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

Prediabetes

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

Inclusion Criteria3

Hb1AC ranging from 5.7% to 6.4% or
Fasting plasma glucose concentrations ranging from 100 mg/dl to 125 mg/dl or
At Oral Glucose Tolerance Test within 2 hours: blood glucose ranging from 140 mg/dl to 199 mg/dl

Exclusion Criteria14

Short-bowel syndrome patients, with concurrent D-lactic acidosis.
Current hospitalization for any reason.
Co-morbid infection of any kind.
Co-morbid hereditary and/or acquired immune system deficiency.
Patients with genetic defects in insulin action, diseases of the exocrine pancreas, gestational diabetes, endocrinopathies (Cushing’s syndrome, acromegaly, glucagonoma, pheochromocytoma, somatostatinoma, aldestoronoma, hyperthyroidism), drug or chemical- induced diabetes (vacor, pentamidine, nicotinic acid, glucocorticoids, thyroid hormone, diazoxide, b-adrenergic agonists, thiazides, clozapine, protease inhibitors), or Stiffman’s syndrome.
Ingestion of antibiotics < 1 month, prior enrolment and/or intake of yogurts and products containing probiotics or any immune-compromising agent, whatsoever.
Diarrhoea, due to the probiotics administration, that lasts more than 3 days and/or causes severe dehydration, independently of its duration.
Current detection of HBsAg, HBcAb presence and/or established diagnosis of hepatic disorders of any nature.
Inability to commit to clinical trial follow-up.
Atopic dermatitis.
Epilepsy.
Established or possible pregnancy.
Presence of metal prostheses, due to orthopaedic surgery or otherwise or implanted devices such as pacemakers.
Established, chronic life-threatening diseases, such as neoplasias.

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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 Streptococcus thermophilus) daily, orally, for 4 months. Adherence will be monitored according to sachet number return.