Characterization of a macrophage population under the control of nerves in the gastrointestinal tract
Phase 1
- Conditions
- Patients undergoing colorectal surgery due to benign or malignant carcinoma, diverticulitis or constipationdrug will be used to differentiate between macrophages that are modulated by enteric neurons and those that are notTherapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2018-002192-18-BE
- Lead Sponsor
- KU Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Patients above 18 years old undergoing colorectal surgery due to benign or malignant carcinoma, diverticulitis or constipation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
•Adjuvant radiotherapy
•Evident intra-abdominal inflammation (diagnosed by CT/RX or lab results)
• ‘American Society of Anesthesiologists physical-health status classification’ (ASA-PS) >3
•Uncontrolled diabetes (>200 mg/dl (=11mmol/l))
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Characterization of the macrophage population subset that is modulated by enteric neurons;Secondary Objective: Not applicable;Primary end point(s): Characterization of the macrophage population subset that is modulated by enteric neurons via RNA sequencing;Timepoint(s) of evaluation of this end point: Not applicable
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable