← Back to Search

Microbiota Therapy

Group A: Treatment for Pitt Hopkins Syndrome

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).

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (for 14 days pre-treatment) vs end of treatment (days 82-95 of treatment).

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Daily Stool Record (DSR)

Safety Measures (Adverse Events)

Secondary outcome measures

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

2005

Completed Phase 4

~7930

Magnesium Citrate

2016

N/A

~160

Antacid

2021

Completed Phase 1

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Pitt Hopkins Research FoundationUNKNOWN

2 Previous Clinical Trials

20,007 Total Patients Enrolled

2 Trials studying Pitt Hopkins Syndrome

20,007 Patients Enrolled for Pitt Hopkins Syndrome

Gut-Brain-Axis Therapeutics Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the risks associated with Group A treatment for patients?

"Based on our team's assessment at Power, the safety rating for Group A: Treatment is 2. This score reflects the available data supporting safety in this Phase 2 trial but does not indicate any evidence regarding efficacy."

Answered by AI

What is the primary goal of conducting this clinical trial?

"The main objective of this research is to assess Safety Measures by comparing Adverse Events from Baseline (during the 14 days before treatment) to End of Treatment (between Days 82-95 of therapy). Secondary endpoints include evaluating Gastrointestinal symptoms using the Clinical Global Impression - Gastrointestinal scale, which rates symptom severity on a scale ranging from normal or not at all ill (1) to extremely severe illness (7). Additionally, assessing Pitt Hopkins Symptoms with the Clinical Global Impression - Pitt Hopkins scale that also uses a 7-point severity rating. Lastly, utilizing the Gastrointestinal Symptom Rating Scale involving 15 questions"

Answered by AI

What is the current number of individuals who have been granted admission to participate in this clinical study?

"Affirmative, data available on clinicaltrials.gov confirms the ongoing patient recruitment for this medical investigation. The trial was initially posted on February 27th, 2024, with the most recent update made on March 14th, 2024. To complete the study successfully, researchers aim to enlist a total of 20 participants from one designated site."

Answered by AI

Is the process of enrolling participants still ongoing for this medical study?

"Indeed, the details on clinicaltrials.gov show that this trial is currently seeking participants. Initially listed on February 27th, 2024 and most recently revised on March 14th, 2024, they aim to enroll a total of 20 patients at one designated site."

Answered by AI

Is the inclusion criteria for this research study limited to individuals who are above 35 years old?

"To be eligible for participation, subjects must be between 5 and 55 years of age as per the study's inclusion criteria."

Answered by AI

Am I eligible to enroll in this medical research study?

"To be eligible for participation, individuals must have a diagnosis of Pitt Hopkins syndrome and fall within the age range of 5 to 55 years. A maximum of 20 participants will be accepted into this research endeavor."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Microbiota Transfer Therapy for Children and Adults With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders

2024. "Microbiota Transfer Therapy for Children and Adults With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06321796.

All > Phoenix > Paid Studies Glendale