The Assessment of Infrared Treatment for Crohn's Disease

Recruiting now · Not applicable · Has a placebo group

Conditions studied: IBD, Inflammatory Bowel Diseases, Crohn Disease

In brief

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.

Key facts

Study ID

NCT06146816

Run by

Shmuel Kivity, MD

People needed

40

Starts

2023-09-12

Expected to finish

2028-01-01

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (enrolling)

Full record on ClinicalTrials.gov

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