CDI provides reference laboratory, diagnostic solutions, and trial coordination as well as patient recruitment and enrollment services for sponsors, CROs, and principal investigators in IRB & FDA Phases I, II, and III.

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Testing & Technology

  • Analytical methods and protocols to accommodate both small and large-scale studies while maintaining regulatory requirements
  • Experienced GC, biochemical, and analytical scientists on staff to fulfill critical requests of sponsors and CROs
  • Extensive management and coordination experience in an FDA clinical trial atmosphere
  • Vast portfolio of diagnostic solutions including hydrogen and methane breath tests and proprietary capillary blood test kits for GI biomarkers
  • Data delivery in highly accurate, traceable, and timely manner
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Recruitment & Enrollment

  • Accelerated recruitment efforts with cost-effective targeting via social media, email, and other digital marketing channels
  • Leverages proprietary algorithms and analytics tools to build “Custom Audiences” to pinpoint well-characterized and highly motivated clinical trial candidates
  • Powered by MyGIHealth patient population of 70M+ sufferers of GI disorders in the U.S.
  • Significantly reduces direct-to-consumer and other inefficient, expensive marketing costs related to trial enrollment and unbranded campaigns
  • Customized patient portals and digital scheduling tools simplify the patient and trial coordination experience

As a CLIA-certified laboratory for high complexity testing that also holds all necessary state licensure to participate in clinical trials involving human blood and breath specimens, and as a FDA-Registered, ISO-13485-certified medical device manufacturer providing diagnostic solutions throughout the United States, Canada (MDEL), the United Kingdom, and Europe, CDI’s CE marked at-home test kits provide the optimal strategy for obtaining diagnostic data for clinical studies and trials in a post-COVID environment. All CDI staff is HIPPA-compliant trained and experienced with handling protected health information and other sensitive data.

We pride ourselves on precise and accurate results with the highest level of data integrity.

Representation of CDI’s Breath Test Clinical Trials Experience:

Salix Pharmaceuticals (2012-2014)

Breath testing for SIBO was performed during a Phase III double-blind FDA clinical trial. Subjects were enrolled to evaluate the efficacy of Rifaximin (Xifaxan), the antibiotic of interest in the clinical trial. Subjects were to take a series of four breath test to analyze the successful course of Rifaximin (Xifaxan) by having the breath tests performed every two weeks in a “on antibiotic” and “off antibiotic” alternating course of treatment that spanned eight weeks.

Synthetic Biologics (2015 – 2016)

Breath testing for SIBO was performed during a Phase II FDA double-blind clinical trial. Subjects were first screened by breath testing for methane-producing bacteria to be assigned to certain study arms. The drug of interest was a statin-based drug that was theorized to block the production of methane gas in subjects’ GI tract. Multiple breath tests were performed throughout the trial to evaluate the ability of the drug to decrease methane gas production.

QOL Medical, LLC (2014-2017)

Diagnostic breath testing for Sucrose Malabsorption/Intolerance was performed to decide who to enroll as subjects to evaluate the efficacy of the enzyme replacement drug, Sucraid. Breath testing was used to help diagnose the subjects with Congenital sucrase-isomaltase deficiency in order to enroll them into the trial to study the drug.

Northwestern University (2019 – Present)

Two separate studies are currently being conducted by Northwestern researchers. 1) Breath Testing for SIBO is being performed to evaluate the correlation(s) between GERD and SIBO to determine if diet and/or portion control during meals can influence the symptom severity of either GERD, SIBO, or both. 2) Breath testing for SIBO and IMO is being performed to evaluate the efficacy of a new nutraceutical developed to relieve bloating and abdominal discomfort caused by gas in the gut, Antrantil.

Functional Gut Diagnostics, Ltd.

In addition to CDI’s CLIA-certified laboratory in Salem, MA, CDI also participates in various transatlantic and European clinical studies and trials via its joint venture partner and sister laboratory Functional Gut Diagnostics, Ltd., a fully accredited laboratory located in London and Manchester, UK. All European studies are conducted under the direction of Dr. Anthony Hobson, Clinical Director and Senior Clinical GI Scientist.

University of Michigan (2019 – Present)

Prospective sponsored trial to determine whether hydrogen and methane breath testing can be used to identify patients with IBS-D (Irritable Bowel Syndrome with diarrhea predominance) who are more likely to respond to antibiotic therapy (Rifaximin).

CDI’s Blood-Based Clinical Trial Experience:

In addition to our laboratory’s vast breath testing clinical trial experience, CDI’s laboratory is also currently involved in multiple sponsor-lead and investigator-lead clinical studies and trials involving blood-based biomarkers for Irritable Bowel Syndrome (IBS), Celiac Disease, Non-Celiac Gluten Sensitivity, Inflammatory Bowel Disease, and related conditions and disorders. Many of these studies incorporate CDI’s at-home IBSchek® Capillary Collection Kit for IBS with diarrhea and mixed symptoms (IBS-D/M), the first clinically validated blood test for IBS that looks for specific biomarkers (anti-CdtB and anti-vinculin) that result from post-infectious gastroenteritis (food poisoning).

CDI can work with clinical teams to customize test options and panels that meet each trial’s specific needs.