Type 1 DiabetesNCT06157736
Microbiome in the Acute Stage of New Onset Paediatric Type 1 Diabetes
An observational study of Type 1 Diabetes, run by University College Cork at 1 site in Ireland.
Trial 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. Do the microbiome and metabolome play a role in the onset and presentation of T1D? 2. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 6 Oct 2023to 31 Aug 2025
- 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 6 months to 18 years
- All sexes
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Elaine Kennedy contact
Ireland1 site, 1 recruiting
- Recruiting
Cork University Hospital
Cork
Colin Hawkes
About this study
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:
- Do the microbiome and metabolome play a role in the onset and presentation of T1D?
- How do the microbiome and metabolome evolve during the early stages of T1D?
- 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?
- Is there an association between the microbiome or metabolome and glycaemic control during the first year of diagnosis?
- Is there an association between the microbiome or metabolome and beta cell reserve after one year of T1D disease?
Read the detailed description
T1D is caused by autoimmune-mediated destruction of pancreatic beta cells. This leads to a complete deficiency of insulin. Individuals diagnosed with T1D require life-long exogenous insulin replacement to achieve glucose homeostasis and, ultimately, to survive. Although there is an underlying genetic predisposition to developing T1D, the trigger is multifactorial and likely includes environmental factors.
Several large cohort studies have identified differences in the microbiome in those with T1D compared to healthy controls and suggested that it may have a role in the pathogenesis of T1D. It is not yet clear if changes in the microbiome are involved in the pathogenesis of beta-cell destruction or are an effect of the disease state.
When children present with T1D for the first time, their blood glucose levels are elevated. Some children will present with life threatening DKA in which there is metabolic dysfunction and, in some cases, end organ damage.
This study will examine the microbiome and metabolome of children with newly diagnosed T1D during their initial hospital admission, and describe the changes that occur in the microbiome and metabolome as these individuals are commenced on insulin and return to normal glucose homeostasis.
The study will also compare the microbiome and metabolome of children presenting with and without DKA to establish if there are particular patterns of microbial diversity which are more common in one group. The study also aims to establish if there is an association between the microbiome or metabolome and glycaemic control during the first year of T1D diagnosis. The study will also investigate associations between the microbiome and metabolome, and beta cell reserve after the first year of T1D disease.
- Conditions
- Type 1 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
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 |
|---|---|---|
| Cases | Children with newly diagnosed T1D | |
| Controls | Healthy siblings of cases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe evolution of the microbiome and metabolome during the early stages of new onset T1D
Microbiome biodiversity in cases vs controls
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start6 Oct 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- APC Microbiome Ireland
- Responsible party
- Principal investigator, Professor Colin Hawkes, University College Cork
- Investigators
- Colin Hawkes, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157736
- Sponsor's protocol ID
- Acute T1D
- Status last verified
- May 2024
- First submitted
- 27 Nov 2023
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ding M, de Farias FM, O'Connor PM, Huang X, Ross FC, Kennedy EC, Hawkes CP, Hill C, Stanton C, Ross RP. Production of Multiple Variants of the Antimicrobial Sactipeptide Gnavucin D by the Human Gut Isolate Mediterraneibacter gnavus HB038. Microbiologyopen. 2026 Jun;15(3):e70315. doi: 10.1002/mbo3.70315.
PubMed 42178752Kennedy 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.
PubMed 39890137
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome in the Acute Stage of New Onset Paediatric Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06157736
- Acronym / sponsor ID
- Acute T1D
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- APC Microbiome Ireland
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 6 Dec 2023 (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.
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:
- Do the microbiome and metabolome play a role in the onset and presentation of T1D?
- How do the microbiome and metabolome evolve during the early stages of T1D?
- 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?
- Is there an association between the microbiome or metabolome and glycaemic control during the first year of diagnosis?
- Is there an association between the microbiome or metabolome and beta cell reserve after one year of T1D disease?
Detailed description
T1D is caused by autoimmune-mediated destruction of pancreatic beta cells. This leads to a complete deficiency of insulin. Individuals diagnosed with T1D require life-long exogenous insulin replacement to achieve glucose homeostasis and, ultimately, to survive. Although there is an underlying genetic predisposition to developing T1D, the trigger is multifactorial and likely includes environmental factors.
Several large cohort studies have identified differences in the microbiome in those with T1D compared to healthy controls and suggested that it may have a role in the pathogenesis of T1D. It is not yet clear if changes in the microbiome are involved in the pathogenesis of beta-cell destruction or are an effect of the disease state.
When children present with T1D for the first time, their blood glucose levels are elevated. Some children will present with life threatening DKA in which there is metabolic dysfunction and, in some cases, end organ damage.
This study will examine the microbiome and metabolome of children with newly diagnosed T1D during their initial hospital admission, and describe the changes that occur in the microbiome and metabolome as these individuals are commenced on insulin and return to normal glucose homeostasis.
The study will also compare the microbiome and metabolome of children presenting with and without DKA to establish if there are particular patterns of microbial diversity which are more common in one group. The study also aims to establish if there is an association between the microbiome or metabolome and glycaemic control during the first year of T1D diagnosis. The study will also investigate associations between the microbiome and metabolome, and beta cell reserve after the first year of T1D disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Children with newly diagnosed T1D |
| Controls | – | –Healthy siblings of cases |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
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
Describe evolution of the microbiome and metabolome during the early stages of new onset T1D
Time frame: 52 weeks
Microbiome biodiversity in cases vs controls
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Derived from this study: PubMed 42178752Ding M, de Farias FM, O'Connor PM, Huang X, Ross FC, Kennedy EC, Hawkes CP, Hill C, Stanton C, Ross RP. Production of Multiple Variants of the Antimicrobial Sactipeptide Gnavucin D by the Human Gut Isolate Mediterraneibacter gnavus HB038. Microbiologyopen. 2026 Jun;15(3):e70315. doi: 10.1002/mbo3.70315.
- Derived from this study: PubMed 39890137Kennedy 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.
- Individual participant dataSharing planned: No
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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.
Elaine Kennedy contact
Colin Hawkes principal investigator
University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by University College Cork at 1 site in Ireland.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Colin Hawkes (+353(0)21 4205082, chawkes@ucc.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe evolution of the microbiome and metabolome during the early stages of new onset T1D (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06157736, which also lists 2 linked publications.
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 30 May 2024.