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Clinical Trails at Rush A Longitudinal Study: Dysbiosis and IBD
Clinical Trial Protocol ID
04092807

Clinical Trial Investigator Name
Ece Mutlu, MD

Clinical Trial Title

Dysbiosis and IBD: A Longitudinal Study



Clinical Trial Protocol Description

The cause of Inflammatory Bowel Disease (IBD) is not yet known.  It has been speculated that variation in the bacterial composition of the colon may play a key role in the development of disease.  Patients in this study will undergo a colonoscopy (as clinically indicated) or flexible sigmoidoscopy during which time tiny tissue samples called biopsies will be collected.  These samples will be sent to a laboratory where bacteria will be isolated and identified.  Comparisons will then be made to evaluate any differences between the bacteria found in healthy persons versus persons with disease.  Participants will also fill out several symptom and diet history questionnaires and receive study related blood work at no charge.  This study requires four visits over the period of one year.  Patients are reimbursed up to $150 depending upon completion of the study.  



Clinical Trial Eligibility Criteria

The study is recruiting four groups: Active Disease, New Disease, Remission and Healthy Controls. To participate in this study, all participants must:

  • Be a non-smoker or have no change in smoking habits in the past month
  • Be born and raised in the US
  • Have a consistent, healthy weight with stable dietary habits over the last year

Additionally, the following criterion applies for each group:

For the Active Disease group, patients must:

  • Have documented Ulcerative Colitis or Crohn’s Disease
  • Have chronic active Inflammatory Bowel Disease (IBD) for at least 2 weeks

For the New Disease Group, patients must:

  • Have symptoms of intermittent recurrent bloody diarrhea, abdominal pain or weight loss

For the Remission Group, patients must:

  • Have documented ulcerative colitis or ileocolonic or colonic Crohn’s Disease
  • Be in remission for the six months preceding the study
  • Inactive IBD for at least 2 weeks as determined by clinical indices

For the Healthy Controls Group, patients must:

  • Be undergoing a routine colon cancer screening or being evaluated for rectal bleeding

For more information, or to participate in the trial, please call the contact individual listed below.





Contact Name GI Clinical Trials
Contact Phone (312) 942-3466
Contact E-mail clinical_trials@rush.edu
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A Longitudinal Study: Dysbiosis and IBD

   
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