Crohn DiseaseSEPEN-CDNCT06587178
Semi-elemental Versus Polymeric EEN in the Preoperative Optimization for Patients with CD
A study testing peptison liquid and Enteral nutritional suspension in people with Crohn Disease and Nutrition Disorders, run by Wei Zhou at 1 site in China.
Trial summary
Growing evidence has shown that exclusive enteral nutrition (EEN) plays an important role in the preoperative optimization for patients with Crohn's disease (CD). However, the efficacy and safety of different types of enteral feeds including semi-elemental and polymeric enteral nutrition on CD have not been… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease, Nutrition Disorders, Surgery
- What is being tested?
- peptison liquid and Enteral nutritional suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective bowel resection for Crohn's disease;
- preoperative diagnosis of Crohn's disease;
- age between 18 to 65 years old;
- malnutrition;
- the Crohn's disease activity index over 150;
- nasal feeding.
Who cannot join
- emergency surgery;
- preoperative exclusive enteral nutrition before three months;
- can not tolerate enteral nutrition;
- less than 6 weeks of exclusive enteral nutrition;
- preoperative corticosteroids within 3 months;
- history of gastrointestinal surgery;
- isolated colon disease;
- metabolic disease (diabetes, hyperthyroidism).
Trial locations and contacts
1 site in 1 country.
China1 site
Wei Zhou
Hangzhou, Zhejiang, 310016
Xiaolong Ge, +86-13867106984, gxlmed@zju.edu.cn
About this study
Official title: Semi-elemental Versus Polymeric Exclusive Enteral Nutrition in the Preoperative Optimization for Patients with Crohn's Disease: a Randomized Controlled Trial
Growing evidence has shown that exclusive enteral nutrition (EEN) plays an important role in the preoperative optimization for patients with Crohn's disease (CD). However, the efficacy and safety of different types of enteral feeds including semi-elemental and polymeric enteral nutrition on CD have not been investigated. The aim of this study was to compare the role of semi-elemental and polymeric enteral nutrition on CD.
Read the detailed description
Growing evidence has shown that exclusive enteral nutrition (EEN) plays an important role in the preoperative optimization for patients with Crohn's disease (CD). However, the efficacy and safety of different types of enteral feeds including semi-elemental and polymeric enteral nutrition on CD have not been investigated. The aim of this study was to compare the role of semi-elemental and polymeric enteral nutrition on CD. The primary outcome: the reduction rate of CRP/ALB after exclusive enteral nutrition in Crohn's disease. The other outcomes: (1) the changes in Crohn's disease activity index; (2) the tolerance of enteral nutrition; (3) the changes in body mass index; (4) postoperative complications and the incidence of stoma; (5) the rate of surgery; (6) other adverse reactions.
- Conditions
- Crohn Disease, Nutrition Disorders, Surgery
- Being tested
- peptison liquid, Enteral nutritional suspension
- Keywords
- Crohn's disease, Exclusive enteral nutrition, surgery
- Medical subject headings
- Crohn Disease, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peptison liquidDietary supplement
Also called Nutricia, Amsterdam, Netherlands
CD patients requiring bowel resection and preoperative EEN were randomized to receive peptison liquid for 6 weeks.
Enteral nutritional suspensionDietary supplement
Also called Nutricia, Amsterdam, Netherlands
CD patients requiring bowel resection and preoperative EEN were randomized to receive enteral nutritional suspension for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SED patient | Experimental | SED patients who received semi-elemental exclusive enteral nutrition. Receives: Dietary Supplement: peptison liquid |
| PD patient | Placebo comparator | PD patients who received polymeric exclusive enteral nutrition. Receives: Dietary Supplement: Enteral nutritional suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of CRP/ALB level
The ratio of C-reactive protein to albumin level changed after exclusive enteral nutrition.
Measured: 6 weeks
Secondary outcomes (4)
BMI
The BMI level changed after exclusive enteral nutrition.
Measured: 6 weeks
CDAI
Crohn's disease activity index, from 0 to 600, the higher index shows more serious of CD.
Measured: 6 weeks
postoperative complications
The incidence of postoperative complications in two groups.
Measured: 6 weeks
adverse reaction
The incidence of adverse reaction during exclusive enteral nutrition.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Zhou, Sir Run Run Shaw Hospital
- Investigators
- Xiujun Cai, Study chair, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587178
- Sponsor's protocol ID
- 20210323-11
- Acronym
- SEPEN-CD
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data can be available from the email (gxlmed@zju.edu.cn)
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semi-elemental Versus Polymeric Exclusive Enteral Nutrition in the Preoperative Optimization for Patients with Crohn's Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06587178
- Acronym / sponsor ID
- SEPEN-CD / 20210323-11
- Conditions
- Crohn Disease, Nutrition Disorders, Surgery
- Keywords
- Crohn's disease, Exclusive enteral nutrition, surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Wei ZhouUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
Growing evidence has shown that exclusive enteral nutrition (EEN) plays an important role in the preoperative optimization for patients with Crohn's disease (CD). However, the efficacy and safety of different types of enteral feeds including semi-elemental and polymeric enteral nutrition on CD have not been investigated. The aim of this study was to compare the role of semi-elemental and polymeric enteral nutrition on CD.
Detailed description
Growing evidence has shown that exclusive enteral nutrition (EEN) plays an important role in the preoperative optimization for patients with Crohn's disease (CD). However, the efficacy and safety of different types of enteral feeds including semi-elemental and polymeric enteral nutrition on CD have not been investigated. The aim of this study was to compare the role of semi-elemental and polymeric enteral nutrition on CD. The primary outcome: the reduction rate of CRP/ALB after exclusive enteral nutrition in Crohn's disease. The other outcomes: (1) the changes in Crohn's disease activity index; (2) the tolerance of enteral nutrition; (3) the changes in body mass index; (4) postoperative complications and the incidence of stoma; (5) the rate of surgery; (6) other adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SED patient | Experimental | Dietary Supplement: peptison liquidSED patients who received semi-elemental exclusive enteral nutrition. |
| PD patient | Placebo comparator | Dietary Supplement: Enteral nutritional suspensionPD patients who received polymeric exclusive enteral nutrition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- elective bowel resection for Crohn's disease;
- preoperative diagnosis of Crohn's disease;
- age between 18 to 65 years old;
- malnutrition;
- the Crohn's disease activity index over 150;
Key exclusion criteria (8 listed)
- emergency surgery;
- preoperative exclusive enteral nutrition before three months;
- can not tolerate enteral nutrition;
- less than 6 weeks of exclusive enteral nutrition;
- preoperative corticosteroids within 3 months;
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 |
|---|---|---|
| peptison liquidAlso: Nutricia, Amsterdam, NetherlandsCD patients requiring bowel resection and preoperative EEN were randomized to receive peptison liquid for 6 weeks. | Dietary supplement | SED patient |
| Enteral nutritional suspensionAlso: Nutricia, Amsterdam, NetherlandsCD patients requiring bowel resection and preoperative EEN were randomized to receive enteral nutritional suspension for 6 weeks. | Dietary supplement | PD patient |
Primary outcome
The change of CRP/ALB level
Time frame: 6 weeks
The ratio of C-reactive protein to albumin level changed after exclusive enteral nutrition.
4 secondary outcomes
BMI
Time frame: 6 weeks
CDAI
Time frame: 6 weeks
postoperative complications
Time frame: 6 weeks
adverse reaction
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. The data can be available from the email (gxlmed@zju.edu.cn)
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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. This study is not recruiting at the moment.
Xiujun Cai study chair
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peptison liquid and Enteral nutritional suspension in people with Crohn Disease and Nutrition Disorders, run by Wei Zhou at 1 site in China.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhou (+8613588706479, zhouweisrrs@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of CRP/ALB level (time frame: 6 weeks). 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 19 Sep 2024.