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RECRUITINGOBSERVATIONAL

Microbiome in the Acute Stage of New Onset Paediatric Type 1 Diabetes

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The goal of this observational study is to learn more about the microbiome and metabolome of children with type 1 diabetes (T1D). The main questions it aims to answer are: 1. Do the microbiome and metabolome play a role in the onset and presentation of T1D? 2. How do the microbiome and metabolome evolve during the early stages of T1D? 3. Are there are differences in the microbiome or metabolome of children who present with diabetic ketoacidosis (DKA) versus those who present without DKA, and between those who present with mild, moderate or severe DKA? 4. Is there an association between the microbiome or metabolome and glycaemic control during the first year of diagnosis? 5. Is there an association between the microbiome or metabolome and beta cell reserve after one year of T1D disease?

Who May Be Eligible (Plain English)

Who May Qualify: 1. Males and females with newly diagnosed T1D. 2. Aged between 6 months and 18 years at their first study visit. 3. Consent provided by parent/guardian to participate in this study. 4. Age dependent assent or consent obtained for participants aged 6-18 years Who Should NOT Join This Trial: 1. Individuals who have a known diagnosis of inflammatory bowel disease or another medical condition which the study team deems might interfere with the microbiome. 2. Individuals with complex medical or behavioural needs that would deem the participant unable to participate in the study. 3. Have a significant acute or chronic co-existing illness (cardiovascular, gastrointestinal, endocrinological, immunological, metabolic) or any condition which contraindicates entry to the study according to the investigator's judgement. 4. Participants who are receiving treatment involving experimental medications. 5. If the participant took part in a recent experimental trial, the trial must have been completed not less than 30 days prior to participation in this study. 6. Have a malignant disease or any concomitant end-stage organ disease Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Males and females with newly diagnosed T1D. 2. Aged between 6 months and 18 years at their first study visit. 3. Consent provided by parent/guardian to participate in this study. 4. Age dependent assent or consent obtained for participants aged 6-18 years Exclusion Criteria: 1. Individuals who have a known diagnosis of inflammatory bowel disease or another medical condition which the study team deems might interfere with the microbiome. 2. Individuals with complex medical or behavioural needs that would deem the participant unable to participate in the study. 3. Have a significant acute or chronic co-existing illness (cardiovascular, gastrointestinal, endocrinological, immunological, metabolic) or any condition which contraindicates entry to the study according to the investigator's judgement. 4. Participants who are receiving treatment involving experimental medications. 5. If the participant took part in a recent experimental trial, the trial must have been completed not less than 30 days prior to participation in this study. 6. Have a malignant disease or any concomitant end-stage organ disease

Locations (1)

Cork University Hospital
Cork, Ireland