Trial Outcomes & Findings for Immune-modulatory Effect of Probiotic Strain on Grass Pollen Allergic Individuals (NCT NCT01660698)

Results Overview

A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

0 (baseline), 1 and 2 months

Results posted on

2013-07-12

Participant Flow

Recruitment at the Metabolic Unit, (study no. 11.03.MET, NCT01660698) during the Grass Pollen (GP) season. Twenty seven adults volunteered, of which twenty four who gave written informed consent were screened for clinical history of allergy to GP \> 2 years and a confirmatory skin prick test (SPT) to GP. Twenty subjects were randomized.

Subjects assigned to either: probiotic or placebo groups and taking assigned product for 8 weeks with three visits: V1(at baseline), V2 (4 weeks after treatment) and V3 (8 weeks after treatment).

Participant milestones

Participant milestones
Measure	Placebo maltodextrin powder Maltodextrin : maltodextrin powder	Probiotic probiotic blended in maltodextrin Probiotic : probiotic blended in maltodextrin powder
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immune-modulatory Effect of Probiotic Strain on Grass Pollen Allergic Individuals

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=10 Participants maltodextrin powder Maltodextrin : maltodextrin powder	Probiotic n=10 Participants probiotic blended in maltodextrin Probiotic : probiotic blended in maltodextrin powder	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	34 years n=5 Participants	35.5 years n=7 Participants	34.7 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Switzerland	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 0 (baseline), 1 and 2 months

A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants maltodextrin powder Maltodextrin : maltodextrin powder	Probiotic n=10 Participants probiotic blended in maltodextrin Probiotic : probiotic blended in maltodextrin powder
Comparison of Th2 Cytokines (IL-13) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake) IL13 at V1 (beginning of product intake)	1238 ng/mL Standard Error 1453	720 ng/mL Standard Error 854
Comparison of Th2 Cytokines (IL-13) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake) IL13 at 1 month (4 weeks)	975 ng/mL Standard Error 1019	998 ng/mL Standard Error 1383
Comparison of Th2 Cytokines (IL-13) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake) IL13 at 2 months (8 weeks)	968 ng/mL Standard Error 1206	218 ng/mL Standard Error 151

PRIMARY outcome

Timeframe: 0 (baseline), 1, and 2 months

A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants maltodextrin powder Maltodextrin : maltodextrin powder	Probiotic n=10 Participants probiotic blended in maltodextrin Probiotic : probiotic blended in maltodextrin powder
Comparison of Th2 Cytokines (IL-5) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake) IL-5 at 1 month (4 weeks)	1191 ng/mL Standard Deviation 1005	980 ng/mL Standard Deviation 905
Comparison of Th2 Cytokines (IL-5) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake) IL-5 at 2 months (8 weeks)	1277 ng/mL Standard Deviation 956	323 ng/mL Standard Deviation 301
Comparison of Th2 Cytokines (IL-5) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake) IL-5 at baseline (begining of product intake)	1439 ng/mL Standard Deviation 1501	700 ng/mL Standard Deviation 683

SECONDARY outcome

Timeframe: Measures at baseline, 1, and 2 months

TNSS Questionnaire were distributed at every visit (1 questionnaire for every week). The scored questionnaire were collected at subsequent visits. The symptom scores for nasal congestion, runny nose, nasal itching and sneezing were expressed as weekly sums (scale 0-3 for each symptom). The TNSS was the weekly sum for all the symptoms (scale 0-12). The TNSS data were analyzed as both monthly averages (at V2 and V3 compared to baseline V1) and weekly TNSS scores. Monthly TNSS scores were calculated as average over the 4 weeks preceding the visits. The higher the score is, the worse the outcome is.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants maltodextrin powder Maltodextrin : maltodextrin powder	Probiotic n=10 Participants probiotic blended in maltodextrin Probiotic : probiotic blended in maltodextrin powder
Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake) TNSS score at baseline	4.10 units on a scale Standard Deviation 3.11	4.90 units on a scale Standard Deviation 3.35
Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake) TNSS score at 1 month	3.05 units on a scale Standard Deviation 1.86	3.92 units on a scale Standard Deviation 1.89
Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake) TNSS score at 2 months	3.00 units on a scale Standard Deviation 2.04	1.50 units on a scale Standard Deviation 1.33

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Probiotic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Maurice Beaumont, Principal Investigator

Clinical Development Unit / Metabolic Unit

Phone: +41217858054

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place