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

Phase 2

Recruiting

• Conditions: Prediabetes; Metabolic and Endocrine - Diabetes; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function; Inflammatory and Immune System - Autoimmune diseases

• Registration Number: ACTRN12615000470594
• Lead Sponsor: Charikleia Stefanaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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 Criteria

1.Short-bowel syndrome patients, with concurrent D-lactic acidosis.
2.Current hospitalization for any reason.
3.Co-morbid infection of any kind.
4.Co-morbid hereditary and/or acquired immune system deficiency.
5.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.
6.Ingestion of antibiotics < 1 month, prior enrolment and/or intake of yogurts and products containing probiotics or any immune-compromising agent, whatsoever.
7.Diarrhoea, due to the probiotics administration, that lasts more than 3 days and/or causes severe dehydration, independently of its duration.
8.Current detection of HBsAg, HBcAb presence and/or established diagnosis of hepatic disorders of any nature.
9.Inability to commit to clinical trial follow-up.
10.Atopic dermatitis.
11.Epilepsy.
12.Established or possible pregnancy.
13.Presence of metal prostheses, due to orthopaedic surgery or otherwise or implanted devices such as pacemakers.
14.Established, chronic life-threatening diseases, such as neoplasias.

Study & Design

• Study Type: Interventional
• Study Design: Not specified