Study of the Determinants of Pediatric Onset Inflammatory Diseases: Host-microbiota-environment Interactions
Study on Gut Health and Early Inflammatory Diseases in Children
Plain English Summary
Host-microbiota-environment Interactions is a Not Applicable clinical trial sponsored by University Hospital, Clermont-Ferrand studying Juvenile Idiopathic Arthritis, Diabetes type1, Inflammatory Bowel Diseases. This study investigates how a child's gut bacteria, environment, and genetics might contribute to the development of certain early-onset inflammatory diseases. It is designed for children recently diagnosed with Juvenile Idiopathic Arthritis (JIA), Inflammatory Bowel Diseases (IBD), or Type 1 Diabetes, and their healthy siblings. Participation involves providing stool samples to analyze gut bacteria, and potentially other samples, with no new treatments being tested. There are no direct alternative treatments being offered within this study; it is observational. The trial aims to enroll 4 participants.
Official Summary
Two types of inflammatory and autoimmune diseases (excluding monogenic diseases) can be distinguished in children: those similar to adult diseases but with an early onset (type 1 diabetes, inflammatory diseases of the gastrointestinal tract, rheumatoid arthritis with anti-CCP antibodies) and those specific to children that are not described in adults (early-onset juvenile idiopathic arthritis with anti-nuclear and anterior uveitis). The familial and nosological aggregations suggest that these diseases are probably polygenically determined, and result from interactions with the environment. In a singular way, the incidence of "adult" diseases is increasing while the age of onset is getting earlier; conversely, there is no increase in early-onset juvenile idiopathic arthritis. On the other hand, the influence of early events that may alter the microbiotic environment is different for different diseases: whereas cesarean section (or early antibiotic therapy) has been shown to increase the risk of JIA and T1DM, it does not seem to change the risk of IBD. We hypothesize that environmental factors, particularly those related to diet and bacterial and fungal digestive microbiota - are different between these disease categories.
Who Can Participate
Here is what you need to know about eligibility for this trial. Children newly diagnosed with JIA, IBD, or Type 1 Diabetes. Healthy brothers or sisters of children with these conditions, who are of a similar age. Children cannot have taken antibiotics in the 4 weeks before providing a stool sample. Children cannot have had a recent digestive infection within 7 days of the sample collection. This trial is studying Juvenile Idiopathic Arthritis, Diabetes type1, Inflammatory Bowel Diseases, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures the types and amounts of bacteria in a child's gut, which helps researchers understand if differences in gut health are linked to these diseases. The specific primary outcome measures are: Gut microbiota composition (Day 1); Gut microbiota composition (12 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it aims to understand the complex interactions that lead to early-onset inflammatory diseases in children, potentially paving the way for new prevention or treatment st This research targets Juvenile Idiopathic Arthritis, Diabetes type1, Inflammatory Bowel Diseases, where improved treatment options are needed.
Investor Insight
While this observational study is terminated and small, understanding the gut microbiome's role in pediatric inflammatory diseases is a growing area of research with significant potential for future t
Is This Trial Right for Me?
Ask your doctor if your child's condition is suitable for this type of observational study. Participation involves providing stool samples for analysis, with no new medications or procedures. The study requires samples to be collected at specific times, which may involve visits to the study site. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 4 participants
Interventions
- OTHER: Stool sample — Comparaison of the gut microbiota composition
Primary Outcomes
- Gut microbiota composition (Day 1)
- Gut microbiota composition (12 months)
Secondary Outcomes
- Composition of the fecal volatolome (Day 1)
- Variation in gut microbiota following initiation of therapy in patients newly diagnosed with JIA, IBD or T1DM. (Day 1, 2 months, 12 months)
- Tryptasemia (Day 1, 2 months, 12 months)
- Fecal contamination with nanoparticles (Day 1)
Full Eligibility Criteria
Inclusion Criteria: CASE: \- Newly diagnosed with JIA, IBD or T1DM CONTROL: \- Brother/sister of child with pediatric onset inflammatory disease (same age category - same environment: diet, living environment) Exclusion Criteria (case and control): * Child with antibiotic treatment in the 4 weeks preceding the stool sample * Recent digestive infectious disease (bacterial, viral, parasitic) (end of episode \< 7 days) Exclusion Criteria (control): children with autoimmune or inflammatory disease
Trial Locations
- CHU de Clermont-Ferrand, Clermont-Ferrand, France
Frequently Asked Questions
What is clinical trial NCT05176795?
NCT05176795 is a Not Applicable OBSERVATIONAL study titled "Host-microbiota-environment Interactions." It is currently terminated and is sponsored by University Hospital, Clermont-Ferrand. The trial targets enrollment of 4 participants.
What conditions does NCT05176795 study?
This trial investigates treatments for Juvenile Idiopathic Arthritis, Diabetes type1, Inflammatory Bowel Diseases. The primary condition under study is Juvenile Idiopathic Arthritis.
What treatments are being tested in NCT05176795?
The interventions being studied include: Stool sample (OTHER). Comparaison of the gut microbiota composition
What does Not Applicable mean for NCT05176795?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05176795?
This trial is currently "Terminated." It started on 2022-03-16. The estimated completion date is 2022-07-12.
Who is sponsoring NCT05176795?
NCT05176795 is sponsored by University Hospital, Clermont-Ferrand. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05176795?
The trial aims to enroll 4 participants. The trial status is terminated.
How is NCT05176795 designed?
This is a observational study.
What are the primary outcomes being measured in NCT05176795?
The primary outcome measures are: Gut microbiota composition (Day 1); Gut microbiota composition (12 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05176795 being conducted?
This trial is being conducted at 1 site, including Clermont-Ferrand (France).
Where can I find official information about NCT05176795?
The official record for NCT05176795 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05176795. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05176795 testing in simple terms?
This study investigates how a child's gut bacteria, environment, and genetics might contribute to the development of certain early-onset inflammatory diseases. It is designed for children recently diagnosed with Juvenile Idiopathic Arthritis (JIA), Inflammatory Bowel Diseases (IBD), or Type 1 Diabetes, and their healthy siblings.
Why is this trial significant?
This trial is important because it aims to understand the complex interactions that lead to early-onset inflammatory diseases in children, potentially paving the way for new prevention or treatment st
What are the potential risks of participating in NCT05176795?
The main risk is the potential discomfort or inconvenience of providing stool samples. There are no new treatments being tested, so risks associated with experimental therapies are not applicable. The study involves analyzing existing biological samples, with minimal direct risk to participants. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05176795?
Ask your doctor if your child's condition is suitable for this type of observational study. Participation involves providing stool samples for analysis, with no new medications or procedures. The study requires samples to be collected at specific times, which may involve visits to the study site. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05176795 signal from an investment perspective?
While this observational study is terminated and small, understanding the gut microbiome's role in pediatric inflammatory diseases is a growing area of research with significant potential for future t This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves providing stool samples to analyze gut bacteria, and potentially other samples, with no new treatments being tested. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Juvenile Idiopathic Arthritis Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.