Crohn DiseaseNCT03755583
Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Gastrointestinal Microbiota for Chinese Children With Crohn's Disease
A study testing Exclusive Enteral Nutrition in people with Crohn Disease and Enteral Nutrition, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Inflammatory bowel diseases (IBD) are chronic inflammatory diseases. It is believed that the inflammation results from sustained abnormal immune response towards altered or pathogenic microbiota in genetically susceptible hosts. Malnutrition is common in IBD, especially in pediatric Crohn's disease(CD). Read more about this study
- Who is it for?
- Ages 1 year to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease, Enteral Nutrition, Gastrointestinal Microbiome
- What is being tested?
- Exclusive Enteral Nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2017to 31 Dec 2019
- 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 1 year to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pediatric CD patients who were newly diagnosed and being treated with EEN at the Children's Hospital of Fudan University
Who cannot join
- (1) patients who were administered corticosteroids, immunosuppressive drugs, or biological agents prior to the study; (2) patients who could not finish the daily prescribed volume of formula for any reason; (3) patients who could not attend consecutive follow-up sessions; (4) patients who had received antibiotics or probiotics within 1.5 months prior to the study; and (5) patients who had been given corticosteroids, immunosuppressive drugs, biological agents, antibiotics, or probiotics during the EEN process.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's hospital of Fudan university
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Intestinal Microbiota for Chinese Children With Crohn's Disease
Inflammatory bowel diseases (IBD) are chronic inflammatory diseases. It is believed that the inflammation results from sustained abnormal immune response towards altered or pathogenic microbiota in genetically susceptible hosts. Malnutrition is common in IBD, especially in pediatric Crohn's disease(CD). Exclusive enteral nutrion(EEN) has been shown to improve nutritional status and inflammatory markers in pediatric CD. But there is limited data about the effect of EEN on Chinese children with CD. In this study, investigators focused on disease process,nutritional status and gut microbiome of Chinese children with newly-diagnosed CD after EEN treatment.
- Being tested
- Exclusive Enteral Nutrition
- Keywords
- Exclusive enteral nutrition
- Medical subject headings
- 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
a complete liquid diet of formula for 8 weeks were adminstered in Crohn's Diseas patients ,Nutritional intake was based on the child's estimated energy requirements, no regular table food during 8 weeks treament.
| Study group | Role | What they receive |
|---|---|---|
| EEN group | Other | Received exclusive enteral nutrition after enrollment. Receives: Dietary Supplement: Exclusive Enteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-item gut microbiota measure
the change of gut microbiota during EEN and after the end of EEN
Measured: 0, 2, 6, 8, 12 weeks post-EEN
2-item Simple Endoscopic Score for CD (SES-CD)
According to the SES-CD, at the end of EEN, the patients whose SES-CD scores were ≤4 were classified into the remission group (CD-RE), other patients whose SES-CD scores were >4 were classified into the non-remission group (CD-NRE)
Measured: 0, 8, weeks post-EEN
Secondary outcomes (7)
5-item weighted Paediatric Crohn's disease activity index measure(wPCDAI)
wPCDAI scoret included 8 items (Abdominal pain, Patient functioning, Stools, ESR, Albumin, Weight, Perirectal disease, Extraintestinal manifestations ).
Measured: 0, 2, 6, 8, 12 weeks post-EEN
2-item 25-hydroxyvitamin D3 measure (25-OH VITD3)
the level of 25-OH VITD3 in 8 weeks post-EEN is higher than 0 week represents a better outcome
Measured: 0,8 weeks post-EEN
5-item weight measure
Measured: 0, 2, 6, 8, 12 weeks post-EEN
5-item height measure
Measured: 0, 2, 6, 8, 12 weeks post-EEN
5-item Fecal Calprotectin
Measured: 0, 2, 6, 8, 12 weeks post-EEN
2-item Insulin-like growth factor-1
Measured: 0, 8 weeks post-EEN
2-item Calcium, vitamin
Measured: 0, 8 weeks post-EEN
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 Feb 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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 Children's Hospital of Fudan UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying HUANG, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755583
- Sponsor's protocol ID
- IBD-EEN-microbiota
- Status last verified
- Jan 2020
- First submitted
- 18 Nov 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Intestinal Microbiota for Chinese Children With Crohn's Disease
- ClinicalTrials.gov ID
- NCT03755583
- Acronym / sponsor ID
- IBD-EEN-microbiota
- Keywords
- Exclusive enteral nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 28 Nov 2018 (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.
Inflammatory bowel diseases (IBD) are chronic inflammatory diseases. It is believed that the inflammation results from sustained abnormal immune response towards altered or pathogenic microbiota in genetically susceptible hosts. Malnutrition is common in IBD, especially in pediatric Crohn's disease(CD). Exclusive enteral nutrion(EEN) has been shown to improve nutritional status and inflammatory markers in pediatric CD. But there is limited data about the effect of EEN on Chinese children with CD. In this study, investigators focused on disease process,nutritional status and gut microbiome of Chinese children with newly-diagnosed CD after EEN treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EEN group | Other | Dietary Supplement: Exclusive Enteral NutritionReceived exclusive enteral nutrition after enrollment. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric CD patients who were newly diagnosed and being treated with EEN at the Children's Hospital of Fudan University
Key exclusion criteria (1 listed)
- (1) patients who were administered corticosteroids, immunosuppressive drugs, or biological agents prior to the study; (2) patients who could not finish the daily prescribed volume of formula for any reason; (3) patients who could not attend consecutive follow-up sessions; (4) patients who had received antibiotics or probiotics within 1.5 months prior to the study; and (5) patients who had been given corticosteroids, immunosuppressive drugs, biological agents, antibiotics, or probiotics during the EEN process.
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 Nutritiona complete liquid diet of formula for 8 weeks were adminstered in Crohn's Diseas patients ,Nutritional intake was based on the child's estimated energy requirements, no regular table food during 8 weeks treament. | Dietary supplement | EEN group |
Primary outcome
5-item gut microbiota measure
Time frame: 0, 2, 6, 8, 12 weeks post-EEN
the change of gut microbiota during EEN and after the end of EEN
2-item Simple Endoscopic Score for CD (SES-CD)
Time frame: 0, 8, weeks post-EEN
According to the SES-CD, at the end of EEN, the patients whose SES-CD scores were ≤4 were classified into the remission group (CD-RE), other patients whose SES-CD scores were >4 were classified into the non-remission group (CD-NRE)
7 secondary outcomes
5-item weighted Paediatric Crohn's disease activity index measure(wPCDAI)
Time frame: 0, 2, 6, 8, 12 weeks post-EEN
2-item 25-hydroxyvitamin D3 measure (25-OH VITD3)
Time frame: 0,8 weeks post-EEN
5-item weight measure
Time frame: 0, 2, 6, 8, 12 weeks post-EEN
5-item height measure
Time frame: 0, 2, 6, 8, 12 weeks post-EEN
5-item Fecal Calprotectin
Time frame: 0, 2, 6, 8, 12 weeks post-EEN
2-item Insulin-like growth factor-1
Time frame: 0, 8 weeks post-EEN
2-item Calcium, vitamin
Time frame: 0, 8 weeks post-EEN
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exclusive Enteral Nutrition in people with Crohn Disease and Enteral Nutrition, run by Children's Hospital of Fudan University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Jan 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-item gut microbiota measure (time frame: 0, 2, 6, 8, 12 weeks post-EEN). The study lists 2 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 27 Jan 2020.