RecruitingPhase 2Phase 3ACTRN12615000470594

Probiotics use impact on metabolic markers, body composition, gut microbiota and immunity markers in prediabetic adolescents.

Evaluating the impact of probiotics use on metabolism body composition, gut microbiota and immunity markers in prediabetic patients. - A randomized, blind, placebo-controlled trial.


Sponsor

Charikleia Stefanaki

Enrollment

50 participants

Start Date

Jun 1, 2015

Study Type

Interventional

Conditions

Summary

The study evaluates the impact of the probiotics' use on the progression of diabetes and the glycemic control of the patients, by examining parameters of the body composition, glycemic control, immunity and gut microbiota.


Eligibility

Sex: Both males and femalesMin Age: 12 YearssMax Age: 20 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether probiotics (beneficial live bacteria) can help prevent or slow the development of type 2 diabetes in teenagers and young adults who currently have pre-diabetes. Researchers will measure blood sugar control, body composition, gut bacteria, and immune markers. You may be eligible if: - You are between 12 and 20 years old - You have been diagnosed with pre-diabetes (elevated but not yet diabetic blood sugar levels) You may NOT be eligible if: - You have short-bowel syndrome with lactic acid build-up - You are currently hospitalised - You have an active infection of any kind - You have an immune system deficiency - You have a hormonal condition that causes diabetes (e.g., Cushing's syndrome) - You have taken antibiotics in the past month or consumed probiotic products regularly - You have epilepsy or atopic dermatitis (eczema) - You are pregnant or may be pregnant - You have metal prostheses or implanted devices such as a pacemaker - You have a serious chronic illness such as cancer Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

2 sachets of VSL#3 (Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, and Stre

2 sachets of VSL#3 (Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, and Streptococcus thermophilus) daily, orally, for 4 months. Adherence will be monitored according to sachet number return.


Locations(1)

Athens, Attiki, Greece

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