Diabete Type 1PRODIABNCT07062224
Effect of a Probiotic Supplement on Gut Microbiota and Glycemic Control in Patients With Type 1 Diabetes (PRODIAB)
A study testing Probiotic/Prebiotic Supplement in people with Diabete Type 1, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
This randomized, double-blind clinical trial aims to evaluate the effect of a probiotic supplement on gut microbiota composition and glycemic control in adults with type 1 diabetes mellitus. A secondary comparison will be made with a healthy control group. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabete Type 1
- What is being tested?
- Probiotic/Prebiotic Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years.
- Ability to understand and sign the informed consent form.
- For the patient group: diagnosis of type 1 diabetes with at least 1 year of disease progression.
- For the control group: healthy individuals without a diagnosis of diabetes or other metabolic disorders.
- No use of antibiotics, probiotics, or prebiotics during the 4 weeks prior to the study start.
- Willingness to comply with the study protocol and attend scheduled visits.
Who cannot join
- Current use of probiotics, prebiotics, or antibiotics.
- Chronic gastrointestinal diseases (e.g., inflammatory bowel disease, irritable bowel syndrome).
- Pregnancy or breastfeeding.
- Participation in another clinical trial within the past 3 months.
- Immunosuppressive diseases, active cancer, or treatment with immunosuppressants.
- Known allergy or intolerance to any component of the supplement or placebo.
- Excessive alcohol or drug use.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
UCAM San Antonio Catholic University of Murcia
Murcia, Murcia, 30107
San Antonio Catholic University of Murcia UCAM, (+34) 968 27 88 00, info@ucam.edu
María T Mercader Ros, PhD
About this study
Official title: Impact of a Probiotic Supplement on Gut Microbiota and Glycemic Control in Patients With Type 1 Diabetes Mellitus: A Randomized Double-Blind Clinical Trial
This randomized, double-blind clinical trial aims to evaluate the effect of a probiotic supplement on gut microbiota composition and glycemic control in adults with type 1 diabetes mellitus. A secondary comparison will be made with a healthy control group. Participants will be assigned to receive either a probiotic or a placebo for 98 days. Stool samples and metabolic parameters will be collected at baseline and after the intervention period. The study seeks to better understand how modulation of the intestinal microbiota may influence glucose regulation in people with type 1 diabetes.
Read the detailed description
This randomized, double-blind clinical trial aims to evaluate the impact of a nutritional supplement composed of inulin (prebiotic) and tyndallized probiotics (paraprobiotics) on gut microbiota composition, intestinal barrier integrity, and glycemic control in individuals with type 1 diabetes mellitus (T1D). A total of 80 participants will be recruited: 40 with T1D and 40 healthy controls. Each group will be randomly assigned to receive either the active supplement or a placebo for a period of approximately 98 days.
The study will include pre- and post-intervention assessments using stool samples (for microbiota analysis and intestinal inflammation markers like zonulin and calprotectin), continuous glucose monitor (CGM) data, blood tests (for glycemic, hepatic, renal, and lipid profiles), body composition analysis by bioimpedance (including phase angle), and validated questionnaires assessing gastrointestinal symptoms, lifestyle, dietary intake, and diabetes-related quality of life.
The main objectives are to analyze changes in gut microbiota diversity and composition, assess effects on intestinal permeability and inflammation, evaluate the safety and tolerability of the supplement, and determine its impact on metabolic markers such as fasting glucose, HbA1c, glycemic variability, and HOMA-IR.
This project seeks to explore microbiota modulation as a potential complementary therapeutic strategy for improving glycemic control and metabolic health in individuals with T1D. The supplement will be provided in 10 mL gel sticks, containing 4000 mg of inulin and 1000 mg of tyndallized probiotics, taken once daily. The intervention period has been strategically planned to avoid holidays and vacation times to ensure adherence and minimize lifestyle variability.
- Conditions
- Diabete Type 1
- Being tested
- Probiotic/Prebiotic Supplement, Placebo Gel
- Keywords
- Gut microbiota, Probiotic supplement, Zonulin, Calprotectin, Type 1 Diabetes, Glycemic Control
- 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.
Probiotic/Prebiotic SupplementDietary supplement
Oral dietary supplement in gel form (10 mL per day) containing 4000 mg of inulin and 1000 mg of tyndallized probiotics. Administered once daily for approximately 98 consecutive days. Produced by Martínez Nieto S.A. (MARNYS®). Intended to modulate gut microbiota and improve glycemic and inflammatory markers.
Placebo GelDietary supplement
Oral placebo in gel form (10 mL per day), identical in appearance, texture, and taste to the active supplement, but without probiotic or prebiotic components. Administered once daily for 98 days to maintain blinding and control effects.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Diabetes - Supplement | Experimental | Participants with type 1 diabetes mellitus will receive a daily 10 mL gel supplement containing 4000 mg of inulin and 1000 mg of tyndallized probiotics for approximately 98 days. The supplement is designed to modulate gut microbiota and improve glycemic control. Receives: Dietary Supplement: Probiotic/Prebiotic Supplement |
| Type 1 Diabetes - Placebo | Experimental | Participants with type 1 diabetes mellitus will receive a daily 10 mL placebo gel without active ingredients for approximately 98 days. The placebo is organoleptically identical to the supplement to maintain blinding. Receives: Dietary Supplement: Placebo Gel |
| Healthy Controls - Supplement | Experimental | Healthy participants will receive a daily 10 mL gel supplement containing 4000 mg of inulin and 1000 mg of tyndallized probiotics for approximately 98 days. This arm allows comparison of microbiota and metabolic responses between diabetic and non-diabetic individuals. Receives: Dietary Supplement: Probiotic/Prebiotic Supplement |
| Healthy Controls - Placebo | Experimental | Healthy participants will receive a daily 10 mL placebo gel without active ingredients for approximately 98 days. The placebo is identical in appearance and flavor to the active supplement. Receives: Dietary Supplement: Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gut microbiota composition
Variation in the relative abundance and diversity of gut microbiota species assessed by 16S rRNA sequencing from stool samples collected at baseline and after 98 days of intervention.
Measured: Baseline and 98 days post-intervention
Secondary outcomes (11)
Change in fasting glucose [Time Frame: Day 1 and Day 98]
Assessment of changes in fasting glucose levels (mg/dL) via blood test.
Measured: Baseline and 98 days post-intervention
Change in HbA1c [Time Frame: Day 1 and Day 98]
Assessment of changes in glycated hemoglobin levels (HbA1c, %) via blood test.
Measured: Baseline and 98 days post-intervention
Change in fasting insulin [Time Frame: Day 1 and Day 98]
Assessment of changes in fasting insulin levels via blood test. μU/mL
Measured: Baseline and 98 days post-intervention
Change in HOMA-IR index [Time Frame: Day 1 and Day 98]
Assessment of changes in insulin resistance estimated using the HOMA-IR index.
Measured: Baseline and 98 days post-intervention
Change in time in range (70-180 mg/dL) [Time Frame: 3 months]
Assessment of the percentage of time that glucose levels are within the target range using continuous glucose monitoring (CGM).
Measured: Baseline and 98 days post-intervention
Change in time above range (>180 mg/dL) [Time Frame: 3 months]
Assessment of the percentage of time with hyperglycemia using CGM.
Measured: Baseline and 98 days post-intervention
Change in time below range (<70 mg/dL) [Time Frame: 3 months]
Assessment of the percentage of time with hypoglycemia using CGM.
Measured: Baseline and 98 days post-intervention
Change in mean glucose [Time Frame: 3 months]
Assessment of average glucose concentration (mg/dL) using CGM.
Measured: Baseline and 98 days post-intervention
Change in glucose variability [Time Frame: 3 months]
Assessment of glucose coefficient of variation (%) using CGM.
Measured: Baseline and 98 days post-intervention
Change in plasma zonulin levels [Time Frame: Day 1 and Day 98]
Zonulin levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (ng/mL).
Measured: Baseline and 98 days post-intervention
Change in fecal calprotectin levels [Time Frame: Day 1 and Day 98]
Calprotectin levels will be measured in stool samples using immunoassay at baseline and after the intervention (µg/g).
Measured: Baseline and 98 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study startSep 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 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 Diabete Type 1Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is a 2x2 factorial, randomized, double-blind clinical trial including adults with type 1 diabetes and healthy controls. Participants in both groups will be randomly assigned to receive either a probiotic/prebiotic supplement or a placebo. The intervention period will last approximately 98 days. The design allows for the evaluation of the independent and combined effects of participant type (T1D vs. healthy) and intervention (supplement vs. placebo).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mª Teresa Mercader Ros, Universidad Católica San Antonio de Murcia
- Investigators
- María T Mercader Ros, PhD, Principal investigator, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062224
- Sponsor's protocol ID
- CE122401
- Acronym
- PRODIAB
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Abuqwider J, Corrado A, Scida G, Lupoli R, Costabile G, Mauriello G, Bozzetto L. Gut microbiome and blood glucose control in type 1 diabetes: a systematic review. Front Endocrinol (Lausanne). 2023 Nov 15;14:1265696. doi: 10.3389/fendo.2023.1265696. eCollection 2023.
PubMed 38034007Stewart CJ, Nelson A, Campbell MD, Walker M, Stevenson EJ, Shaw JA, Cummings SP, West DJ. Gut microbiota of Type 1 diabetes patients with good glycaemic control and high physical fitness is similar to people without diabetes: an observational study. Diabet Med. 2017 Jan;34(1):127-134. doi: 10.1111/dme.13140. Epub 2016 May 14.
PubMed 27100052
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Probiotic Supplement on Gut Microbiota and Glycemic Control in Patients With Type 1 Diabetes Mellitus: A Randomized Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT07062224
- Acronym / sponsor ID
- PRODIAB / CE122401
- Conditions
- Diabete Type 1
- Keywords
- Gut microbiota, Probiotic supplement, Zonulin, Calprotectin, Type 1 Diabetes, Glycemic Control
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Jul 2025 (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.
This randomized, double-blind clinical trial aims to evaluate the effect of a probiotic supplement on gut microbiota composition and glycemic control in adults with type 1 diabetes mellitus. A secondary comparison will be made with a healthy control group. Participants will be assigned to receive either a probiotic or a placebo for 98 days. Stool samples and metabolic parameters will be collected at baseline and after the intervention period. The study seeks to better understand how modulation of the intestinal microbiota may influence glucose regulation in people with type 1 diabetes.
Detailed description
This randomized, double-blind clinical trial aims to evaluate the impact of a nutritional supplement composed of inulin (prebiotic) and tyndallized probiotics (paraprobiotics) on gut microbiota composition, intestinal barrier integrity, and glycemic control in individuals with type 1 diabetes mellitus (T1D). A total of 80 participants will be recruited: 40 with T1D and 40 healthy controls. Each group will be randomly assigned to receive either the active supplement or a placebo for a period of approximately 98 days.
The study will include pre- and post-intervention assessments using stool samples (for microbiota analysis and intestinal inflammation markers like zonulin and calprotectin), continuous glucose monitor (CGM) data, blood tests (for glycemic, hepatic, renal, and lipid profiles), body composition analysis by bioimpedance (including phase angle), and validated questionnaires assessing gastrointestinal symptoms, lifestyle, dietary intake, and diabetes-related quality of life.
The main objectives are to analyze changes in gut microbiota diversity and composition, assess effects on intestinal permeability and inflammation, evaluate the safety and tolerability of the supplement, and determine its impact on metabolic markers such as fasting glucose, HbA1c, glycemic variability, and HOMA-IR.
This project seeks to explore microbiota modulation as a potential complementary therapeutic strategy for improving glycemic control and metabolic health in individuals with T1D. The supplement will be provided in 10 mL gel sticks, containing 4000 mg of inulin and 1000 mg of tyndallized probiotics, taken once daily. The intervention period has been strategically planned to avoid holidays and vacation times to ensure adherence and minimize lifestyle variability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a 2x2 factorial, randomized, double-blind clinical trial including adults with type 1 diabetes and healthy controls. Participants in both groups will be randomly assigned to receive either a probiotic/prebiotic supplement or a placebo. The intervention period will last approximately 98 days. The design allows for the evaluation of the independent and combined effects of participant type (T1D vs. healthy) and intervention (supplement vs. placebo).
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes - Supplement | Experimental | Dietary Supplement: Probiotic/Prebiotic SupplementParticipants with type 1 diabetes mellitus will receive a daily 10 mL gel supplement containing 4000 mg of inulin and 1000 mg of tyndallized probiotics for approximately 98 days. The supplement is designed to modulate gut microbiota and improve glycemic control. |
| Type 1 Diabetes - Placebo | Experimental | Dietary Supplement: Placebo GelParticipants with type 1 diabetes mellitus will receive a daily 10 mL placebo gel without active ingredients for approximately 98 days. The placebo is organoleptically identical to the supplement to maintain blinding. |
| Healthy Controls - Supplement | Experimental | Dietary Supplement: Probiotic/Prebiotic SupplementHealthy participants will receive a daily 10 mL gel supplement containing 4000 mg of inulin and 1000 mg of tyndallized probiotics for approximately 98 days. This arm allows comparison of microbiota and metabolic responses between diabetic and non-diabetic individuals. |
| Healthy Controls - Placebo | Experimental | Dietary Supplement: Placebo GelHealthy participants will receive a daily 10 mL placebo gel without active ingredients for approximately 98 days. The placebo is identical in appearance and flavor to the active supplement. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 65 years.
- Ability to understand and sign the informed consent form.
- For the patient group: diagnosis of type 1 diabetes with at least 1 year of disease progression.
- For the control group: healthy individuals without a diagnosis of diabetes or other metabolic disorders.
- No use of antibiotics, probiotics, or prebiotics during the 4 weeks prior to the study start.
Key exclusion criteria (7 listed)
- Current use of probiotics, prebiotics, or antibiotics.
- Chronic gastrointestinal diseases (e.g., inflammatory bowel disease, irritable bowel syndrome).
- Pregnancy or breastfeeding.
- Participation in another clinical trial within the past 3 months.
- Immunosuppressive diseases, active cancer, or treatment with immunosuppressants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic/Prebiotic SupplementOral dietary supplement in gel form (10 mL per day) containing 4000 mg of inulin and 1000 mg of tyndallized probiotics. Administered once daily for approximately 98 consecutive days. Produced by Martínez Nieto S.A. (MARNYS®). Intended to modulate gut microbiota and improve glycemic and inflammatory markers. | Dietary supplement | Healthy Controls - Supplement, Type 1 Diabetes - Supplement |
| Placebo GelOral placebo in gel form (10 mL per day), identical in appearance, texture, and taste to the active supplement, but without probiotic or prebiotic components. Administered once daily for 98 days to maintain blinding and control effects. | Dietary supplement | Healthy Controls - Placebo, Type 1 Diabetes - Placebo |
Primary outcome
Change in gut microbiota composition
Time frame: Baseline and 98 days post-intervention
Variation in the relative abundance and diversity of gut microbiota species assessed by 16S rRNA sequencing from stool samples collected at baseline and after 98 days of intervention.
11 secondary outcomes
Change in fasting glucose [Time Frame: Day 1 and Day 98]
Time frame: Baseline and 98 days post-intervention
Change in HbA1c [Time Frame: Day 1 and Day 98]
Time frame: Baseline and 98 days post-intervention
Change in fasting insulin [Time Frame: Day 1 and Day 98]
Time frame: Baseline and 98 days post-intervention
Change in HOMA-IR index [Time Frame: Day 1 and Day 98]
Time frame: Baseline and 98 days post-intervention
Change in time in range (70-180 mg/dL) [Time Frame: 3 months]
Time frame: Baseline and 98 days post-intervention
Change in time above range (>180 mg/dL) [Time Frame: 3 months]
Time frame: Baseline and 98 days post-intervention
Change in time below range (<70 mg/dL) [Time Frame: 3 months]
Time frame: Baseline and 98 days post-intervention
Change in mean glucose [Time Frame: 3 months]
Time frame: Baseline and 98 days post-intervention
Change in glucose variability [Time Frame: 3 months]
Time frame: Baseline and 98 days post-intervention
Change in plasma zonulin levels [Time Frame: Day 1 and Day 98]
Time frame: Baseline and 98 days post-intervention
Change in fecal calprotectin levels [Time Frame: Day 1 and Day 98]
Time frame: Baseline and 98 days post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Background: PubMed 38034007Abuqwider J, Corrado A, Scida G, Lupoli R, Costabile G, Mauriello G, Bozzetto L. Gut microbiome and blood glucose control in type 1 diabetes: a systematic review. Front Endocrinol (Lausanne). 2023 Nov 15;14:1265696. doi: 10.3389/fendo.2023.1265696. eCollection 2023.
- Background: PubMed 27100052Stewart CJ, Nelson A, Campbell MD, Walker M, Stevenson EJ, Shaw JA, Cummings SP, West DJ. Gut microbiota of Type 1 diabetes patients with good glycaemic control and high physical fitness is similar to people without diabetes: an observational study. Diabet Med. 2017 Jan;34(1):127-134. doi: 10.1111/dme.13140. Epub 2016 May 14.
- Individual participant dataSharing planned: Yes
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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.
María T Mercader Ros, PhD principal investigator
Universidad Católica San Antonio de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic/Prebiotic Supplement in people with Diabete Type 1, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 14 Jul 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María T Mercader Ros, PhD (+349682785523, mtmercader@ucam.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gut microbiota composition (time frame: Baseline and 98 days post-intervention). 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 NCT07062224, 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 14 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.