Pitt-Hopkins Syndrome (PTHS) and gastrointestinal issues like constipation and abdominal pain. M

Who is the study for?
This trial is for children and adults with Pitt Hopkins Syndrome, which includes intellectual disability and gastrointestinal issues like constipation. Participants should also have a history of hyperventilation or abnormal facial expressions related to the syndrome.
What is being tested?
The study tests Microbiota Transfer Therapy (MTT), involving an antibiotic called vancomycin, a bowel cleanse with magnesium citrate, followed by high then lower doses of MTP-101P with an antacid over several weeks against placebo treatments.
What are the potential side effects?
Possible side effects may include digestive upset from vancomycin or magnesium citrate, such as diarrhea or nausea. The transfer therapy might cause bloating, abdominal discomfort, or changes in bowel habits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (for 14 days pre-treatment) vs end of treatment (days 82-95 of treatment).
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (for 14 days pre-treatment) vs end of treatment (days 82-95 of treatment). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Daily Stool Record (DSR)
Safety Measures (Adverse Events)
Secondary study objectives
Clinical Global Impression - Gastrointestinal (CGI-GI)
Clinical Global Impression - Pitt Hopkins (CGI-PTHS)
Gastrointestinal Symptom Rating Scale (GSRS)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group A: TreatmentExperimental Treatment4 Interventions
Part 1: Blinded Treatment (14 weeks) Vancomycin, Magnesium Citrate, Antacid, MTP-101P
Group II: Group B: PlaceboPlacebo Group4 Interventions
Part 1: Blinded Placebo (14 weeks) Placebo Vancomycin, Real Magnesium Citrate, Real Antacid, Placebo MTP-101P
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vancomycin
2020
Completed Phase 4
~7920
Magnesium Citrate
2016
N/A
~160
Antacid
2021
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Pitt Hopkins Research FoundationUNKNOWN
2 Previous Clinical Trials
20,006 Total Patients Enrolled
2 Trials studying Pitt Hopkins Syndrome
20,006 Patients Enrolled for Pitt Hopkins Syndrome
Gut-Brain-Axis Therapeutics Inc.Lead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
~4 spots leftby Feb 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top