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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.
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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.
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Secondary ID [1]
284852
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prediabetes
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Condition category
Condition code
Metabolic and Endocrine
292586
292586
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0
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Diabetes
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Oral and Gastrointestinal
295188
295188
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0
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Normal oral and gastrointestinal development and function
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Inflammatory and Immune System
295189
295189
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0
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
289649
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Prevention
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Comparator / control treatment
2 sachets of inactive cellulose daily, orally, for 4 months
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Control group
Placebo
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Outcomes
Primary outcome [1]
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The primary outcome is composite. Blood measurement of
1. HbA1C test
2. Fasting plasma glucose
3. Oral Glucose Tolerance Test
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Assessment method [1]
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Timepoint [1]
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Baseline and 16 weeks after enrolment.
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Secondary outcome [1]
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- Human body composition as assessed by Bio-impedance device and bio-impedance spectrometry device.
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Assessment method [1]
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Timepoint [1]
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Baseline and 16 weeks weeks after enrolment.
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Secondary outcome [2]
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- Gut flora, via s16 PCR testing.
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Assessment method [2]
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Timepoint [2]
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Baseline and 4 months after enrolment
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Secondary outcome [3]
314106
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- ECL-IAA, mIAA, GAD65, ZnT8, IA2 antibodies in whole blood.
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Assessment method [3]
314106
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Timepoint [3]
314106
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Baseline and 4 months after enrolment.
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Secondary outcome [4]
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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.
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Assessment method [4]
314107
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Timepoint [4]
314107
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Baseline and after enrolment.
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Secondary outcome [5]
314108
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- Psychometric questionnaires DASS21, PSS-14, STAI-C, Problems and Difficulties Questionnaire.
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Assessment method [5]
314108
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Timepoint [5]
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Baseline and after enrolment.
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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
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Minimum age
12
Years
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Maximum age
20
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
Nil
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Phase
Phase 2 / Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
30/06/2015
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Actual
1/06/2015
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Date of last participant enrolment
Anticipated
31/08/2017
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
6394
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Greece
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State/province [1]
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Athens, Attiki
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Athens University Greece
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Address [1]
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Alkmanos 18 Str
Unit of Applied Research in Endocrinology and Diabetes, Athens University Medical School, Athens, Greece.
18 Alkmanos Street, Athens 11528, Greece.
Tel: +30 6937036030.
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Country [1]
290661
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Greece
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Primary sponsor type
Individual
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Name
Charikleia Stefanaki
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Address
34 VYZANTIOU STR
Athens, Attiki
12242
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Country
Greece
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Secondary sponsor category [1]
289354
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Hospital
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Name [1]
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1st Department of Pediatrics,
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Address [1]
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Thivon & Levadeias
11527, Goudi
Athens
Greece
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Country [1]
289354
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Greece
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Ethics Committee of 1st Department of Pediatrics, Athens University Medical School
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Ethics committee address [1]
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First Department of Pediatrics, Athens University Medical School Athens
Thivon & Levadeias
11527, Goudi
Athens
Greece
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Ethics committee country [1]
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Greece
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Date submitted for ethics approval [1]
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17/12/2014
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Approval date [1]
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26/02/2015
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Ethics approval number [1]
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Summary
Brief 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.
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
364
364
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/AnzctrAttachments/364169-Ethics Committee.pdf
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Contacts
Principal investigator
Name
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Dr Charikleia Stefanaki
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Address
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Charikleia Stefanaki, MD, MSc
34 VYZANTIOU STR
Athens, 12242
Greece
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Country
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Greece
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Phone
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+306937036030
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Charikleia Stefanaki
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Address
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Charikleia Stefanaki, MD, MSc
34 VYZANTIOU STR
Athens, 12242
Greece
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Country
39735
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Greece
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Phone
39735
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+306937036030
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Fax
39735
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Email
39735
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[email protected]
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Contact person for scientific queries
Name
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Dr Charikleia Stefanaki
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Address
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Charikleia Stefanaki, MD, MSc
34 VYZANTIOU STR
Athens, 12242
Greece
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Country
39736
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Greece
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Phone
39736
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+306937036030
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Fax
39736
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Email
39736
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
The 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.
2018
https://dx.doi.org/10.1016/j.conctc.2018.06.002
Embase
Probiotics in adolescent prediabetes: A pilot RCT on glycemic control and intestinal bacteriome.
2019
https://dx.doi.org/10.3390/jcm8101743
N.B. These documents automatically identified may not have been verified by the study sponsor.
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