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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)
Awards & highlights

Study Summary

This trial will study if Microbiota Transfer Therapy (MTT) is effective in treating patients with Pitt Hopkins Syndrome (PTHS) and gastrointestinal problems similar to Irritable Bowel Syndrome (IBS).

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Daily Stool Record (DSR(
Safety Measures
Secondary outcome measures
CGI for GI Disorders
CGI for PTHS Symptoms
FLACC
+2 more

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
283 Previous Clinical Trials
109,507 Total Patients Enrolled

Frequently Asked Questions

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

Have any of the drugs vancomycin, magnesium citrate and microbiota obtained regulatory endorsement?

"Vancomycin, magnesium citrate, and microbiota have all been studied for safety in Phase 2 trials. As such, Power rated them as having a level of security that is satisfactory but not yet fully established with the necessary evidence to ensure efficacy."

Answered by AI

Are any additional participants needed for this scientific investigation?

"According to the information present on clinicaltrials.gov, this trial is no longer searching for candidates; last edited in December 2021 and first posted in September 2019. Despite this, there are over 1500 other active trials that participants can join at any given time."

Answered by AI

What is the current participant count in this clinical investigation?

"This clinical trial has ceased recruitment, having been posted on September 30th 2019 and last updated December 29th 2021. Still, 1496 trials are in the process of enrolling patients with cholera infantum while 57 studies are looking for participants to investigate vancomycin, magnesium citrate, and microbiota."

Answered by AI

To what end is vancomycin, magnesium citrate, and microbiota typically employed?

"Vancomycin, magnesium citrate and microbiota can be effective treatments for clostridium difficile associated diarrhea (cdad), staphylococcal infections, as well as prophylaxis of migraine headaches."

Answered by AI

Who is eligible to partake in this clinical trial?

"This trial seeks 7 candidates, aged between seven and seventeen, with a confirmed diagnosis of cholera infantum. It is also necessary for applicants to have been afflicted by GI issues for no less than two years without any change in treatments or diet over the past two months. Furthermore, they must be physically able to swallow pills unchewed as well as provide access to records from their last 24-month medical history for review by the study's physician"

Answered by AI

Are people aged 30 and over eligible to join this experiment?

"The age limitations for this trial are 7 years old at the youngest and 17 years old at the oldest."

Answered by AI

What are the core aims of this research endeavor?

"The main objective of this clinical trial, measured over a two-week period from baseline to week 14, is to analyse safety markers. Secondary objectives include Parent Global Impressions of Pitt Hopkins Syndrome symptoms (PGI-PTHS), rated on a scale from -3 (much worse) to +3 (much better); Clinical Global Impressions of GI Disorders severity rating on a 1-7 scale with 1 being normal and 7 being the worst; and Clinical Global Impressions of PTHS Symptoms severity ratings also ranging between 1 and 7."

Answered by AI

Have prior experiments been conducted to evaluate the efficacy of vancomycin, magnesium citrate and microbiota?

"Currently, there are 57 active clinical trials for vancomycin, magnesium citrate and microbiota with 7 of these being in Phase 3. Seven of the observed studies take place in Jupiter, Florida whilst all 342 research sites across the nation explore potential uses for this medication."

Answered by AI
~1 spots leftby Apr 2025