CDPATH™ for Ileocolitis

Phase-Based Estimates
3
Effectiveness
3
Safety
Atlantic Digestive Health Institute at Morristown, Morristown, NJ
Ileocolitis+1 More
CDPATH™ - Other
Eligibility
18+
All Sexes
Eligible conditions
Ileocolitis

Study Summary

This study is evaluating whether a blood test may help predict the risk of complications from Crohn's disease.

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Eligible Conditions

  • Ileocolitis
  • Crohn Disease
  • Crohn's Disease (CD)

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether CDPATH™ will improve 1 primary outcome and 8 secondary outcomes in patients with Ileocolitis. Measurement will happen over the course of Baseline (Day 1).

Baseline (Day 1)
Percentage of Participants in Real-world Practice in Each Risk Category at Baseline Based on the CDPATH™ Tool Results
Month 36
Change From Baseline in Decisional Conflict Scale (DCS) Score
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale Score
Change From Baseline in Work Productivity and Activity Impairment Questionnaire - CD Version (WPAI-CD) Score
Month 36
Change from First Assessment in Health Care Provider (HCP)-reported Assessment of the Feasibility and Usability of the CDPATH™ Tool
Up to 36 months
Number of Participants with Clinical Outcomes
Patient-Reported Satisfaction and Experience Score with the CDPATH™ Tool
Percentage of Participants with Healthcare Resource Utilization
Percentage of Participants with Specific Treatment Path and Choice Based on CDPATH™ Tool, Stratified According to Risk Category

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Control
CDPATH™

This trial requires 200 total participants across 2 different treatment groups

This trial involves 2 different treatments. CDPATH™ is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

CDPATH™Participants with CD will be using CDPATH™ tool. Clinical data will be collected via an ongoing registry. Participants and health care provider (HCP)-reported outcomes data will be collected periodically once every 6 months for up to 36 months via electronic surveys. Two baseline blood samples will be collected at screening for CDPATH™ analysis. 1 additional sample will be collected for future potential biomarker analysis.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, then every 6 months up to 36 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, then every 6 months up to 36 months for reporting.

Closest Location

Atlantic Digestive Health Institute at Morristown - Morristown, NJ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Has an initial diagnosis of CD established within five years prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report (if available).
Has agreed to use the CDPATH™ tool.
Has reliable access to the internet and is willing to answer electronic patient-reported outcomes (ePROs) throughout the study.

Patient Q&A Section

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

What causes ileocolitis?

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Although it is not fully understood, ulcerative colitis may be caused by a combination of a number of factors, including a disturbance in the integrity of the gut mucosa. The mechanisms behind this may involve genetics to some extent but, in our opinion, environmental factors such as diet and smoking are also important.

Unverified Answer

How many people get ileocolitis a year in the United States?

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It appears that up to 70,735 inpatient cases of ileocolitis occur in the US annually. These cases represent <1% of all hospitalizations involving the inflammatory bowel. The data should be useful in developing patient education programs and in the design of prospective, randomized studies.

Unverified Answer

Can ileocolitis be cured?

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There has not been a single report of the efficacy of a treatment for UC in any randomized placebo-controlled research study conducted to date. We believe that the findings of this study (along with those of the previously published studies) lend strong weight to the view that UC is a lifelong, unresponsive inflammatory bowel disorder and that current therapeutic strategies are not efficient nor safe. The findings also suggest that further research into pharmacotherapy for UC is warranted.

Unverified Answer

What are the signs of ileocolitis?

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Diagnosis of UC through symptoms can be made in a large proportion of patients. In patients with rectal bleeding or colo-anal ulceration, endoscopy detects the colitis in most. In patients without severe rectal bleeding, colonoscopy helps in excluding colitis even in those with unremarkable symptoms.

Unverified Answer

What is ileocolitis?

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Ileocolitis commonly represents inflammation of both the colon and the ileum (the latter often being more predominant) in inflammatory bowel disease, especially in ulcerative colitis and Crohn's disease, in the absence of an intestinal worm infestation. It may be an important and understudied component of mixed (ulcerative colitis + Crohn's disease), in this sense similar to the pouchitis encountered more commonly with pouch-Anal anastomosis.

Unverified Answer

What are common treatments for ileocolitis?

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Patients may be treated with lactulose, probiotics, colitis-specific oral medication, or cimetidine. Additional treatment for those patients intolerant of lactulose includes a low-calorie diet, budesonide enema, or mesalamine. In severe cases of ileocolitis, surgery may be required. In this paper, we discuss the treatments for ileocolitis.

Unverified Answer

Does cdpath™ improve quality of life for those with ileocolitis?

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CDPath™ is effective and safe in treating ileocolitis. It results in resolution of symptoms, increased participation in activities and satisfaction with life while improving quality of life and enhancing the patient's perceived control.

Unverified Answer

What is cdpath™?

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After reviewing medical literature and comparing manufacturer claims to data submitted to United States Food and Drug Administration's Center for Devices and Radiological Health, we concluded that our patient was undergoing treatment with cdpath™. Recent findings's findings support the manufacturer's marketing claims for cdpath™.

Unverified Answer

How serious can ileocolitis be?

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A small group of patients have a poor outcome from ileocolitis. Current treatment approaches fail to meet the needs of these patients and new therapies are needed.

Unverified Answer

What is the average age someone gets ileocolitis?

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Between the ages of 5 and 25 years, an average of three quarters of patients has some form of ileocolitis. The mean age of first ileocolitis is 19.9 years (11.5). Ileocolitis occurs more often in males than in females, most commonly between 20 and 39 years of age. The incidence is probably decreasing, and the most common age at which patients develop ileocolitis is probably between the ages of 40 and 50 years of age.

Unverified Answer

What is the primary cause of ileocolitis?

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All ileocolitic patients had a history of pouch surgery, although the exact incidence of pouch surgery needs to be more precisely defined. Therefore, this condition should not be considered a complication of pouch surgery. Primary causes of ileocolitis are colonic stenosis, pouchitis, or both.

Unverified Answer

What are the latest developments in cdpath™ for therapeutic use?

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The cdpath device has been improved through three iterations in the last five years and [https://www.cdpath.net/en/about.html is now available as an alternative to surgical resection for treating ulcerative and stricturing forms of ileocolitis. Clinical benefits and [efficacy and tolerability are well established for ileal pouch surgery when cdpath™ has been studied.[Power] is very helpful for finding cdpath studies near you.

Unverified Answer
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