Trial Outcomes & Findings for Obesity - Inflammation - Metabolic Disease: Effect of Lactobacillus Casei Shirota (NCT NCT01182844)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

3 months

Results posted on

2020-09-29

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Control Usual care	Lactobacillus Casei Shirota 3 bottles of Yakult(R) light per day Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day
Overall Study STARTED	15	15
Overall Study COMPLETED	15	13
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Usual care	Lactobacillus Casei Shirota 3 bottles of Yakult(R) light per day Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=15 Participants Usual care	Lactobacillus Casei Shirota n=13 Participants 3 bottles of Yakult(R) light per day Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day	Total n=28 Participants Total of all reporting groups
Age, Continuous	54.5 years STANDARD_DEVIATION 8.9 • n=5 Participants	51.5 years STANDARD_DEVIATION 11.4 • n=7 Participants	53.0 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Outcome measures
Measure	Control n=15 Participants Usual care	Lactobacillus Casei Shirota n=13 Participants 3 bottles of Yakult(R) light per day Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day
Change of Neutrophil Phagocytosis From Baseline to 3 Months	0.06 percentage of monocytes and granulocytes Standard Deviation 23.98	3.48 percentage of monocytes and granulocytes Standard Deviation 18.83

PRIMARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Control n=15 Participants Usual care	Lactobacillus Casei Shirota n=13 Participants 3 bottles of Yakult(R) light per day Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day
Change of Burst (%) From Baseline to 3 Months	-8.68 percent Standard Deviation 31.40	-12.69 percent Standard Deviation 32.96

SECONDARY outcome

Timeframe: 3 months

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

Outcome measures

Outcome measures
Measure	Control n=15 Participants Usual care	Lactobacillus Casei Shirota n=13 Participants 3 bottles of Yakult(R) light per day Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day
Change in Indices of Glucose Tolerance and Insulin Resistance HOMA-IR	-0.5 no unit - indices Standard Deviation 2.2	0.1 no unit - indices Standard Deviation 1.9
Change in Indices of Glucose Tolerance and Insulin Resistance QUICKI	0 no unit - indices Standard Deviation 0.03	0 no unit - indices Standard Deviation 0.05
Change in Indices of Glucose Tolerance and Insulin Resistance Insulin sensitivity index (ISI)	0.004 no unit - indices Standard Deviation 0.027	0.020 no unit - indices Standard Deviation 0.019

SECONDARY outcome

Timeframe: 3 months

Change of gut permeability (lactulose/mannitol-test) from Baseline to 3 months

Outcome measures

Outcome measures
Measure	Control n=15 Participants Usual care	Lactobacillus Casei Shirota n=13 Participants 3 bottles of Yakult(R) light per day Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day
Change of Gut Permeability From Baseline to 3 Months	-0.01 ratio Standard Deviation 0.05	-0.01 ratio Standard Deviation 00.06

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Control n=15 Participants Usual care	Lactobacillus Casei Shirota n=13 Participants 3 bottles of Yakult(R) light per day Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day
Change in oxLDL (Oxidative Low Density Lipoprotein) From Baseline to 3 Months	-55 mU/mL Standard Deviation 197	-32 mU/mL Standard Deviation 74

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Control n=15 Participants Usual care	Lactobacillus Casei Shirota n=13 Participants 3 bottles of Yakult(R) light per day Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day
Change in Interleukin-6 (IL-6) From Baseline to 3 Months	0 pg/mL Interval -3.47 to 0.98	-2.98 pg/mL Interval -4.53 to -0.13

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Control n=15 Participants Usual care	Lactobacillus Casei Shirota n=13 Participants 3 bottles of Yakult(R) light per day Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day
Change in Interleukin-10 (IL-10) From Baseline to 3 Months	0 pg/mL Interval -10.64 to 9.89	-7.05 pg/mL Interval -12.08 to 0.0

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lactobacillus Casei Shirota

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control n=15 participants at risk Usual care	Lactobacillus Casei Shirota n=13 participants at risk 3 bottles of Yakult(R) light per day Lactobacillus casei Shirota: 3 bottles of Yakult(R) light per day
Gastrointestinal disorders Flatulence	0.00% 0/15 • Adverse events were collected for 3 months	15.4% 2/13 • Number of events 4 • Adverse events were collected for 3 months

Additional Information

Dr. Norbert Tripolt

Medical University of Graz

Phone: +43 316 385

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place