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

NCT06157736 | Recruiting

• 1 other identifier: Acute T1D
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Do the microbiome and metabolome play a role in the onset and presentation of T1D?
2. 2.How do the microbiome and metabolome evolve during the early stages of T1D?
3. 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. 4.Is there an association between the microbiome or metabolome and glycaemic control during the first year of diagnosis?
5. 5.Is there an association between the microbiome or metabolome and beta cell reserve after one year of T1D disease?

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Describe evolution of the microbiome and metabolome during the early stages of new onset T1D

  Microbiome biodiversity in cases vs controls

  52 weeks

Study Arms (2)

Cases

Children with newly diagnosed T1D

Controls

Healthy siblings of cases

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All children aged between 6 months and 18 years who are admitted to hospital with a new diagnosis of T1D will be assessed for eligibility for enrolment to this study. Healthy siblings will be assessed for eligibility to be enrolled as controls in this study

You may qualify if:

• Males and females with newly diagnosed T1D.
• Aged between 6 months and 18 years at their first study visit.
• Consent provided by parent/guardian to participate in this study.
• Age dependent assent or consent obtained for participants aged 6-18 years

You may not qualify if:

• Individuals who have a known diagnosis of inflammatory bowel disease or another medical condition which the study team deems might interfere with the microbiome.
• Individuals with complex medical or behavioural needs that would deem the participant unable to participate in the study.
• 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.
• Participants who are receiving treatment involving experimental medications.
• 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.
• Have a malignant disease or any concomitant end-stage organ disease

Sponsors & Collaborators

• University College Cork: lead
• APC Microbiome Ireland: collaborator

Study Sites (1)

Cork University Hospital

Cork, Ireland

RECRUITING

Related Publications (1)

• Kennedy EC, Ross FC, O'Shea CA, Lavelle A, Ross P, Dempsey E, Stanton C, Hawkes CP. Observational study protocol: the faecal microbiome in the acute stage of new-onset paediatric type 1 diabetes in an Irish cohort. BMJ Open. 2025 Jan 30;15(1):e089206. doi: 10.1136/bmjopen-2024-089206.

  PMID: 39890137 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Stool Urine Blood

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Colin Hawkes

  University College Cork

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colin Hawkes

CONTACT

+353(0)21 4205082; chawkes@ucc.ie

Elaine Kennedy

CONTACT

elainekennedy@ucc.ie

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 6, 2023
• Study Start: October 6, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)