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Obesity - Inflammation - Metabolic Disease: Effect of Lactobacillus Casei Shirota

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ClinicalTrials.gov Identifier: NCT01182844
Recruitment Status : Completed
First Posted : August 17, 2010
Results First Posted : April 2, 2020
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Vanessa Stadlbauer-Koellner, MD, Medical University of Graz

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Metabolic Syndrome
Intervention Dietary Supplement: Lactobacillus casei Shirota
Enrollment 30
Recruitment Details Thirty-five subjects were screened for the study between January and August 2010; 30 patients were finally included, whereof 28 finished the study (2 dropped out due to withdrawal of informed consent). Five patients did not fulfill the inclusion criterion of fasting glucose above 100 mg/dl at the day of screening any more.
Pre-assignment Details  
Arm/Group Title Control Lactobacillus Casei Shirota
Hide Arm/Group Description Usual care

3 bottles of Yakult(R) light per day

Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day

Period Title: Overall Study
Started 15 15
Completed 15 13
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             2
Arm/Group Title Control Lactobacillus Casei Shirota Total
Hide Arm/Group Description Usual care

3 bottles of Yakult(R) light per day

Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day

Total of all reporting groups
Overall Number of Baseline Participants 15 13 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 13 participants 28 participants
54.5  (8.9) 51.5  (11.4) 53.0  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 13 participants 28 participants
Female
6
  40.0%
4
  30.8%
10
  35.7%
Male
9
  60.0%
9
  69.2%
18
  64.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 13 participants 28 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
15
 100.0%
13
 100.0%
28
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change of Neutrophil Phagocytosis From Baseline to 3 Months
Hide Description The Phagotest® (Orpegen Pharma, Heidelberg, Germany) is used to measure phagocytosis by using Fluorescein isothiocyanate (FITC)-labelled opsonized E. coli bacteria.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Lactobacillus Casei Shirota
Hide Arm/Group Description:
Usual care

3 bottles of Yakult(R) light per day

Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day

Overall Number of Participants Analyzed 15 13
Mean (Standard Deviation)
Unit of Measure: percentage of monocytes and granulocytes
0.06  (23.98) 3.48  (18.83)
2.Primary Outcome
Title Change of Burst (%) From Baseline to 3 Months
Hide Description

The Phagotest® (Orpegen Pharma, Heidelberg, Germany) is used to measure phagocytosis by using FITC-labelled opsonized E. coli bacteria.

The Phagoburst® kit (Orpegen Pharma, Heidelberg, Germany) is used to determine the percentage of neutrophils that produce reactive oxidants with or without stimulation.

Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Lactobacillus Casei Shirota
Hide Arm/Group Description:
Usual care

3 bottles of Yakult(R) light per day

Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day

Overall Number of Participants Analyzed 15 13
Mean (Standard Deviation)
Unit of Measure: percent
-8.68  (31.40) -12.69  (32.96)
3.Secondary Outcome
Title Change in Indices of Glucose Tolerance and Insulin Resistance
Hide Description change in indices of glucose tolerance and insulin resistance (frequently sampled in an oral glucose tolerance test) at baseline and after 3 months Homeostasis model assessment (HOMA)- Insulin Resistance (IR): HOMA is calculated by [fasting glucose*fasting insulin/22.5] insulin (U/L), glucose (mmol/l) - higher values indicating more severe insulin resistance Quantitativer Insulin Sensitivitäts-Check Index (QUCIKI): QUICKI is calculated by [1/log (insulin0)+log(glucose0)] insulin (mU/L), glucose (mg/dL) - lower values indicating a improvement of insulin sensitivity Insulin Sensitivity Index (ISI): 0.222-00333*BMI - 0.0000779*Ins120 -0.0004222*age insulin (mU/L) lower values indicating a improvement of insulin sensitivity
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Lactobacillus Casei Shirota
Hide Arm/Group Description:
Usual care

3 bottles of Yakult(R) light per day

Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day

Overall Number of Participants Analyzed 15 13
Mean (Standard Deviation)
Unit of Measure: no unit - indices
HOMA-IR -0.5  (2.2) 0.1  (1.9)
QUICKI 0  (0.03) 0  (0.05)
Insulin sensitivity index (ISI) 0.004  (0.027) 0.020  (0.019)
4.Secondary Outcome
Title Change of Gut Permeability From Baseline to 3 Months
Hide Description Change of gut permeability (lactulose/mannitol-test) from Baseline to 3 months
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Lactobacillus Casei Shirota
Hide Arm/Group Description:
Usual care

3 bottles of Yakult(R) light per day

Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day

Overall Number of Participants Analyzed 15 13
Mean (Standard Deviation)
Unit of Measure: ratio
-0.01  (0.05) -0.01  (00.06)
5.Secondary Outcome
Title Change in oxLDL (Oxidative Low Density Lipoprotein) From Baseline to 3 Months
Hide Description [Not Specified]
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Lactobacillus Casei Shirota
Hide Arm/Group Description:
Usual care

3 bottles of Yakult(R) light per day

Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day

Overall Number of Participants Analyzed 15 13
Mean (Standard Deviation)
Unit of Measure: mU/mL
-55  (197) -32  (74)
6.Secondary Outcome
Title Change in Interleukin-6 (IL-6) From Baseline to 3 Months
Hide Description [Not Specified]
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Lactobacillus Casei Shirota
Hide Arm/Group Description:
Usual care

3 bottles of Yakult(R) light per day

Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day

Overall Number of Participants Analyzed 15 13
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
0
(-3.47 to 0.98)
-2.98
(-4.53 to -0.13)
7.Secondary Outcome
Title Change in Interleukin-10 (IL-10) From Baseline to 3 Months
Hide Description [Not Specified]
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Lactobacillus Casei Shirota
Hide Arm/Group Description:
Usual care

3 bottles of Yakult(R) light per day

Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day

Overall Number of Participants Analyzed 15 13
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
0
(-10.64 to 9.89)
-7.05
(-12.08 to 0)
Time Frame Adverse events were collected for 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Lactobacillus Casei Shirota
Hide Arm/Group Description Usual care

3 bottles of Yakult(R) light per day

Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day

All-Cause Mortality
Control Lactobacillus Casei Shirota
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/13 (0.00%)    
Hide Serious Adverse Events
Control Lactobacillus Casei Shirota
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/13 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Lactobacillus Casei Shirota
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      2/13 (15.38%)    
Gastrointestinal disorders     
Flatulence   0/15 (0.00%)  0 2/13 (15.38%)  4
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Norbert Tripolt
Organization: Medical University of Graz
Phone: +43 316 385 ext 78038
EMail: norbert.tripolt@medunigraz.at
Layout table for additonal information
Responsible Party: Vanessa Stadlbauer-Koellner, MD, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01182844    
Other Study ID Numbers: vs09.2008
First Submitted: August 13, 2010
First Posted: August 17, 2010
Results First Submitted: March 19, 2020
Results First Posted: April 2, 2020
Last Update Posted: September 29, 2020