Photopill Treatment in Healthy Volunteers

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status and phase: Completed; Phase 1

Conditions: Ulcerated Mucosa of Colon

Treatments: Device: Photopill treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01702662

METC2012_150, ABR: 40642

Details and patient eligibility

About

Photo-bio-stimulation by Low Level Light therapy(LLLT) has demonstrated its clinical use in chemotherapy/radiotherapy oral mucositis.

Unpublished study (Melzer, Ben-Yehuda et al. UEGW 2012) with the Photopill (LLLT) capsule treatment in mice showed a significant beneficial effect on the endoscopic severity of DSS-induced colitis in mice.

Therefore a phase 1 trial is designed to assess the safety and feasibility of the Photopill treatment in healthy volunteers.

Enrollment: 4 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who are generally healthy.
• Signed informed consent.

Exclusion criteria

• Subjects with any known GI related symptoms complaints or GI diseases.
• Subjects with cancer or other life threatening diseases or conditions.
• Subjects with cardiovascular or pulmonary diseases.
• Pregnant women.
• Subjects who underwent any colon surgery.
• Morbid Obesity (BMI > 40).
• Drug abuse or alcoholism.
• Bed-ridden patient.
• Any rectal therapy.
• Participation in current clinical study or clinical study within 30 days prior to the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Photopill treatment

Experimental group

Description:

Photopill treatment, 2 minutes per cm rectal mucosa (3cm) 10 times

Treatment:

Device: Photopill treatment