Status:
RECRUITING
The Assessment of Infrared Treatment for Crohn's Disease
Lead Sponsor:
Eli Sprecher, MD
Conditions:
IBD
Inflammatory Bowel Diseases
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to test the safety and efficacy of far Infra-red (fIR) therapy in Crohn's disease patients. The main questions it aims to answer are: 1. Is infrared therapy safe f...
Detailed Description
Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic relapsing diseases that carry considerable impact on patients' quality of life, including obj...
Eligibility Criteria
Inclusion
- An established Crohn's disease
- 18 \< age \< 80
- 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.
- 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
- BMI greater than 30 Kg/m2
- Any proven current infection such as Clostridioides difficile infection, positive stool culture, or parasites.
- Inability to sign informed consent and complete study protocol
- Pregnancy
- Subjects with chronic conditions such as cancer, organ transplant subjects, advanced kidney or liver disease, systemic inflammatory conditions other than IBD.
- Presence of abscess and cysts in the liver/ kidneys or pancreas
- Evidence of an abdominal abscess or entero-enteric fistula.
- More than one CD luminal surgery or a small bowel length \< 1.5 meter
Key Trial Info
Start Date :
September 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06146816
Start Date
September 12 2023
End Date
April 1 2026
Last Update
December 26 2023
Active Locations (1)
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1
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel