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

NCT07062224 | Not Yet Recruiting

• 1 other identifier: CE122401
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabete Type 1

Keywords

Gut microbiota; Probiotic supplement; Zonulin; Calprotectin; Type 1 Diabetes; Glycemic Control

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 98 days post-intervention

Secondary Outcomes (11)

• Change in fasting glucose [Time Frame: Day 1 and Day 98]

  Baseline and 98 days post-intervention

• Change in HbA1c [Time Frame: Day 1 and Day 98]

  Baseline and 98 days post-intervention

• Change in fasting insulin [Time Frame: Day 1 and Day 98]

  Baseline and 98 days post-intervention

• Change in HOMA-IR index [Time Frame: Day 1 and Day 98]

  Baseline and 98 days post-intervention

• Change in time in range (70-180 mg/dL) [Time Frame: 3 months]

  Baseline and 98 days post-intervention

Study Arms (4)

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.

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.

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.

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.

Dietary Supplement: Placebo Gel

Interventions

Probiotic/Prebiotic Supplement 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 - Supplement; Type 1 Diabetes - Supplement

Placebo Gel 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 - Placebo; Type 1 Diabetes - Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

UCAM San Antonio Catholic University of Murcia

Murcia, Murcia, 30107, Spain

Location

Related Publications (2)

• 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.

  PMID: 38034007 BACKGROUND

• 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.

  PMID: 27100052 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• María T Mercader Ros, PhD

  Universidad Católica San Antonio de Murcia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María T Mercader Ros, PhD

CONTACT

+349682785523; mtmercader@ucam.edu

Pablo M Barcina Pérez, PhD

CONTACT

+349682785523; pbarcina@ucam.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study. Participants, investigators, care providers, and outcomes assessors are unaware of the group assignments. The probiotic and placebo supplements are identical in appearance and packaging, and group codes will remain confidential until after data analysis is complete.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Academic Secretary of the Bachelor's Degree in Human Nutrition and Dietetics at UCAM

Model Details: 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).

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 14, 2025
• Study Start: September 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)