The Assessment of Infrared Treatment for Crohn's Disease

NCT06146816 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-24

No results posted yet for this 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.

Conditions

  • IBD
  • Inflammatory Bowel Diseases
  • Crohn Disease

Interventions

DEVICE

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

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

DEVICE

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

DEVICE

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

DEVICE

Photobiomodulation sham treatment

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

Sponsors & Collaborators

  • Shmuel Kivity, MD

    lead OTHER_GOV

Principal Investigators

  • Nitsan Maharshak, Professor · Department of Gastroenterology and Liver Diseases, Tel Aviv Medical Center, Tel Aviv, Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-12
Primary Completion
2027-09-30
Completion
2028-01-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06146816 on ClinicalTrials.gov