NCT02469558

Brief Summary

Obesity and type 2 diabetes are a pandemic disease leading to a high morbidity and mortality. Probiotic modulation of gut flora is a possible therapeutic mechanism. The aim of this study is to investigate and compare thoroughly the effect of a multispecies probiotic on glycaemic control, gut microbiota and gut permeability in patients with metabolic syndrome and diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

3.3 years

First QC Date

June 3, 2015

Last Update Submit

February 5, 2020

Conditions

DiabetesObesity

Outcome Measures

Primary Outcomes (1)

  • insulin sensitivity

    meal tolerance test

    12 months

Other Outcomes (6)

  • gut microbiota composition

    12 months

  • gut permeability

    12 months

  • endotoxin

    12 months

  • +3 more other outcomes

Study Arms (2)

probiotic

ACTIVE COMPARATOR

Winclove 851 and 110 consist of 6g of a probiotic mixture containing Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19, Lactococcus lactis W58 at a concentration of 2.5 x 109 cfu/g and 10g of a prebiotic mixture of galacto-oligosaccharides P11 (GOS), Fructo-oligosaccharides P6 (FOS), Konjac glucomannan P13 (E425), Maltodextrin, Calcium carbonate (E170), Natural Elderflower flavouring, Gum Arabic (E414), Zinc citrate 3-hydrate, Vitamin D3 (Cholecalciferol) and Vitamin B2 (Riboflavin) (E101) daily for 6 months

Dietary Supplement: Winclove 851 and 110

placebo

PLACEBO COMPARATOR

a similar looking and tasting placebo without bacteria

Dietary Supplement: Placebo

Interventions

Winclove 851 and 110DIETARY_SUPPLEMENT

prebiotic and probiotic mixture

probiotic
PlaceboDIETARY_SUPPLEMENT

white powder without pro/probiotic

placebo

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant is willing and able to give informed consent for participation in the study.
  • Age above 18 years
  • Type 2 diabetes
  • BMI 30-40 kg/m²
  • HbA1c ≥ 6.5% (48 mmol/mol)
  • Stable diabetes therapy over 6 months
  • Person commits to the need for long-term follow-up

You may not qualify if:

  • Type 1 diabetes mellitus
  • Maturity Onset Diabetes of the Young (MODY)
  • Secondary diabetes due to a specific disease or glucocorticoid therapy
  • Pregnancy
  • Hypothalamic cause of obesity, Cushing syndrome
  • Major psychiatric diseases including diagnosed eating disorders, history of drug or alcohol abuse
  • History of bariatric surgery
  • Use of probiotics (other than the study product)
  • Inflammatory bowel disease
  • Pancreatitis
  • Chronic non-steroidal anti-inflammatory drug (NSAID) treatment
  • glucagon-like peptide-1 receptor agonist therapy or acarbose therapy
  • Recent (less than 12 weeks) acute myocardial infarction or decompensated heart failure
  • Recent (less than 12 weeks) stroke
  • Known malignancy or any other condition or circumstance, which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz, Department of Internal Medicine

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Diabetes MellitusObesity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vanessa Stadlbauer-Köllner, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

  • Harald Sourij, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 11, 2015

Study Start

September 1, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

February 6, 2020

Record last verified: 2020-02

Locations

AU(1)