Not yet taking people in IsraelPhase 3

Liquid Nutrition Before Bowel Surgery in Crohn's Disease

Tests a liquid-only feeding plan before surgery in malnourished adults with Crohn's disease.

Key facts

Who runs it: Tel-Aviv Sourasky Medical Center
Where: Tel Aviv, IsraelSee the site
Trial code: NCT04398836
Registry title: Preoperative Nutrition for Crohn's Disease Patients
Status: Not yet recruiting
Phase: Phase 3
People taking part: 144 people, planned
Started: Sept 2020
Expected to end: Dec 2027
Type of study: Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Exclusive Enteral Nutrition
High energy / protein diet.
Standard nutrition
Record updated: 21 May 2020

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Crohn's disease who are waiting for bowel surgery. It tests whether special nutrition before surgery helps.

Age: 18 to 70 years
Sex: All sexes can join.
Disease stage: Crohn's disease, waiting for surgery.
Earlier treatment: People on total parenteral nutrition (TPN, feeding through a vein) cannot join.

Main reasons for not taking part

Pregnancy or breastfeeding
On total parenteral nutrition (TPN)
Cancer, organ transplant, advanced kidney or liver disease, or inflammatory conditions other than IBD
Cannot sign the consent form or complete the study
Surgery to reverse an ileostomy or colostomy, or to drain an abscess

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

CD patients awaiting surgery

Who cannot take part

Surgical procedure to reverse ileostomy/colostomy or abscess drainage
Subjects with chronic conditions such as cancer, organ transplant subjects, advanced kidney or liver disease, systemic inflammatory conditions other than IBD
Pregnancy and lactation
Subjects on TPN
Inability to sign informed consent and complete study protocol

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 70 years old?

Where in Israel

Dep. of Gastroenterology, Tel Aviv Sourasky Medical CenterTel Aviv, IsraelContact: Naomi Fliss, PhDNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 3 groups in the trial

Malnourished patients - EENExisting treatment, for comparison
patiens will receive EEN for 4 week prior surgery
Treatment: Exclusive Enteral Nutrition
Malnourished patients - enriched dietOther group
patiens will receive an enriched high energy and protein diet.
Treatment: High energy / protein diet.
Well nourished patientsOther group
Patient will receive a standard nutrition
Treatment: Standard nutrition