RecruitingNot ApplicableNCT06146816

The Assessment of Infrared Treatment for Crohn's Disease

An Exploratory Clinical Trial for the Assessment of Infrared Treatment for Crohn's Disease


Sponsor

Shmuel Kivity, MD

Enrollment

40 participants

Start Date

Sep 12, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether infrared light therapy (a non-invasive treatment using infrared radiation applied to the abdomen) can reduce inflammation and improve symptoms in people with Crohn's disease. **You may be eligible if...** - You are between 18 and 80 years old - You have an established diagnosis of Crohn's disease - You are either not taking medications or have been on a stable treatment regimen for several months - Your symptoms are moderate or above on a standard scoring system, or you have elevated markers of inflammation in your stool **You may NOT be eligible if...** - Your BMI is over 30 - You have a current gastrointestinal infection (e.g., C. difficile) - You are pregnant - You have cancer, an organ transplant, advanced kidney or liver disease, or another serious systemic inflammatory condition - You have an abscess or cyst in the liver, kidneys, or pancreas - You have an abdominal abscess or a fistula between loops of intestine - You have had more than one bowel surgery or have a very short remaining small intestine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHigh level photobiomodulation treatment in the infrared (IR) range.

The baseline treatment included 10 weekly 30 minutes long sessions of high level fIR treatment.

DEVICEMedium level photobiomodulation treatment in the far infrared (IR) range

The baseline treatment included 10 weekly 30 minutes long session of medium level fIR treatments

DEVICELow level photobiomodulation treatment in the far infrared (IR) range

The baseline treatment included 10 weekly 30 minutes long session of low level fIR treatments

DEVICEPhotobiomodulation sham treatment

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


Locations(1)

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

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NCT06146816


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