Impact of a Probiotic Supplement on Gut Microbiota and Glycemic Control in Patients With Type 1 Diabetes Mellitus: A Randomized Double-Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in gut microbiota composition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Probiotic/Prebiotic Supplement (Dietary Supplement)
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.
干预措施: Placebo Gel (Dietary Supplement)
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.
干预措施: Probiotic/Prebiotic Supplement (Dietary Supplement)
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.
干预措施: Placebo Gel (Dietary Supplement)
结局指标
主要结局
Change in gut microbiota composition
时间窗: 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.
次要结局
- 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)
- Change in time above range (>180 mg/dL) [Time Frame: 3 months](Baseline and 98 days post-intervention)
- Change in time below range (<70 mg/dL) [Time Frame: 3 months](Baseline and 98 days post-intervention)
- Change in mean glucose [Time Frame: 3 months](Baseline and 98 days post-intervention)
- Change in glucose variability [Time Frame: 3 months](Baseline and 98 days post-intervention)
- Change in plasma zonulin levels [Time Frame: Day 1 and Day 98](Baseline and 98 days post-intervention)
- Change in fecal calprotectin levels [Time Frame: Day 1 and Day 98](Baseline and 98 days post-intervention)
研究者
Mª Teresa Mercader Ros
Principal Investigator and Academic Secretary of the Bachelor's Degree in Human Nutrition and Dietetics at UCAM
Universidad Católica San Antonio de Murcia