Crohn DiseaseNCT04915911
Nutritional Status and Body Composition of Adult Patients With Crohn's Disease
An observational study of Crohn Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Patients with Crohn's disease generally have nutritional risks and malnutrition. The investigators will conduct a multicenter cross-sectional study to discover nutritional status and body composition of Chinese adult patients with CD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- cross-sectional study
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 1 May 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese adult patients with Crohn's Disease
Who may be able to join
- Age ≥ 18 years old;
- diagnosis of CD;
- Admission time <48 hours;
- Subject has voluntarily signed and dated an informed consent form.
Who cannot join
- Emergency surgery for intestinal fistula or abdominal abscess;
- Unstable vital signs or unstable hemodynamics;
- Pregnant or lactating women;
- Admission to hospital due to other critical illnesses (such as tumor, HIV, severe infections requiring ventilator or CRRT treatment);
- Dying patients whose life expectancy does not exceed 24 hours;
- Severe liver insufficiency (liver function score 11-15 or total bilirubin> 3mg/dL or tissue biopsy diagnosed as liver cirrhosis, hepatic encephalopathy, portal hypertension with history of gastrointestinal hemorrhage, etc.);
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- Severe renal insufficiency (creatinine value is 2 times higher than the upper limit of normal);
- Severe metabolic diseases (such as metabolic syndrome, hyperthyroidism, etc.);
- Patients whose burn area exceeds 20% of the body surface area;
- Immunodeficiency, autoimmune disease, or receiving immunosuppressive treatment for diseases other than CD (such as organ transplantation, etc.);
- Those who are not suitable for body composition analysis
- Patients who have been selected for other clinical studies or have been selected for this study;
- Subjects are unwilling to participate in this study or refuse to sign informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Pianhong Zhang, Ms, +86 87783852, zrlcyyzx@zju.edu.cn
About this study
Official title: A Multi-center, Cross-sectional Observational Study on Nutritional Status and Body Composition of Adult Patients With Crohn's Disease
Patients with Crohn's disease generally have nutritional risks and malnutrition. The investigators will conduct a multicenter cross-sectional study to discover nutritional status and body composition of Chinese adult patients with CD.
Read the detailed description
Several studies have found that the body composition of CD patients is related to disease and therapies. Due to lack of a prospective multicenter cross-sectional observational study on the nutritional status and body composition of adult patients with CD in China. Evaluating the nutritional status and body composition of these patients can help formulate individualized nutritional support strategies for adult CD patients.
- Conditions
- Crohn Disease
- Being tested
- cross-sectional study
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross-sectional studyOther
cross-sectional study
| Study group | Role | What they receive |
|---|---|---|
| adult patients with Crohn's disease | multi-center cross-sectional study Receives: Other: cross-sectional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appendicular skeletal mass index
Bioelectrical impedance analysis
Measured: Within 48 hours of admission to hospital
Secondary outcomes (4)
Body composition
Especially body fat mass by bioelectrical impedance analysis
Measured: Within 48 hours of admission to hospital
Nutritional risk screening
Detect the presence of undernutrition and the risk of developing undernutrition by Risk Screening 2002 (NRS-2002), when score≥3, the patient is nutritionally at-risk
Measured: Within 48 hours of admission to hospital
Nutritional assessment
Detect malnourished individuals by the Subjective Global Assessment (SGA) , where A is well nourished and C is severely malnourished
Measured: Within 48 hours of admission to hospital
Grip strength
Hand grip strength test
Measured: Within 48 hours of admission to hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Jul 2021
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2023 (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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915911
- Sponsor's protocol ID
- 2020-1109
- Status last verified
- Apr 2021
- First submitted
- 11 Apr 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Cross-sectional Observational Study on Nutritional Status and Body Composition of Adult Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT04915911
- Acronym / sponsor ID
- 2020-1109
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 7 Jun 2021 (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.
Patients with Crohn's disease generally have nutritional risks and malnutrition. The investigators will conduct a multicenter cross-sectional study to discover nutritional status and body composition of Chinese adult patients with CD.
Detailed description
Several studies have found that the body composition of CD patients is related to disease and therapies. Due to lack of a prospective multicenter cross-sectional observational study on the nutritional status and body composition of adult patients with CD in China. Evaluating the nutritional status and body composition of these patients can help formulate individualized nutritional support strategies for adult CD patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients with Crohn's disease | – | Other: cross-sectional studymulti-center cross-sectional study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese adult patients with Crohn's Disease
Key inclusion criteria (4 listed)
- Age ≥ 18 years old;
- diagnosis of CD;
- Admission time <48 hours;
- Subject has voluntarily signed and dated an informed consent form.
Key exclusion criteria (13 listed)
- Emergency surgery for intestinal fistula or abdominal abscess;
- Unstable vital signs or unstable hemodynamics;
- Pregnant or lactating women;
- Admission to hospital due to other critical illnesses (such as tumor, HIV, severe infections requiring ventilator or CRRT treatment);
- Dying patients whose life expectancy does not exceed 24 hours;
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 |
|---|---|---|
| cross-sectional studycross-sectional study | Other | adult patients with Crohn's disease |
Primary outcome
Appendicular skeletal mass index
Time frame: Within 48 hours of admission to hospital
Bioelectrical impedance analysis
4 secondary outcomes
Body composition
Time frame: Within 48 hours of admission to hospital
Nutritional risk screening
Time frame: Within 48 hours of admission to hospital
Nutritional assessment
Time frame: Within 48 hours of admission to hospital
Grip strength
Time frame: Within 48 hours of admission to hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 4 inclusion and 13 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 15 Jul 2021. 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. 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 Pianhong Zhang, MS (+86 8778 3852, zrlcyyzx@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appendicular skeletal mass index (time frame: Within 48 hours of admission to hospital). 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 15 Jul 2021.