The Assessment of Infrared Treatment for Crohn's Disease

Launched by ELI SPRECHER, MD · Nov 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of far infrared (fIR) therapy as a potential treatment for Crohn's disease, which is a type of inflammatory bowel disease (IBD). The main goals are to find out if fIR therapy is safe and if it can effectively help reduce symptoms in patients with Crohn's disease. Participants in the trial will receive 10 sessions of either high-intensity fIR therapy or a lower-intensity version (which is like a placebo). They will also provide stool and blood samples and answer some questions about their health and symptoms.

To be eligible for the study, participants should be between 18 and 80 years old, have a confirmed diagnosis of Crohn's disease, and have a certain level of disease activity as measured by a specific score. It’s important that they are not on any changing medications for their Crohn's during the trial. Participants can expect to be closely monitored throughout the study, providing valuable information that can help researchers understand the potential benefits of fIR therapy for Crohn's disease. If you're considering joining, it’s a good idea to discuss it with your healthcare provider to see if it's right for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. An established Crohn's disease
• • 2. 18 \< age \< 80
• • 3. No therapy or on constant medicinal regimen throughout the study period: mesalamine at least 6 weeks, or steroids at least 2 weeks, or immunomodulatory drugs at least 12 weeks or biologics at least 12 weeks, medical cannabis at least 2 weeks before the study.
• • 4. CD patients will be included if their symptoms score \>4 on the Harvey-Bradshaw index (HBI) score and/or fecal calprotectin level \> 150 ug/gr.
• Exclusion Criteria:
• • 1. BMI greater than 30 Kg/m2
• • 2. Any proven current infection such as Clostridioides difficile infection, positive stool culture, or parasites.
• • 3. Inability to sign informed consent and complete study protocol
• • 4. Pregnancy
• • 5. Subjects with chronic conditions such as cancer, organ transplant subjects, advanced kidney or liver disease, systemic inflammatory conditions other than IBD.
• • 6. Presence of abscess and cysts in the liver/ kidneys or pancreas
• • 7. Evidence of an abdominal abscess or entero-enteric fistula.
• • 8. More than one CD luminal surgery or a small bowel length \< 1.5 meter