Colitis, UlcerativeNCT03841045
Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases
An observational study of Colitis, Ulcerative and Crohn Disease, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
Inflammatory Bowel Diseases (IBDs) are a set of recurrent inflammatory conditions that include the colon and small intestine. The two principal conditions include Crohn's disease (CD) and ulcerative colitis (UC). The etiology of which is likely to stem from the interplay of gut microbial imbalances and host. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colitis, Ulcerative, Crohn Disease
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Sep 2016to Dec 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: people that have UC, CD diagnosis and healthy can participate in the study. the disease can be at any level and the patients can handle any medications. each participant will give fresh stool, saliva and skin samples during the study. only one visit is planned in the study-for sighning ICF and returning samples.
Who may be able to join
- UC
- CD
- healthy Volunteers
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
soroka MC
Beersheba
keren moyal, phd, 972-52-7129531, kerenmo@clalit.org.il
About this study
Inflammatory Bowel Diseases (IBDs) are a set of recurrent inflammatory conditions that include the colon and small intestine. The two principal conditions include Crohn's disease (CD) and ulcerative colitis (UC). The etiology of which is likely to stem from the interplay of gut microbial imbalances and host. In this study stool cultures, saliva and skin samples will be taken from all participants.
Read the detailed description
Recent studies have shown that certain CD patients harbor microbial communities that are distinct from those of healthy individuals. These studies suggest a central role of the gut microbial population in CD. The high complexity of the gut microbiome, which is the most densely populated bacterial niche, makes the identification of these bacteria a significant challenge. The bacterial population is comprised from 1013 - 1014 individuals, all belonging roughly to a thousand different species, mostly anaerobic, and most of them (roughly 70% - 80%) are uncultivable.
The goals of this project are to examine a potential link between bilirubin metabolism and IBD, by comparing fecal extracts from healthy humans and IBD patients, and to investigate the underlying mechanism explaining these differences.
- Conditions
- Colitis, Ulcerative, Crohn Disease
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
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 |
|---|---|---|
| ulcerative colitis patient | people that have UC diagnosis can participate in the study. the disease can be at any level and the patients can handle any medications. | |
| CD patient | people that have CD diagnosis can participate in the study. the disease can be at any label and the patients can handle any medications. | |
| Health people | control group. no IBD patients can be included. patients with other diseases can be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of bilirubin metabolism in fecal samples
liquid chromatography / mass spectrometric (LCMS) analysis is applied to bilirubin metabolism comparison between IBD patients and healthy humans in fecal extracts
Measured: an average of 1 year after recruitment
microbial diversity of fecal matter
16S rRNA sequencing, is used to compare the microbial diversity between healthy individuals and IBD patients
Measured: an average of 1 year after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start14 Sep 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARIK SEGAL MD, Soroka University Medical Center
- Investigators
- ARIK SEGAL, MD, Principal investigator, SOROKA MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841045
- Sponsor's protocol ID
- 0148-15 SOR
- Status last verified
- Feb 2019
- First submitted
- 5 Sep 2018
- Last updated
- 15 Feb 2019
- 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 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT03841045
- Acronym / sponsor ID
- 0148-15 SOR
- Conditions
- Colitis, Ulcerative, Crohn Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- 14 Sep 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Feb 2019 (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 (IBDs) are a set of recurrent inflammatory conditions that include the colon and small intestine. The two principal conditions include Crohn's disease (CD) and ulcerative colitis (UC). The etiology of which is likely to stem from the interplay of gut microbial imbalances and host. In this study stool cultures, saliva and skin samples will be taken from all participants.
Detailed description
Recent studies have shown that certain CD patients harbor microbial communities that are distinct from those of healthy individuals. These studies suggest a central role of the gut microbial population in CD. The high complexity of the gut microbiome, which is the most densely populated bacterial niche, makes the identification of these bacteria a significant challenge. The bacterial population is comprised from 1013 - 1014 individuals, all belonging roughly to a thousand different species, mostly anaerobic, and most of them (roughly 70% - 80%) are uncultivable.
The goals of this project are to examine a potential link between bilirubin metabolism and IBD, by comparing fecal extracts from healthy humans and IBD patients, and to investigate the underlying mechanism explaining these differences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ulcerative colitis patient | – | –people that have UC diagnosis can participate in the study. the disease can be at any level and the patients can handle any medications. |
| CD patient | – | –people that have CD diagnosis can participate in the study. the disease can be at any label and the patients can handle any medications. |
| Health people | – | –control group. no IBD patients can be included. patients with other diseases can be included. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- people that have UC, CD diagnosis and healthy can participate in the study. the disease can be at any level and the patients can handle any medications. each participant will give fresh stool, saliva and skin samples during the study. only one visit is planned in the study-for sighning ICF and returning samples.
Key inclusion criteria (3 listed)
- UC
- CD
- healthy Volunteers
Key exclusion criteria (1 listed)
- N/A
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 of bilirubin metabolism in fecal samples
Time frame: an average of 1 year after recruitment
liquid chromatography / mass spectrometric (LCMS) analysis is applied to bilirubin metabolism comparison between IBD patients and healthy humans in fecal extracts
microbial diversity of fecal matter
Time frame: an average of 1 year after recruitment
16S rRNA sequencing, is used to compare the microbial diversity between healthy individuals and IBD patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- 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. This study is not recruiting at the moment.
ARIK SEGAL, MD principal investigator
SOROKA MC
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 Colitis, Ulcerative and Crohn Disease, run by Soroka University 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 3 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: status not confirmed, as of the sponsor's last update on 15 Feb 2019. 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.
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 ARIK SEGAL, MD (972-50-7413471, ARIKSE@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of bilirubin metabolism in fecal samples (time frame: an average of 1 year after recruitment). 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 15 Feb 2019.