Exploring the microbiome in children with new onset Type 1 Diabetes

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

This study is trying to see how the bacteria in the gut and other biological factors in children newly diagnosed with Type 1 Diabetes might affect their health and how severe their condition is.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 6 Months to 18 Years
• Sex: All
• Sponsor: University College Cork (Academic / other)
• Locations: 1 site (Cork)
• Trial ID: NCT06157736 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the role of the microbiome and metabolome in children newly diagnosed with Type 1 Diabetes (T1D). It will assess how these biological factors evolve during the early stages of T1D and their potential association with diabetic ketoacidosis (DKA) severity and glycaemic control. By comparing the microbiome and metabolome of children presenting with and without DKA, the study seeks to identify specific microbial patterns that may influence disease progression. The research will be conducted during the initial hospital admission of participants, providing insights into the relationship between these factors and the management of T1D.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 months to 18 years who have recently been diagnosed with Type 1 Diabetes.

Not a fit: Patients with known inflammatory bowel disease or other significant medical conditions that may interfere with the microbiome will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding of the microbiome's role in Type 1 Diabetes, potentially guiding future therapeutic strategies.

How similar studies have performed: Previous studies have indicated differences in the microbiome of individuals with Type 1 Diabetes compared to healthy controls, suggesting a potential link that this study aims to explore further.

Eligibility criteria

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

Where this trial is running

Cork

• Cork University Hospital — Cork, Ireland (Recruiting)

Study contacts

• Principal investigator: Colin Hawkes — University College Cork
• Study coordinator: Colin Hawkes

Conditions Type 1 Diabetes