NCT04398836Not yet recruitingPhase 3
Preoperative Nutrition for Crohn's Disease Patients
Source: ClinicalTrials.gov · Last updated 21 May 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The investigator hypothesizes that compliance to Exclusive enteral nutrition (EEN) will be high among patients on an operation for their bowel disease, compared to the compliance rate seen in the general Crohn's Disease (CD) population. Also,the investigator hypothesizes that clinical outcomes would improve, and post-operative complication rate will be reduces in malnourished CD patients receiving pre-operative 4 weeks EEN during the 4 weeks post-surgery, compared to CD patients receiving high energy and protein diet without EEN.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 18 Jul 2019
- Start date
- Sept 2020
- Primary completion date
- Jul 2023
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Diseases
- Crohn's disease
- NCT number
- NCT04398836
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 144
- From Sept 2020 to the primary completion date, Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgical procedure to reverse ileostomy/colostomy or abscess drainage
Other illness
- Subjects with chronic conditions such as cancer, organ transplant subjects, advanced kidney or liver disease, systemic inflammatory conditions other than IBD
Other
- Pregnancy and lactation
- Subjects on TPN
- Inability to sign informed consent and complete study protocol
Who the study is looking for
- CD patients awaiting surgery
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.