Effect of a Probiotic Supplement on Gut Microbiota and Glycemic Control in Patients With Type 1 Diabetes (PRODIAB)

NCT ID: NCT07062224

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2025-12-31

Brief 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. 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.

Conditions

Diabete Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Type 1 Diabetes - Supplement

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.

Group Type: EXPERIMENTAL

Probiotic/Prebiotic Supplement

Intervention Type: DIETARY_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.

Type 1 Diabetes - Placebo

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.

Group Type: EXPERIMENTAL

Placebo Gel

Intervention Type: DIETARY_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.

Healthy Controls - Supplement

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.

Group Type: EXPERIMENTAL

Probiotic/Prebiotic Supplement

Intervention Type: DIETARY_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.

Healthy Controls - Placebo

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.

Group Type: EXPERIMENTAL

Placebo Gel

Intervention Type: DIETARY_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.

Interventions

Probiotic/Prebiotic 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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo Gel

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Mª Teresa Mercader Ros

Principal Investigator and Academic Secretary of the Bachelor's Degree in Human Nutrition and Dietetics at UCAM

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

María T Mercader Ros, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Católica San Antonio de Murcia

Locations

UCAM San Antonio Catholic University of Murcia

Murcia, Murcia, Spain

Countries

Spain

Central Contacts

María T Mercader Ros, PhD

Role: CONTACT

mtmercader@ucam.edu

+349682785523

Pablo M Barcina Pérez, PhD

Role: CONTACT

pbarcina@ucam.edu

+349682785523

Facility Contacts

San Antonio Catholic University of Murcia UCAM

Role: primary

info@ucam.edu

(+34) 968 27 88 00

References

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.

Reference Type: BACKGROUND

PMID: 38034007 (View on PubMed)

Stewart 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.

Reference Type: BACKGROUND

PMID: 27100052 (View on PubMed)

Other Identifiers

CE122401

Identifier Type: -

Identifier Source: org_study_id