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

Официальное название

Impact of a Probiotic Supplement on Gut Microbiota and Glycemic Control in Patients With Type 1 Diabetes Mellitus: A Randomized Double-Blind Clinical Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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.
• Пищевая добавка 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.

Первичные конечные точки

• Change in gut microbiota composition [Срок оценки: Baseline and 98 days post-intervention]

Вторичные конечные точки (11)

• Change in fasting glucose [Time Frame: Day 1 and Day 98] [Срок оценки: Baseline and 98 days post-intervention]
• Change in HbA1c [Time Frame: Day 1 and Day 98] [Срок оценки: Baseline and 98 days post-intervention]
• Change in fasting insulin [Time Frame: Day 1 and Day 98] [Срок оценки: Baseline and 98 days post-intervention]
• Change in HOMA-IR index [Time Frame: Day 1 and Day 98] [Срок оценки: Baseline and 98 days post-intervention]
• Change in time in range (70-180 mg/dL) [Time Frame: 3 months] [Срок оценки: Baseline and 98 days post-intervention]
• Change in time above range (>180 mg/dL) [Time Frame: 3 months] [Срок оценки: Baseline and 98 days post-intervention]
• Change in time below range (<70 mg/dL) [Time Frame: 3 months] [Срок оценки: Baseline and 98 days post-intervention]
• Change in mean glucose [Time Frame: 3 months] [Срок оценки: Baseline and 98 days post-intervention]
• Change in glucose variability [Time Frame: 3 months] [Срок оценки: Baseline and 98 days post-intervention]
• Change in plasma zonulin levels [Time Frame: Day 1 and Day 98] [Срок оценки: Baseline and 98 days post-intervention]
• Change in fecal calprotectin levels [Time Frame: Day 1 and Day 98] [Срок оценки: Baseline and 98 days post-intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• UCAM San Antonio Catholic University of Murcia — Murcia

Публикации

• 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
• 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

Идентификаторы

NCT: NCT07062224 · CE122401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗