The Assessment of Infrared Treatment for Crohn's Disease
An Exploratory Clinical Trial for the Assessment of Infrared Treatment for Crohn's Disease
Shmuel Kivity, MD
40 participants
Sep 12, 2023
INTERVENTIONAL
Conditions
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 for treating Crohn's disease patients? 2. Is infrared therapy effective for treating Crohn's disease? Participants will be asked to attend 10 treatments of fIR therapy, provide stool and blood samples and answer questionnaires. Researchers will compare between 4 treatments: three intensities of fIR therapy and placebo treatment to explore which intensity is most effective for treating Crohn's disease.
Eligibility
Inclusion Criteria4
- An established Crohn's disease
- \< 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 Criteria8
- 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
Interventions
The baseline treatment included 10 weekly 30 minutes long sessions of high level fIR treatment.
The baseline treatment included 10 weekly 30 minutes long session of medium level fIR treatments
The baseline treatment included 10 weekly 30 minutes long session of low level fIR treatments
The baseline treatment includes 10 weekly 30 minutes long of sham fIR treatment.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06146816