Testing infrared therapy for Crohn's disease
An Exploratory Clinical Trial for the Assessment of Infrared Treatment for Crohn's Disease
This study is testing if far infrared therapy can help people with Crohn's disease feel better compared to a placebo treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tel-Aviv Sourasky Medical Center Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Tel Aviv) |
| Trial ID | NCT06146816 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of far infrared (fIR) therapy in patients with Crohn's disease. Participants will undergo 10 sessions of fIR therapy and provide stool and blood samples, along with completing questionnaires. The study will compare high intensity fIR therapy against a placebo to determine if it can effectively reduce symptoms associated with Crohn's disease. The trial seeks to explore a novel treatment approach that could offer an alternative to traditional immune-modulating drugs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with an established diagnosis of Crohn's disease and specific symptom severity.
Not a fit: Patients with a BMI over 30 or those with active infections or other chronic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a non-invasive treatment option for patients suffering from Crohn's disease.
How similar studies have performed: Preliminary data suggest positive effects of infrared therapy on Crohn's disease, but this approach is still being clinically explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tel Aviv
- Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (Recruiting)
Study contacts
- Principal investigator: Nitsan Maharshak, Professor — Department of Gastroenterology and Liver Diseases, Tel Aviv Medical Center, Tel Aviv, Israel
- Study coordinator: Nitsan Maharshak, Professor
- Email: nitsanm@tlvmc.gov.il
- Phone: +972527360384
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.