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IBD for Irritable Bowel Syndrome

N/A
Waitlist Available
Led By David A Johnson, MD
Research Sponsored by HyGIeaCare, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial will compare the microbes and peptides in inner-colonic samples from IBD patients to those from home stool samples.

Eligible Conditions
  • Irritable Bowel Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Detection of IBD-related microbiome-derived biomarkers in stool samples
cox wilcoxon test
unpaired T-test
Secondary outcome measures
Alpha diversity
Differential abundance analysis
Shannon index
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IBDExperimental Treatment1 Intervention
10 patients diagnosed with colonic IBD (5 diagnosed with Ulcerative Colitis and 5 diagnosed with Crohn's Disease) scheduled for a surveillance colonoscopy
Group II: ControlActive Control1 Intervention
10 patients scheduled for a routine screening colonoscopy who do not have a history of IBD symptoms or IBD diagnosis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hygieacare System
2022
N/A
~20

Find a Location

Who is running the clinical trial?

HyGIeaCare, Inc.Lead Sponsor
6 Previous Clinical Trials
54 Total Patients Enrolled
David A Johnson, MDPrincipal InvestigatorDigestive & Liver Disease Specialists
4 Previous Clinical Trials
104 Total Patients Enrolled

Frequently Asked Questions

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

Are there still opportunities for subjects to participate in this clinical trial?

"This research trial, which was first available for enrolment on March 16th 2022, is still looking to add new participants according to the information posted on clinicaltrials.gov and last updated on November 28th of this year."

Answered by AI

Does the protocol for this trial allow individuals of advanced age to participate?

"To be eligible for this clinical trial, applicants must range between the ages of 18 to 80. Alternatively, there are 69 similar trials available for minors and 229 such studies for elderly individuals."

Answered by AI

What is the upper limit of participants in this clinical trial?

"Yes, the details on clinicaltrials.gov confirm that this trial is still recruiting participants. This clinical study was initially published on March 16th 2022 and updated most recently on November 28th 2022. The research team seeks 20 willing volunteers from a single location."

Answered by AI

What are the goals of this investigation?

"The primary outcome reported by the study sponsor, HyGIeaCare Inc., will be monitored over a course of 1 year and pertains to detecting IBD-related biomarkers in stool samples. Secondary outcomes include differential abundance analysis with false discovery rate correction, alpha diversity through 16S and meta genomics analysis, as well as beta diversity using PCoA evaluation."

Answered by AI

What kind of individuals are best suited for this clinical trial?

"This clinical trial is recruiting 20 individuals, aged 18-80 years old, who suffer from irritable bowel syndrome (IBS). Additional requirements include a diagnosis of either Ulcerative colitis or Crohn's disease for the study arm and no active IBD symptoms/diagnosis for those in the control arm."

Answered by AI
~7 spots leftby Mar 2025