Status:
NOT_YET_RECRUITING
Preoperative Nutrition for Crohn's Disease Patients
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
Malnutrition
Crohn Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 gene...
Detailed Description
Study design: A randomized, none-blinded study. Study population: 144 CD patients designated for surgery, 96 malnourished patients and 44 well-nourished patients. Participants will be recruited from ...
Eligibility Criteria
Inclusion
- • CD patients awaiting surgery
Exclusion
- Pregnancy and lactation
- Subjects on TPN
- Subjects with chronic conditions such as cancer, organ transplant subjects, advanced kidney or liver disease, systemic inflammatory conditions other than IBD
- Inability to sign informed consent and complete study protocol
- Surgical procedure to reverse ileostomy/colostomy or abscess drainage
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04398836
Start Date
September 1 2020
End Date
December 1 2027
Last Update
May 21 2020
Active Locations (1)
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1
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel