Testing infrared therapy for Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of far infrared (fIR) therapy in patients with Crohn's disease. Participants will undergo 10 sessions of fIR therapy and provide stool and blood samples, along with completing questionnaires. The study will compare high intensity fIR therapy against a placebo to determine if it can effectively reduce symptoms associated with Crohn's disease. The trial seeks to explore a novel treatment approach that could offer an alternative to traditional immune-modulating drugs.

Why it matters

Who can join: the full rules

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

Where it's running

• Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
  Tel Aviv, Israel Recruiting

Study contacts

• Principal investigator: Nitsan Maharshak, Professor — Department of Gastroenterology and Liver Diseases, Tel Aviv Medical Center, Tel Aviv, Israel
• Study coordinator: Nitsan Maharshak, Professor
• Email: nitsanm@tlvmc.gov.il
• Phone: +972527360384

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.