Inflammatory Bowel DiseaseETERNITYNCT03264690
Study to Observe the Change in Microbiome in Human Derived Sample and the Relation With Clinical Response Before and After the Anti-TNF Treatment in IBD Patients
An observational study of Inflammatory Bowel Disease, run by Eisai Korea Inc. at 3 sites in South Korea.
Trial summary
This study will be conducted to observe the difference in microbiome composition between healthy participants and inflammatory bowel disease (IBD) participants with no anti-tumor necrosis factor (anti-TNF) treatment. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease
- How many people
- 40 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 21 Sep 2017to 16 Jan 2020
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and female participants diagnosed with inflammatory bowel disease (IBD) will be compared to participants with non-IBD.
- Inclusion/ Exclusion Criteria:
- Inclusion Criteria For Inflammatory Bowel Disease (IBD) participants:
- Male or female, age ≥ 19 years at the time of informed consent
- Confirmed diagnosis of IBD
- Participants who are naïve to anti-tumour necrosis factor (anti-TNF)
- Exclusion Criteria for IBD participants:
- Contraindication to anti-TNF including active tuberculosis (TB), sepsis, or other severe opportunistic infection, etc.
- Inclusion/ Exclusion Criteria:
- Inclusion Criteria for non-IBD participants:
- Participants who have not been diagnosed with IBD
- Participants who don't have any other intestinal disease except IBD
- Participants who are naïve to anti-TNF
- Exclusion Criteria for non-IBD participants:
- Participants who have been on medication to treat underlying disease for the previous 3 months
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Eisai Trial Site # 1
Seoul
Eisai Trial Site # 2
Seoul
Eisai Trial Site # 3
Seoul
About this study
Official title: A Prospective Study to Observe the Change in Microbiome in Human Derived Sample and the Relation With Clinical Response Before and After the Anti-TNF Treatment in IBD Patients
This study will be conducted to observe the difference in microbiome composition between healthy participants and inflammatory bowel disease (IBD) participants with no anti-tumor necrosis factor (anti-TNF) treatment.
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Crohn's disease, Ulcerative colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Microbial composition measured from IBD and non-IBD groups | Participants with inflammatory bowel disease (IBD) and non-IBD will be measured for microbial composition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the composition of the microbiome after anti-tumour necrosis factor (anti-TNF) treatment for inflammatory bowel disease (IBD) at Month 3
Microbiome is the microorganisms in a particular environment (including the body or a part of the body). Changes in the microbiome in fecal, blood, saliva, and urine samples before and after anti-TNF treatment will be assessed.
Measured: Month 3
Secondary outcomes (5)
The difference in the composition of the microbiome at baseline between IBD participants and non-IBD participants
Microbiome is the microorganisms in a particular environment (including the body or a part of the body). Changes in the microbiome in fecal, blood, saliva, and urine samples before and after anti-TNF treatment will be assessed.
Measured: Baseline
Disease activity will be assessed by Crohn's Disease Activity Index (CDAI) or Mayo score for ulcerative colitis (UC)
Disease activity will be assessed by CDAI to quantify the symptoms.
Measured: Up to 3 months
Correlation in the composition of the microbiome at baseline and disease activity will be assessed as measured by CDAI or Mayo score at Month 3
The composition of the microbiome at baseline will be correlated to disease activity which is assessed as measured by CDAI or Mayo score at Month 3.
Measured: Baseline; Month 3
Change from baseline in calprotectin at Month 3
Fecal calprotectin can indicate inflammation in the intestines.
Measured: Baseline; Month 3
Number of participants with abnormal, clinically significant vital signs
Clinical significance will be determined by the investigator.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start21 Sep 2017
- Primary completion16 Jan 2020
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Korea Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264690
- Sponsor's protocol ID
- D2E7-M082-602
- Acronym
- ETERNITY
- Status last verified
- Nov 2019
- First submitted
- 25 Aug 2017
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Observe the Change in Microbiome in Human Derived Sample and the Relation With Clinical Response Before and After the Anti-TNF Treatment in IBD Patients
- ClinicalTrials.gov ID
- NCT03264690
- Acronym / sponsor ID
- ETERNITY / D2E7-M082-602
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Crohn's disease, Ulcerative colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 29 Aug 2017 (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.
This study will be conducted to observe the difference in microbiome composition between healthy participants and inflammatory bowel disease (IBD) participants with no anti-tumor necrosis factor (anti-TNF) treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microbial composition measured from IBD and non-IBD groups | – | –Participants with inflammatory bowel disease (IBD) and non-IBD will be measured for microbial composition. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female participants diagnosed with inflammatory bowel disease (IBD) will be compared to participants with non-IBD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in the composition of the microbiome after anti-tumour necrosis factor (anti-TNF) treatment for inflammatory bowel disease (IBD) at Month 3
Time frame: Month 3
Microbiome is the microorganisms in a particular environment (including the body or a part of the body). Changes in the microbiome in fecal, blood, saliva, and urine samples before and after anti-TNF treatment will be assessed.
5 secondary outcomes
The difference in the composition of the microbiome at baseline between IBD participants and non-IBD participants
Time frame: Baseline
Disease activity will be assessed by Crohn's Disease Activity Index (CDAI) or Mayo score for ulcerative colitis (UC)
Time frame: Up to 3 months
Correlation in the composition of the microbiome at baseline and disease activity will be assessed as measured by CDAI or Mayo score at Month 3
Time frame: Baseline; Month 3
Change from baseline in calprotectin at Month 3
Time frame: Baseline; Month 3
Number of participants with abnormal, clinically significant vital signs
Time frame: Up to 3 months
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 10 Mar 2020.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, run by Eisai Korea Inc. at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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?
Change in the composition of the microbiome after anti-tumour necrosis factor (anti-TNF) treatment for inflammatory bowel disease (IBD) at Month 3 (time frame: Month 3). 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 10 Mar 2020.