Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06146816

The Assessment of Infrared Treatment for Crohn's Disease

Led by Shmuel Kivity, MD · Updated on 2026-02-24

40

Participants Needed

1

Research Sites

224 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Assessment of Infrared Treatment for Crohn's Disease

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with Crohn's disease
  • Age between 18 and 80 years
  • Either not receiving therapy or on a stable medication regimen throughout the study: mesalamine for at least 6 weeks, steroids for at least 2 weeks, immunomodulatory drugs for at least 12 weeks, biologics for at least 12 weeks, or medical cannabis for at least 2 weeks before the study
  • Symptoms score greater than 4 on the Harvey-Bradshaw index or fecal calprotectin level over 150 ug/gr
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) greater than 30 kg/m2
  • Current infections such as Clostridioides difficile infection, positive stool culture, or parasites
  • Unable to sign informed consent or complete the study protocol
  • Pregnancy
  • Chronic conditions including cancer, organ transplant, advanced kidney or liver disease, or systemic inflammatory conditions other than inflammatory bowel disease
  • Presence of abscesses or cysts in the liver, kidneys, or pancreas
  • Evidence of abdominal abscess or entero-enteric fistula
  • More than one Crohn's disease luminal surgery or small bowel length less than 1.5 meters

AI-Screening

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Trial Site Locations

Total: 1 location

1

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Actively Recruiting

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Research Team

N

Nitsan Maharshak, Professor

CONTACT

R

Rony Izhar, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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