Preoperative Nutrition for Crohn's Disease Patients
Phase 3 · Testing Exclusive Enteral Nutrition, High energy / protein diet. and Standard nutrition · 1 site · Tel-Aviv Sourasky Medical Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Exclusive Enteral Nutrition (a dietary supplement), High energy / protein diet. and Standard nutrition as a possible treatment. Condition(s) listed: Malnutrition and Crohn Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- CD patients awaiting surgery
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 144 participants are expected to take part.
- Start date: 2020-09 (planned).
- Main results expected around 2023-07 (estimate from the record).
- 1 study site listed in Israel.
Main thing being measured
- Changes in Compliance to diet (during every study visit week 0, week 1, week 2, week 3, week 4, 30 days post - surgery)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Malnutrition; Crohn Disease |
| Lead sponsor | Tel-Aviv Sourasky Medical Center |
| Enrollment | 144 (estimated) |
| Start date | 2020-09 |
| Primary completion (est.) | 2023-07 |
| First posted | 2020-05-21 |
| Last updated | 2020-05-21 |
| Official title | Preoperative Nutrition for Crohn's Disease Patients |
| ClinicalTrials.gov ID | NCT04398836 |
Interventions
- Exclusive Enteral Nutrition (Dietary Supplement)
Mulnourished patients will drink an enteral polymeric formula suited to their energy expenditure calculated by 25-30 kcal/kg and at least 1 gr/kg of protein, a minimum of 1500 ml (1500 kcal, 54 gr of protein). The amount of formula to achieve nutritional requirements are based on body weight, but the average intake is of 6-8 cups of formula (36-48 scoops of formula mixed with 1260-1680 ml of water… - High energy / protein diet. (Other)
Mulnourished patients will receive a high energy / protein diet. - Standard nutrition (Other)
Well nurished patients will receive a standard nutrition
Full eligibility criteria (from the record)
Inclusion Criteria: • CD patients awaiting surgery Exclusion Criteria: * 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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center | Tel Aviv | Israel |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.