Taking people in IsraelNo phase

Tests infrared light treatment in adults with Crohn's disease

Tests far infrared light therapy at different strengths against sham in Crohn's disease.

Key facts

Who runs it: Shmuel Kivity, MD
Where: Tel Aviv, IsraelSee the site
Trial code: NCT06146816
Registry title: The Assessment of Infrared Treatment for Crohn's Disease
Status: Recruiting
People taking part: 40 people, planned
Started: 12 Sept 2023
Expected to end: Jan 2028
Type of study: Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested: High level photobiomodulation treatment in the infrared (IR) range.
Medium level photobiomodulation treatment in the far infrared (IR) range
Low level photobiomodulation treatment in the far infrared (IR) range
Photobiomodulation sham treatment
Record updated: 24 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with established Crohn's disease and active symptoms or signs of inflammation. It tests far infrared light therapy, given in 10 treatments.

Age: Older than 18 and younger than 80 years.
Sex: All sexes can join.
Disease stage: Established Crohn's disease with a Harvey-Bradshaw index symptom score above 4 and/or fecal calprotectin above 150 ug/gr.
Earlier treatment: No treatment, or a steady medicine plan during 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.
Biomarker or test result: Fecal calprotectin above 150 ug/gr (or a Harvey-Bradshaw index score above 4).

Main reasons for not taking part

BMI greater than 30 Kg/m2
A proven current infection, such as Clostridioides difficile, a positive stool culture or parasites
Pregnancy
Chronic conditions such as cancer, organ transplant, advanced kidney or liver disease, or systemic inflammatory conditions other than IBD
Abdominal abscess or entero-enteric fistula, or abscess and cysts in the liver, kidneys or pancreas

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

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

Who cannot take part

More than one CD luminal surgery or a small bowel length < 1.5 meter
Any proven current infection such as Clostridioides difficile infection, positive stool culture, or parasites
Subjects with chronic conditions such as cancer, organ transplant subjects, advanced kidney or liver disease, systemic inflammatory conditions other than IBD
Evidence of an abdominal abscess or entero-enteric fistula
BMI greater than 30 Kg/m2
Inability to sign informed consent and complete study protocol
Pregnancy
Presence of abscess and cysts in the liver/ kidneys or pancreas

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 80 years old?

Where in Israel

Dep. of Gastroenterology, Tel Aviv Sourasky Medical CenterTel Aviv, IsraelContact: Nitsan Mahrshak, MDTaking people

About the trial

What the trial wants to find out

The goal of this clinical trial is to test the safety and efficacy of far Infra-red (fIR) therapy in Crohn's disease patients.

Read full original descriptionShow less

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.

The 4 groups in the trial

High intensity fIR therapyTreatment being tested
Patients will undergo 10 sessions of 30 minutes high intensity (approximately 70˚C) fIR therapy at the IBD clinic of the TLVMC by a trained and qualified staff member. Each abdominal quadrant will receive a similar amount of time of exposure to the IR, except for the quadrant of the inflamed intestine (usually the right lower quadrant) which will be exposed longer to the IR. During the treatment, energy levels and skin temperature will be recorded at 10 minutes intervals. Patients responding to therapy (clinical response: ∆HBI≥3 and/or 50% reduction in calprotectin), who did not achieve remission can continue for 10 more treatments.
Treatment: High level photobiomodulation treatment in the infrared (IR) range.
Placebo armPlacebo, for comparison
Patients will undergo 10 sessions of 30 minutes of placebo treatment, at the IBD clinic of the TLVMC by a trained and qualified staff member. Each abdominal quadrant will receive a similar amount of time of exposure, except for the quadrant of the inflamed intestine (usually the right lower quadrant) which will be exposed longer. During the treatment, energy levels and skin temperature will be recorded at 10 minutes intervals.
Treatment: Photobiomodulation sham treatment
Low intensity fIR therapyTreatment being tested
Patients will undergo 10 sessions of 30 minutes of low intensity (approximately 45˚C) fIR therapy at the IBD clinic of the TLVMC by a trained and qualified staff member. Each abdominal quadrant will receive a similar amount of time of exposure to the IR, except for the quadrant of the inflamed intestine (usually the right lower quadrant) which will be exposed longer to the IR. During the treatment, energy levels and skin temperature will be recorded at 10 minutes intervals. Patients responding to therapy (clinical response: ∆HBI≥3 and/or 50% reduction in calprotectin), who did not achieve remission can continue for 10 more treatments.
Treatment: Low level photobiomodulation treatment in the far infrared (IR) range
Medium intensity fIR therapyTreatment being tested
Patients will undergo 10 sessions of 30 minutes of medium intensity (approximately 60˚C) fIR therapy at the IBD clinic of the TLVMC by a trained and qualified staff member. Each abdominal quadrant will receive a similar amount of time of exposure to the IR, except for the quadrant of the inflamed intestine (usually the right lower quadrant) which will be exposed longer to the IR. During the treatment, energy levels and skin temperature will be recorded at 10 minutes intervals. Patients responding to therapy (clinical response: ∆HBI≥3 and/or 50% reduction in calprotectin), who did not achieve remission can continue for 10 more treatments.
Treatment: Medium level photobiomodulation treatment in the far infrared (IR) range