The Assessment of Infrared Treatment for Crohn's Disease
Not applicable · Testing High level photobiomodulation treatment in the infrared (IR) range., Medium level… · 1 site · Shmuel Kivity, MD
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing High level photobiomodulation treatment in the infrared (IR) range. (a device), Medium level photobiomodulation treatment in the far infrared (IR) range (a device) and Low level photobiomodulation treatment in the far infrared (IR) range (a device) as a possible treatment. Condition(s) listed: IBD, Inflammatory Bowel Diseases and Crohn Disease.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 80
- Any sex
Some of the main requirements, copied from the record:
- 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…
Plus 1 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2023-09-12.
- Main results expected around 2027-09 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Israel.
Main thing being measured
- Assess the safety of fIR therapy for CD patients. (2 years)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | IBD; Inflammatory Bowel Diseases; Crohn Disease |
| Lead sponsor | Shmuel Kivity, MD |
| Enrollment | 40 (estimated) |
| Start date | 2023-09-12 |
| Primary completion (est.) | 2027-09 |
| First posted | 2023-11-27 |
| Last updated | 2026-02-24 |
| Official title | An Exploratory Clinical Trial for the Assessment of Infrared Treatment for Crohn's Disease |
| ClinicalTrials.gov ID | NCT06146816 |
Interventions
- High level photobiomodulation treatment in the infrared (IR) range. (Device)
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 (Device)
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 (Device)
The baseline treatment included 10 weekly 30 minutes long session of low level fIR treatments - Photobiomodulation sham treatment (Device)
The baseline treatment includes 10 weekly 30 minutes long of sham fIR treatment.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center | Tel Aviv | Israel | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.