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Recruiting Not applicable

The Assessment of Infrared Treatment for Crohn's Disease

NCT06146816 · tracked via the Priya Life Science Israel tracker
Sponsor
Shmuel Kivity, MD
Phase
Not applicable
Started
2023-09-12
Last updated
2026-02-24

Condition(s) studied

IBDInflammatory Bowel DiseasesCrohn Disease

Investigational drug(s) / intervention(s)

High level photobiomodulation treatment in the infrared (IR) range.Medium level photobiomodulation treatment in the far infrared (IR) rangeLow level photobiomodulation treatment in the far infrared (IR) rangePhotobiomodulation sham treatment

High level photobiomodulation treatment in the infrared (IR) range.: The baseline treatment included 10 weekly 30 minutes long sessions of high level fIR treatment.

Medium level photobiomodulation treatment in the far infrared (IR) range: The baseline treatment included 10 weekly 30 minutes long session of medium level fIR treatments

Low level photobiomodulation treatment in the far infrared (IR) range: The baseline treatment included 10 weekly 30 minutes long session of low level fIR treatments

Photobiomodulation sham treatment: The baseline treatment includes 10 weekly 30 minutes long of sham fIR treatment.

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Assess the safety of fIR therapy for CD patients. — 2 years
    The investigator will document all adverse events and assess their severity. The only documented adverse event for fIR treatment in the currently available literature are first degree burns. Hence, the treatment will be considered safe if no additional adverse events will occur. Clinical and biochemical markers will be monitored for the possibility of disease exacerbation following fIR treatment.

Trial sites (1)

FacilityCityRegionStatus
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center Tel Aviv Israel Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06146816 on ClinicalTrials.gov ↗ ← All trials in Israel