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Laxative

vancomycin, magnesium citrate, microbiota for Pitt Hopkins Syndrome

Phase 2
Waitlist Available
Research Sponsored by Arizona State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in % abnormal days from baseline (for 2 weeks) vs. week 14 (2 weeks from week 13-14)

Summary

This trial is testing a treatment called Microbiota Transfer Therapy (MTT) for children aged 5-17 with Pitt Hopkins Syndrome and gut issues. The treatment involves using an antibiotic to kill bad bacteria, cleaning out the bowels, and adding healthy bacteria from donor stool. The goal is to see if this helps improve their gut health.

Eligible Conditions
  • Pitt Hopkins Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in % abnormal days from baseline (for 2 weeks) vs. week 14 (2 weeks from week 13-14)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in % abnormal days from baseline (for 2 weeks) vs. week 14 (2 weeks from week 13-14) 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
Secondary study objectives
CGI for GI Disorders
CGI for PTHS Symptoms
FLACC
+2 more

Side effects data

From 2022 Phase 2 trial • 6 Patients • NCT04132427
67%
Diarrhea
67%
Gassy
67%
Change in Stool Color
33%
Abdominal Pain
33%
Hyperactivity
33%
Irritability
33%
Constipation
33%
Redness- Genitalia
33%
Loss of appetite
33%
Insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group A: Treatment
Group B: Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group A: TreatmentExperimental Treatment1 Intervention
Vancomycin, magnesium citrate, microbiota
Group II: Group B: PlaceboPlacebo Group1 Intervention
placebo vancomycin, real magnesium citrate (because it obviously empties the bowels) and placebo microbiota
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
vancomycin, magnesium citrate, microbiota
2019
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

Pitt Hopkins Research FoundationUNKNOWN
2 Previous Clinical Trials
20,020 Total Patients Enrolled
2 Trials studying Pitt Hopkins Syndrome
20,020 Patients Enrolled for Pitt Hopkins Syndrome
Arizona State UniversityLead Sponsor
298 Previous Clinical Trials
107,931 Total Patients Enrolled
~1 spots leftby Nov 2025
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