Inflammatory Bowel DiseaseNCT05652491
The Role of Gut Microbiome in Predicting Comorbidities and Complications in Children With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease and Crohn's Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
Background: Bacteria and other microorganisms that live in the intestines (the gut microbiome) play an important role in a person s health. The gut microbiome helps to regulate the immune system and control inflammation. Read more about this study
- Who is it for?
- Ages Up to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Dec 2022to 30 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 Up to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients already planned to have a colonoscopy as per their primary gastroenterologist seen at Pediatric Specialists of Virginia
Who may be able to join
- Patients 0<=21 years of age undergoing colonoscopy will be approached for enrollment in this study.
Who cannot join
- Participants carrying known diagnosis of IBD, including Crohn's disease, Ulcerative Colitis or IBD-Unspecified. However, patients with IBD suspected prior to colonoscopy can be included.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
Inova Fairfax Medical Campus
Falls Church, Virginia, 22066
About this study
Background:
Bacteria and other microorganisms that live in the intestines (the gut microbiome) play an important role in a person s health. The gut microbiome helps to regulate the immune system and control inflammation. Imbalances in the gut microbiome have been linked to illnesses such as inflammatory bowel disease (IBD). People diagnosed with IBD can have serious health problems. Researchers want to know more about how the gut microbiome affects the development and progression of IBD in children. In this natural history study, they will compare the gut microbiomes of healthy children with those who have IBD.
Read more
Objective:
To collect stool and samples of intestine tissue from children with and without IBD undergoing colonoscopy.
Eligibility:
People under 21 years old who are having a colonoscopy at the Inova Health System or Pediatric Specialists of Virginia.
Design:
Participants will fill out a questionnaire. They will answer questions about their history. Topics may include how they were fed as infants; how they were born; and how often they took antibiotics.
Stool and tissue samples from the intestines will be taken during the participants colonoscopy. They may also give samples of blood and urine.
Participants may be asked to provide additional stool, blood, and urine samples. They may do this up to 3 times per year. These samples may be collected at the clinic; they may also be collected at home and mailed to the researchers.
If they have more colonoscopies, participants may be asked for more tissue samples.
Participants will be enrolled for up to 10 years.
...
Read the detailed description
The gut microbiome (community of microorganisms in the intestines) serves many important roles in healthy people, including immune system regulation and anti-inflammatory functions. A dysbiosis (imbalance) in the gut microbiome is associated with many immune mediated diseases, including inflammatory bowel disease (IBD). The microbiome is thought to play a central role in the development and propagation in IBD. Studies have shown that in IBD, the gut microbiome demonstrates increased pro-inflammatory bacteria, a reduction in anti-inflammatory bacteria and overall reduced diversity. Inflammatory bowel disease is complicated and comes at a high burden to those affected. While affecting both children and adults, patients diagnosed before 18 years of age often have more severe phenotypes than those diagnosed in adulthood. Patients affected by IBD often have many complications such as linear growth failure, decreased bone mineral indices, delayed puberty, malnutrition and need for surgeries. At this time, we have limited ability to predict which patients will go on to develop complications and the time points in which these may occur.
Further, there are many comorbidities present in patients with IBD including dermatologic manifestations, hepatobiliary disease, other immune-mediated disease such as celiac disease as well as endocrinopathies. Children with IBD and these comorbid conditions are thought to have higher morbidity and decreased quality of life. While the gut microbiome is thought to mediate the development of many of these diseases, there is little literature associating clinical and microbiome drivers of those with IBD and these additional comorbidities.
Given that the microbiome may have a role in potentiating the inflammatory pathways contributing to IBD, there is potential to identify microbial signatures to help determine disease outcomes such as complications and response to treatment. In this study, we intend to examine differences in the microbiome diversity and composition in children with IBD and controls. We will then follow subjects longitudinally to determine initial microbiota signatures and changes for those who develop comorbidities, complications and therapy responsiveness.
We hope that by elucidating the microbiome of these children, we will have the opportunity to better understand the pathogeneses of co-morbid diseases, ultimately enabling the development of microbiome-based therapeutics for these conditions.
- Keywords
- Pediatrics, Crohn's Disease, Ulcerative Colitis, Microbiota, Host-Microbiome Response, Natural History
- 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 |
|---|---|---|
| Control | Subjects who are not diagnosed with IBD | |
| IBD Patients | New onset, treatment-naive pediatric IBD patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
differences in fecal/intestinal microbiome
Determine differences in fecal/intestinal microbiome of patients IBD as compared to controls
Measured: at diagnosis
differences in fecal microbiome diversity and composition
Determine differences in fecal microbiome diversity and composition in children with IBD with and without comorbidities
Measured: longitudinal throughout follow up
microbiome signatures for newly diagnosed IBD patients
Determine if microbiome signatures for newly diagnosed IBD patients can predict complications and response to treatments
Measured: longitudinal throughout follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start9 Dec 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Why it stopped: NIH Intramural Program is not the Responsible Party for this study and thus not responsible for registration.
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.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Suchitra K Hourigan, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652491
- Sponsor's protocol ID
- 10000909
- Other IDs
- 000909-I
- Status last verified
- May 2023
- First submitted
- 13 Dec 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: .Raw, de-identified data may be shared as part of publication. This will only be sequencing data, any other data will be compiled.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Gut Microbiome in Predicting Comorbidities and Complications in Children With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05652491
- Acronym / sponsor ID
- 10000909
- Keywords
- Pediatrics, Crohn's Disease, Ulcerative Colitis, Microbiota, Host-Microbiome Response, Natural History
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: NIH Intramural Program is not the Responsible Party for this study and thus not responsible for registration.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 15 Dec 2022 (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.
Background:
Bacteria and other microorganisms that live in the intestines (the gut microbiome) play an important role in a person s health. The gut microbiome helps to regulate the immune system and control inflammation. Imbalances in the gut microbiome have been linked to illnesses such as inflammatory bowel disease (IBD). People diagnosed with IBD can have serious health problems. Researchers want to know more about how the gut microbiome affects the development and progression of IBD in children. In this natural history study, they will compare the gut microbiomes of healthy children with those who have IBD.
Objective:
To collect stool and samples of intestine tissue from children with and without IBD undergoing colonoscopy.
Eligibility:
People under 21 years old who are having a colonoscopy at the Inova Health System or Pediatric Specialists of Virginia.
Design:
Participants will fill out a questionnaire. They will answer questions about their history. Topics may include how they were fed as infants; how they were born; and how often they took antibiotics.
Stool and tissue samples from the intestines will be taken during the participants colonoscopy. They may also give samples of blood and urine.
Participants may be asked to provide additional stool, blood, and urine samples. They may do this up to 3 times per year. These samples may be collected at the clinic; they may also be collected at home and mailed to the researchers.
If they have more colonoscopies, participants may be asked for more tissue samples.
Participants will be enrolled for up to 10 years.
...
Detailed description
The gut microbiome (community of microorganisms in the intestines) serves many important roles in healthy people, including immune system regulation and anti-inflammatory functions. A dysbiosis (imbalance) in the gut microbiome is associated with many immune mediated diseases, including inflammatory bowel disease (IBD). The microbiome is thought to play a central role in the development and propagation in IBD. Studies have shown that in IBD, the gut microbiome demonstrates increased pro-inflammatory bacteria, a reduction in anti-inflammatory bacteria and overall reduced diversity. Inflammatory bowel disease is complicated and comes at a high burden to those affected. While affecting both children and adults, patients diagnosed before 18 years of age often have more severe phenotypes than those diagnosed in adulthood. Patients affected by IBD often have many complications such as linear growth failure, decreased bone mineral indices, delayed puberty, malnutrition and need for surgeries. At this time, we have limited ability to predict which patients will go on to develop complications and the time points in which these may occur.
Further, there are many comorbidities present in patients with IBD including dermatologic manifestations, hepatobiliary disease, other immune-mediated disease such as celiac disease as well as endocrinopathies. Children with IBD and these comorbid conditions are thought to have higher morbidity and decreased quality of life. While the gut microbiome is thought to mediate the development of many of these diseases, there is little literature associating clinical and microbiome drivers of those with IBD and these additional comorbidities.
Given that the microbiome may have a role in potentiating the inflammatory pathways contributing to IBD, there is potential to identify microbial signatures to help determine disease outcomes such as complications and response to treatment. In this study, we intend to examine differences in the microbiome diversity and composition in children with IBD and controls. We will then follow subjects longitudinally to determine initial microbiota signatures and changes for those who develop comorbidities, complications and therapy responsiveness.
We hope that by elucidating the microbiome of these children, we will have the opportunity to better understand the pathogeneses of co-morbid diseases, ultimately enabling the development of microbiome-based therapeutics for these conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Subjects who are not diagnosed with IBD |
| IBD Patients | – | –New onset, treatment-naive pediatric IBD patients |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients already planned to have a colonoscopy as per their primary gastroenterologist seen at Pediatric Specialists of Virginia
Key inclusion criteria (1 listed)
- Patients 0<=21 years of age undergoing colonoscopy will be approached for enrollment in this study.
Key exclusion criteria (1 listed)
- Participants carrying known diagnosis of IBD, including Crohn's disease, Ulcerative Colitis or IBD-Unspecified. However, patients with IBD suspected prior to colonoscopy can be included.
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
differences in fecal/intestinal microbiome
Time frame: at diagnosis
Determine differences in fecal/intestinal microbiome of patients IBD as compared to controls
differences in fecal microbiome diversity and composition
Time frame: longitudinal throughout follow up
Determine differences in fecal microbiome diversity and composition in children with IBD with and without comorbidities
microbiome signatures for newly diagnosed IBD patients
Time frame: longitudinal throughout follow up
Determine if microbiome signatures for newly diagnosed IBD patients can predict complications and response to treatments
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: Yes. .Raw, de-identified data may be shared as part of publication. This will only be sequencing data, any other data will be compiled.
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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.
Suchitra K Hourigan, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
2 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 and Crohn's Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
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: withdrawn, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
differences in fecal/intestinal microbiome (time frame: at diagnosis). The study lists 3 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 1 Jun 2023.