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Trial registered on ANZCTR


Registration number
ACTRN12615000470594
Ethics application status
Approved
Date submitted
25/03/2015
Date registered
13/05/2015
Date last updated
14/04/2016
Type of registration
Prospectively registered

Titles & IDs
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.
Secondary ID [1] 284852 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prediabetes 292247 0
Condition category
Condition code
Metabolic and Endocrine 292586 292586 0 0
Diabetes
Oral and Gastrointestinal 295188 295188 0 0
Normal oral and gastrointestinal development and function
Inflammatory and Immune System 295189 295189 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 289649 0
Prevention
Comparator / control treatment
2 sachets of inactive cellulose daily, orally, for 4 months
Control group
Placebo

Outcomes
Primary outcome [1] 292444 0
The primary outcome is composite. Blood measurement of
1. HbA1C test
2. Fasting plasma glucose
3. Oral Glucose Tolerance Test
Timepoint [1] 292444 0
Baseline and 16 weeks after enrolment.
Secondary outcome [1] 308958 0
- Human body composition as assessed by Bio-impedance device and bio-impedance spectrometry device.
Timepoint [1] 308958 0
Baseline and 16 weeks weeks after enrolment.
Secondary outcome [2] 314105 0
- Gut flora, via s16 PCR testing.
Timepoint [2] 314105 0
Baseline and 4 months after enrolment
Secondary outcome [3] 314106 0
- ECL-IAA, mIAA, GAD65, ZnT8, IA2 antibodies in whole blood.
Timepoint [3] 314106 0
Baseline and 4 months after enrolment.
Secondary outcome [4] 314107 0
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.
Timepoint [4] 314107 0
Baseline and after enrolment.
Secondary outcome [5] 314108 0
- Psychometric questionnaires DASS21, PSS-14, STAI-C, Problems and Difficulties Questionnaire.
Timepoint [5] 314108 0
Baseline and after enrolment.

Eligibility
Key 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
Minimum age
12 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1. Evaluation according to the inclusion and exclusion criteria.
2. Written informed consent will be given, either from the patients themselves or from their guardians.
3. Allocation to the group according to sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization will be performed via the online randomization site : www.random.org
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Nil
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/06/2015
Actual
1/06/2015
Date of last participant enrolment
Anticipated
31/08/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 6394 0
Greece
State/province [1] 6394 0
Athens, Attiki

Funding & Sponsors
Funding source category [1] 290661 0
University
Name [1] 290661 0
Athens University Greece
Country [1] 290661 0
Greece
Primary sponsor type
Individual
Name
Charikleia Stefanaki
Address
34 VYZANTIOU STR
Athens, Attiki
12242
Country
Greece
Secondary sponsor category [1] 289354 0
Hospital
Name [1] 289354 0
1st Department of Pediatrics,
Address [1] 289354 0
Thivon & Levadeias
11527, Goudi
Athens
Greece
Country [1] 289354 0
Greece

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292292 0
Ethics Committee of 1st Department of Pediatrics, Athens University Medical School
Ethics committee address [1] 292292 0
Ethics committee country [1] 292292 0
Greece
Date submitted for ethics approval [1] 292292 0
17/12/2014
Approval date [1] 292292 0
26/02/2015
Ethics approval number [1] 292292 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 364 364 0 0
/AnzctrAttachments/364169-Ethics Committee.pdf

Contacts
Principal investigator
Name 39734 0
Dr Charikleia Stefanaki
Address 39734 0
Charikleia Stefanaki, MD, MSc
34 VYZANTIOU STR
Athens, 12242
Greece
Country 39734 0
Greece
Phone 39734 0
+306937036030
Fax 39734 0
Email 39734 0
cstefanak@med.uoa.gr
Contact person for public queries
Name 39735 0
Charikleia Stefanaki
Address 39735 0
Charikleia Stefanaki, MD, MSc
34 VYZANTIOU STR
Athens, 12242
Greece
Country 39735 0
Greece
Phone 39735 0
+306937036030
Fax 39735 0
Email 39735 0
cstefanak@med.uoa.gr
Contact person for scientific queries
Name 39736 0
Charikleia Stefanaki
Address 39736 0
Charikleia Stefanaki, MD, MSc
34 VYZANTIOU STR
Athens, 12242
Greece
Country 39736 0
Greece
Phone 39736 0
+306937036030
Fax 39736 0
Email 39736 0
cstefanak@med.uoa.gr

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe impact of probiotics' administration on glycemic control, body composition, gut microbiome, mitochondria, and other hormonal signals in adolescents with prediabetes - A randomized, controlled trial study protocol.2018https://dx.doi.org/10.1016/j.conctc.2018.06.002
EmbaseProbiotics in adolescent prediabetes: A pilot RCT on glycemic control and intestinal bacteriome.2019https://dx.doi.org/10.3390/jcm8101743
N.B. These documents automatically identified may not have been verified by the study sponsor.