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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000470594
• Date of registration: 13/05/2015
• Prospective Registration: Yes
• Primary sponsor: Charikleia Stefanaki
• Public title: Probiotics use impact on metabolic markers, body composition, gut microbiota and immunity markers in prediabetic adolescents.
• Scientific title: Evaluating the impact of probiotics use on metabolism body composition, gut microbiota and immunity markers in prediabetic patients. - A randomized, blind, placebo-controlled trial.
• Date of first enrolment: 01/06/2015
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12615000470594.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 2 / Phase 3

Countries of recruitment

Greece

Contacts

• Name: Dr Charikleia Stefanaki

• Name: Dr Charikleia Stefanaki

Key inclusion & exclusion criteria

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.


Age minimum: 12 Years
Age maximum: 20 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Prediabetes ;
Prediabetes

Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

Metabolic and Endocrine - Diabetes

Inflammatory and Immune System - Autoimmune diseases

Intervention(s)

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.

Primary Outcome(s)

The primary outcome is composite. Blood measurement of
1. HbA1C test
2. Fasting plasma glucose
3. Oral Glucose Tolerance Test [Baseline and 16 weeks after enrolment.]

Secondary Outcome(s)

- Human body composition as assessed by Bio-impedance device and bio-impedance spectrometry device.
[Baseline and 16 weeks weeks after enrolment.
]

- Psychometric questionnaires DASS21, PSS-14, STAI-C, Problems and Difficulties Questionnaire.[Baseline and after enrolment.]

This is composite and will be comprised of: serum assays of glucose, insulin, pro-insulin, adiponectin, C-Peptide, leptin, hs-CRP, Interleukin IL-6, Interleukin IL-8, Tumor Necrosis Factor Alpha (TNFa), Plasminogen Activator Inhibitor 1 (PAI-1) concentrations.
[Baseline and after enrolment.]

- Gut flora, via s16 PCR testing.
[Baseline and 4 months after enrolment]

- ECL-IAA, mIAA, GAD65, ZnT8, IA2 antibodies in whole blood.
[Baseline and 4 months after enrolment.]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Athens University Greece

Secondary Sponsor(s)

1st Department of Pediatrics,

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committee of 1st Department of Pediatrics, Athens University Medical School