MalnutritionPhase 3NCT04398836
Preoperative Nutrition for Crohn's Disease Patients
A Phase 3 study testing Exclusive Enteral Nutrition, High energy / protein diet. and Standard nutrition in people with Malnutrition and Crohn Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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 general Crohn's Disease (CD) population. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malnutrition, Crohn Disease
- What is being tested?
- Exclusive Enteral Nutrition, High energy / protein diet. and Standard nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2020to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CD patients awaiting surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Tel Aviv
About this study
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.
Read the 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 the Department of Gastroenterology, from Surgery Department and from the Nutrition Unit in the Tel Aviv Medical Center (TLVMC).
Study procedure CD patients who are awaiting surgery will be screened and randomly assigned to the study. After the decision to perform surgery and patient's acceptance to participate in the study but not more than 3 months before scheduled surgery, patient will undergo nutritional assessment. Patients suffering from malnutrition will be randomly assigned to the EEN group or to the group receiving enriched high energy and protein diet. Well-nourished patients will continue with standard nutritional therapy. Malnutrition will be defined according to Subjective Global Assessment (SGA)
Screening procedure:
Patients assigned to the interventional arm would be asked to adhere to EEN for two days prior to inclusion in order to assess tolerability and adherence to the assigned diet. Those who are not able to adhere to a two day EEN diet , will be withdrawn from the interventional arm, and will be treated with a high energy, high protein diet as the control group in accordance to the study protocol.
Study group:
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 to achieve a concentration of 1 kcal per ml). During period patients guided to avoid eating and drinking anything but the enteral formula. The formula will be supplied to the patients by the investigators.
The formula used for this study will be VITAL - suitable for people with disease-related malnutrition and malabsorption. Vital 1.5kcal is peptide-based, nutritionally complete formulation for the dietary management of active phase of CD. VITAL includes all the nutritional macro and micronutrients and can serve as a sole source of nutrition. In cases of severe nutritional deterioration throughout the study, supplemental parenteral nutrition will be considered.
Control group:
Nutritional support by high energy/high protein diet, calculated by 25-30 kcal/kg and at least 1 gr/kg of protein. In cases of significant nutritional deterioration throughout the study, oral nutritional supplements or supplemental parenteral nutrition will be considered.
Well-nourished patient group: accepted standard nutritional therapy.
Compliance and dietary evaluation:
Patients will fill-up a 3 day food diary during every study visit to assesses recent dietary composition. Adherence to therapy will also monitored using the Medication Adherence Rating Scale (MARS) questionnaire.
Nutrients intake will be computed with the Israeli nutritional software "Zameret". Patients in the EEN group will be required to return the empty enteral formula containers.
Compliance to the diet instructed for the patient will be concidured as intake of 80% of calories per patient.
Compliance to the diet instructed for the patient will be concidured as intake of 80% of calories per patient.
Tolerability to EEN:
Tolerance will be defined as ingestion of the entire amount of formula requested by the patient without the development of any allergic/intolerant symptoms. Tolerance will be monitored during every study visit.
Disease activity:
Disease activity will be evaluated by serum C- Reactive Protein (CRP) concentration, fecal calprotectin concentration and Harvey-Bradshaw index (HBI).
Metabolic evaluation
Anthropometric measurements:
- Weight and height will be measured on a digital medical scale and body mass index (BMI) will be calculated.
- Handgrip strength will be measured by a handgrip dynamometer (JAMAR® - hydraulic hand dynamometer )
- Nutritional assessment by SGA questioners.
- Body composition by body electrical impedance.
- Resting Energy Expenditure (REE) will be measured by indirect calorimetry (Fitmate- Cosmed/ Italy)
Biochemical tests:
All blood samples will be drawn at the morning following 12 hours fast: albumin, blood count, serum CRP concentration and fecal calprotectin concentration.
Post operative clinical course:
Patient post-operative course will be documented from patients medical file. Parameters will include: hospitalization length, blood transfusions and other interventions, post operative medical treatment.
Fecal samples:
Stool will be analyzed for fecal calprotectin and for characterizing the microbial composition
Assessment of surgical complications
The following complications will be monitored 30d after surgery:
- Hospital readmissions
- Revision of surgery
- Stoma complications
- Severe bleeding
- Thrombotic event
- Ileus
- Liver complications
- Renal complications
- Infectious complications: Surgical site infection, Urinary tract infection, Pulmonary; anastomotic leaks, intraabdominal abscess and formation of new fistula.
Safety EEN is an accepted and recommended therapy for CD patients and considered a first-line therapy for inducing remission in children.
- Conditions
- Malnutrition, Crohn Disease
- Being tested
- Exclusive Enteral Nutrition, High energy / protein diet., Standard nutrition
- Medical subject headings
- Malnutrition, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exclusive Enteral NutritionDietary 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 to achieve a concentration of 1 kcal per ml). During this period patients will be guided to avoid eating and drinking anything but the enteral formula. The formula will be supplied to the patients by the investigators. The formula used for this study will be VITAL - suitable for people with disease-related malnutrition and malabsorption. Vital 1.5kcal is peptide-based, nutritionally complete formulation for the dietary management of active phase of Crohn's disease. VITAL includes all the nutritional macro and micronutrients and can serve as a sole source of nutrition.
High energy / protein diet.Other
Mulnourished patients will receive a high energy / protein diet.
Standard nutritionOther
Well nurished patients will receive a standard nutrition
| Study group | Role | What they receive |
|---|---|---|
| Malnourished patients - EEN | Active comparator | patiens will receive EEN for 4 week prior surgery Receives: Dietary Supplement: Exclusive Enteral Nutrition |
| Malnourished patients - enriched diet | Other | patiens will receive an enriched high energy and protein diet. Receives: Other: High energy / protein diet. |
| Well nourished patients | Other | Patient will receive a standard nutrition Receives: Other: Standard nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Compliance to diet
During every study visit compliance to diet instructed, monitor every week since initiating: week 0, week 4, 30 days post - surgery by 3 days food diary calculated average consumption of kcal and protein in grames.
The same assessment carried out at week 1, week 2, week 3, by 24 - hour recall questionnaire.
High Compliance considered if Calories > 80% protein ≥ 1 gr/kg from the expected metabolic assessment needs for each week 1-4 dietary intervention, and present better outcomes.
- using the MARS questionnaire - Medication Adherence Rating Scale. The patient should be asked to respond to the statements in the questionnaire by circling the answer which best describes their behaviour or attitude towards their medication during the past week.
- Patients will fill-up a 3 day food diary during every study visit to assesses recent dietary composition
Measured: during every study visit week 0, week 1, week 2, week 3, week 4, 30 days post - surgery
Changes in adherence to therapy
During every study visit week 1, week 2, week 3, week 4, 30 days post - surgery, MARS, Medication Adherence Rating Scale - questionnaire filled by subject: Patient asked to respond to the statements in the questionnaire by circling the answer best describes their behavior or attitude towards their diet prescription during the past week. Score range between: min of 10-19 - no adherence to diet, 40-49 often adherence, 50 max score present permanent adherence.
Measured: during every study visit week 1, week 2, week 3, week 4, 30 days post - surgery
Changes in tolerability to the diet
Tolerance will be monitored during every study visit week 0, week 1, week 2, week 3, week 4, as ingestion of the entire amount of formula requested by the patient without the development of any allergic/intolerant symptoms, report on changes in tolerance documented and monitored in tailored form.
Measured: Tolerance will be monitored during every study visit: week 0, week 1, week 2, week 3, week 4
Secondary outcomes (1)
The rate of post-operative complications in malnourished CD patients receiving pre-operative 4 weeks EEN, is changed during the 4 weeks post-surgery, compared to CD patients receiving high energy and protein diet without EEN one month after surgery.
Patient post-operative course documented from patients' medical file. Parameters include: hospitalization length, blood transfusions and other interventions, post - operative medical treatment and complications.
Measured: One month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study startSep 2020 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
- Investigators
- Nitsan Maharshak, MD, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398836
- Sponsor's protocol ID
- 0825-18TLV
- Status last verified
- May 2020
- First submitted
- 18 Jul 2019
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Nutrition for Crohn's Disease Patients
- ClinicalTrials.gov ID
- NCT04398836
- Acronym / sponsor ID
- 0825-18TLV
- Conditions
- Malnutrition, Crohn Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Sep 2020 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 the Department of Gastroenterology, from Surgery Department and from the Nutrition Unit in the Tel Aviv Medical Center (TLVMC).
Study procedure CD patients who are awaiting surgery will be screened and randomly assigned to the study. After the decision to perform surgery and patient's acceptance to participate in the study but not more than 3 months before scheduled surgery, patient will undergo nutritional assessment. Patients suffering from malnutrition will be randomly assigned to the EEN group or to the group receiving enriched high energy and protein diet. Well-nourished patients will continue with standard nutritional therapy. Malnutrition will be defined according to Subjective Global Assessment (SGA)
Screening procedure:
Patients assigned to the interventional arm would be asked to adhere to EEN for two days prior to inclusion in order to assess tolerability and adherence to the assigned diet. Those who are not able to adhere to a two day EEN diet , will be withdrawn from the interventional arm, and will be treated with a high energy, high protein diet as the control group in accordance to the study protocol.
Study group:
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 to achieve a concentration of 1 kcal per ml). During period patients guided to avoid eating and drinking anything but the enteral formula. The formula will be supplied to the patients by the investigators.
The formula used for this study will be VITAL - suitable for people with disease-related malnutrition and malabsorption. Vital 1.5kcal is peptide-based, nutritionally complete formulation for the dietary management of active phase of CD. VITAL includes all the nutritional macro and micronutrients and can serve as a sole source of nutrition. In cases of severe nutritional deterioration throughout the study, supplemental parenteral nutrition will be considered.
Control group:
Nutritional support by high energy/high protein diet, calculated by 25-30 kcal/kg and at least 1 gr/kg of protein. In cases of significant nutritional deterioration throughout the study, oral nutritional supplements or supplemental parenteral nutrition will be considered.
Well-nourished patient group: accepted standard nutritional therapy.
Compliance and dietary evaluation:
Patients will fill-up a 3 day food diary during every study visit to assesses recent dietary composition. Adherence to therapy will also monitored using the Medication Adherence Rating Scale (MARS) questionnaire.
Nutrients intake will be computed with the Israeli nutritional software "Zameret". Patients in the EEN group will be required to return the empty enteral formula containers.
Compliance to the diet instructed for the patient will be concidured as intake of 80% of calories per patient.
Compliance to the diet instructed for the patient will be concidured as intake of 80% of calories per patient.
Tolerability to EEN:
Tolerance will be defined as ingestion of the entire amount of formula requested by the patient without the development of any allergic/intolerant symptoms. Tolerance will be monitored during every study visit.
Disease activity:
Disease activity will be evaluated by serum C- Reactive Protein (CRP) concentration, fecal calprotectin concentration and Harvey-Bradshaw index (HBI).
Metabolic evaluation
Anthropometric measurements:
- Weight and height will be measured on a digital medical scale and body mass index (BMI) will be calculated.
- Handgrip strength will be measured by a handgrip dynamometer (JAMAR® - hydraulic hand dynamometer )
- Nutritional assessment by SGA questioners.
- Body composition by body electrical impedance.
- Resting Energy Expenditure (REE) will be measured by indirect calorimetry (Fitmate- Cosmed/ Italy)
Biochemical tests:
All blood samples will be drawn at the morning following 12 hours fast: albumin, blood count, serum CRP concentration and fecal calprotectin concentration.
Post operative clinical course:
Patient post-operative course will be documented from patients medical file. Parameters will include: hospitalization length, blood transfusions and other interventions, post operative medical treatment.
Fecal samples:
Stool will be analyzed for fecal calprotectin and for characterizing the microbial composition
Assessment of surgical complications
The following complications will be monitored 30d after surgery:
- Hospital readmissions
- Revision of surgery
- Stoma complications
- Severe bleeding
- Thrombotic event
- Ileus
- Liver complications
- Renal complications
- Infectious complications: Surgical site infection, Urinary tract infection, Pulmonary; anastomotic leaks, intraabdominal abscess and formation of new fistula.
Safety EEN is an accepted and recommended therapy for CD patients and considered a first-line therapy for inducing remission in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Malnourished patients - EEN | Active comparator | Dietary Supplement: Exclusive Enteral Nutritionpatiens will receive EEN for 4 week prior surgery |
| Malnourished patients - enriched diet | Other | Other: High energy / protein diet.patiens will receive an enriched high energy and protein diet. |
| Well nourished patients | Other | Other: Standard nutritionPatient will receive a standard nutrition |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CD patients awaiting surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exclusive Enteral NutritionMulnourished 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 to achieve a concentration of 1 kcal per ml). During this period patients will be guided to avoid eating and drinking anything but the enteral formula. The formula will be supplied to the patients by the investigators. The formula used for this study will be VITAL - suitable for people with disease-related malnutrition and malabsorption. Vital 1.5kcal is peptide-based, nutritionally complete formulation for the dietary management of active phase of Crohn's disease. VITAL includes all the nutritional macro and micronutrients and can serve as a sole source of nutrition. | Dietary supplement | Malnourished patients - EEN |
| High energy / protein diet.Mulnourished patients will receive a high energy / protein diet. | Other | Malnourished patients - enriched diet |
| Standard nutritionWell nurished patients will receive a standard nutrition | Other | Well nourished patients |
Primary outcome
Changes in Compliance to diet
Time frame: during every study visit week 0, week 1, week 2, week 3, week 4, 30 days post - surgery
During every study visit compliance to diet instructed, monitor every week since initiating: week 0, week 4, 30 days post - surgery by 3 days food diary calculated average consumption of kcal and protein in grames. The same assessment carried out at week 1, week 2, week 3, by 24 - hour recall questionnaire. High Compliance considered if Calories > 80% protein ≥ 1 gr/kg from the expected metabolic assessment needs for each week 1-4 dietary intervention, and present better outcomes. 1. using the MARS questionnaire - Medication Adherence Rating Scale. The patient should be asked to respond to the statements in the questionnaire by circling the answer which best describes their behaviour or attitude towards their medication during the past week. 2. Patients will fill-up a 3 day food diary during every study visit to assesses recent dietary composition
Changes in adherence to therapy
Time frame: during every study visit week 1, week 2, week 3, week 4, 30 days post - surgery
During every study visit week 1, week 2, week 3, week 4, 30 days post - surgery, MARS, Medication Adherence Rating Scale - questionnaire filled by subject: Patient asked to respond to the statements in the questionnaire by circling the answer best describes their behavior or attitude towards their diet prescription during the past week. Score range between: min of 10-19 - no adherence to diet, 40-49 often adherence, 50 max score present permanent adherence.
Changes in tolerability to the diet
Time frame: Tolerance will be monitored during every study visit: week 0, week 1, week 2, week 3, week 4
Tolerance will be monitored during every study visit week 0, week 1, week 2, week 3, week 4, as ingestion of the entire amount of formula requested by the patient without the development of any allergic/intolerant symptoms, report on changes in tolerance documented and monitored in tailored form.
1 secondary outcome
The rate of post-operative complications in malnourished CD patients receiving pre-operative 4 weeks EEN, is changed during the 4 weeks post-surgery, compared to CD patients receiving high energy and protein diet without EEN one month after surgery.
Time frame: One month after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nitsan Maharshak, MD principal investigator
Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exclusive Enteral Nutrition, High energy / protein diet. and Standard nutrition in people with Malnutrition and Crohn Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naomi Fliss, PhD (97236974924, naomifl@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Compliance to diet (time frame: during every study visit week 0, week 1, week 2, week 3, week 4, 30 days post - surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.