Efficacy and safety of Lacticaseibacillus paracasei Lpc-37® in students facing examination stress: A randomized, triple-blind, placebo-controlled clinical trial (the ChillEx study)
Lacticaseibacillus paracasei Lpc-37 (Lpc-37) has previously shown to reduce perceived stress in healthy adults. The ChillEx study investigated whether Lpc-37 reduces stress in a model of chronic examination stress in healthy students. One hundred ninety university students (18–40 y) were randomized...
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2023-10-01
|
| Series: | Brain, Behavior, & Immunity - Health |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S266635462300087X |
| _version_ | 1827854815186649088 |
|---|---|
| author | Sanna M. Mäkelä Síle M. Griffin Jenni Reimari Kara C. Evans Ashley A. Hibberd Nicolas Yeung Alvin Ibarra Jouni Junnila Jari Turunen Ronnie Beboso Balgit Chhokar Timothy G. Dinan John Cryan Elaine Patterson |
| author_facet | Sanna M. Mäkelä Síle M. Griffin Jenni Reimari Kara C. Evans Ashley A. Hibberd Nicolas Yeung Alvin Ibarra Jouni Junnila Jari Turunen Ronnie Beboso Balgit Chhokar Timothy G. Dinan John Cryan Elaine Patterson |
| author_sort | Sanna M. Mäkelä |
| collection | DOAJ |
| description | Lacticaseibacillus paracasei Lpc-37 (Lpc-37) has previously shown to reduce perceived stress in healthy adults. The ChillEx study investigated whether Lpc-37 reduces stress in a model of chronic examination stress in healthy students. One hundred ninety university students (18–40 y) were randomized to take 1.56 × 1010 colony-forming units of Lpc-37 or placebo (1:1) each day for 10 weeks, in a triple-blind, parallel, multicenter clinical trial consisting of six visits: two screening visits, a baseline visit, and visits at 4, 8, and 10 weeks after baseline. The primary objective was to demonstrate that Lpc-37 reduces stress, as measured by the change in state anxiety from baseline to just before the first examination, after 8 weeks using the State Trait Anxiety Inventory (STAI-state). Secondary objectives aimed to demonstrate that Lpc-37 modulates psychological stress-induced symptoms and biomarkers related to mood and sleep. An exploratory analysis of fecal microbiota composition was also conducted. There was no difference between Lpc-37 and placebo groups in the change of STAI-state score (estimate 1.03; 95% confidence interval [CI]: -1.62, 3.67; p = 0.446). None of the secondary outcomes resulted in significant results when corrected for multiplicity, but exploratory results were notable. Results showed an improvement in sleep-disturbance scores (odds ratio 0.30; 95% CI: 0.11, 0.82; p = 0.020) and reduction in duration of sleep (odds ratio 3.52; 95% CI: 1.46, 8.54; p = 0.005) on the Pittsburgh Sleep Quality Index questionnaire after 8 weeks in the Lpc-37 group compared to placebo. A reduction in Bond Lader VAS-alertness was also demonstrated in the Lpc-37 group compared to placebo (estimate −3.97; 95% CI: -7.78, −0.15; p = 0.042) just prior to the examination. Analysis of fecal microbiota found no differences between study groups for alpha and beta diversity or microbiota abundance. Adverse events were similar between groups. Vital signs, safety-related laboratory measures, and gastrointestinal parameters were stable during the trial. In conclusion, probiotic Lpc-37 was safe but had no effect on stress, mood, or anxiety in healthy university students in this model of chronic academic stress. ClinicalTrials.gov: NCT04125810. |
| first_indexed | 2024-03-12T11:35:31Z |
| format | Article |
| id | doaj.art-79b883d5f930460282ea93275ac2f12d |
| institution | Directory Open Access Journal |
| issn | 2666-3546 |
| language | English |
| last_indexed | 2024-03-12T11:35:31Z |
| publishDate | 2023-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Brain, Behavior, & Immunity - Health |
| spelling | doaj.art-79b883d5f930460282ea93275ac2f12d2023-09-01T05:03:12ZengElsevierBrain, Behavior, & Immunity - Health2666-35462023-10-0132100673Efficacy and safety of Lacticaseibacillus paracasei Lpc-37® in students facing examination stress: A randomized, triple-blind, placebo-controlled clinical trial (the ChillEx study)Sanna M. Mäkelä0Síle M. Griffin1Jenni Reimari2Kara C. Evans3Ashley A. Hibberd4Nicolas Yeung5Alvin Ibarra6Jouni Junnila7Jari Turunen8Ronnie Beboso9Balgit Chhokar10Timothy G. Dinan11John Cryan12Elaine Patterson13IFF Health & Biosciences, Kantvik, Finland; Corresponding author.IFF Health & Biosciences, Kantvik, FinlandIFF Health & Biosciences, Kantvik, FinlandIFF Health & Biosciences, Madison, USAIFF Health & Biosciences, Madison, USAIFF Health & Biosciences, Kantvik, FinlandIFF Health & Biosciences, Kantvik, Finland4Pharma Ltd, Turku, Finland4Pharma Ltd, Turku, FinlandMeDiNova North London Dedicated Research Center, London, UKMeDiNova East London Dedicated Research Center, London, UKAPC Microbiome Ireland, University College Cork, Cork, IrelandAPC Microbiome Ireland, University College Cork, Cork, IrelandIFF Health & Biosciences, Kantvik, FinlandLacticaseibacillus paracasei Lpc-37 (Lpc-37) has previously shown to reduce perceived stress in healthy adults. The ChillEx study investigated whether Lpc-37 reduces stress in a model of chronic examination stress in healthy students. One hundred ninety university students (18–40 y) were randomized to take 1.56 × 1010 colony-forming units of Lpc-37 or placebo (1:1) each day for 10 weeks, in a triple-blind, parallel, multicenter clinical trial consisting of six visits: two screening visits, a baseline visit, and visits at 4, 8, and 10 weeks after baseline. The primary objective was to demonstrate that Lpc-37 reduces stress, as measured by the change in state anxiety from baseline to just before the first examination, after 8 weeks using the State Trait Anxiety Inventory (STAI-state). Secondary objectives aimed to demonstrate that Lpc-37 modulates psychological stress-induced symptoms and biomarkers related to mood and sleep. An exploratory analysis of fecal microbiota composition was also conducted. There was no difference between Lpc-37 and placebo groups in the change of STAI-state score (estimate 1.03; 95% confidence interval [CI]: -1.62, 3.67; p = 0.446). None of the secondary outcomes resulted in significant results when corrected for multiplicity, but exploratory results were notable. Results showed an improvement in sleep-disturbance scores (odds ratio 0.30; 95% CI: 0.11, 0.82; p = 0.020) and reduction in duration of sleep (odds ratio 3.52; 95% CI: 1.46, 8.54; p = 0.005) on the Pittsburgh Sleep Quality Index questionnaire after 8 weeks in the Lpc-37 group compared to placebo. A reduction in Bond Lader VAS-alertness was also demonstrated in the Lpc-37 group compared to placebo (estimate −3.97; 95% CI: -7.78, −0.15; p = 0.042) just prior to the examination. Analysis of fecal microbiota found no differences between study groups for alpha and beta diversity or microbiota abundance. Adverse events were similar between groups. Vital signs, safety-related laboratory measures, and gastrointestinal parameters were stable during the trial. In conclusion, probiotic Lpc-37 was safe but had no effect on stress, mood, or anxiety in healthy university students in this model of chronic academic stress. ClinicalTrials.gov: NCT04125810.http://www.sciencedirect.com/science/article/pii/S266635462300087XPsychological stressLacticaseibacillus paracasei Lpc-37AnxietyProbiotic |
| spellingShingle | Sanna M. Mäkelä Síle M. Griffin Jenni Reimari Kara C. Evans Ashley A. Hibberd Nicolas Yeung Alvin Ibarra Jouni Junnila Jari Turunen Ronnie Beboso Balgit Chhokar Timothy G. Dinan John Cryan Elaine Patterson Efficacy and safety of Lacticaseibacillus paracasei Lpc-37® in students facing examination stress: A randomized, triple-blind, placebo-controlled clinical trial (the ChillEx study) Brain, Behavior, & Immunity - Health Psychological stress Lacticaseibacillus paracasei Lpc-37 Anxiety Probiotic |
| title | Efficacy and safety of Lacticaseibacillus paracasei Lpc-37® in students facing examination stress: A randomized, triple-blind, placebo-controlled clinical trial (the ChillEx study) |
| title_full | Efficacy and safety of Lacticaseibacillus paracasei Lpc-37® in students facing examination stress: A randomized, triple-blind, placebo-controlled clinical trial (the ChillEx study) |
| title_fullStr | Efficacy and safety of Lacticaseibacillus paracasei Lpc-37® in students facing examination stress: A randomized, triple-blind, placebo-controlled clinical trial (the ChillEx study) |
| title_full_unstemmed | Efficacy and safety of Lacticaseibacillus paracasei Lpc-37® in students facing examination stress: A randomized, triple-blind, placebo-controlled clinical trial (the ChillEx study) |
| title_short | Efficacy and safety of Lacticaseibacillus paracasei Lpc-37® in students facing examination stress: A randomized, triple-blind, placebo-controlled clinical trial (the ChillEx study) |
| title_sort | efficacy and safety of lacticaseibacillus paracasei lpc 37 r in students facing examination stress a randomized triple blind placebo controlled clinical trial the chillex study |
| topic | Psychological stress Lacticaseibacillus paracasei Lpc-37 Anxiety Probiotic |
| url | http://www.sciencedirect.com/science/article/pii/S266635462300087X |
| work_keys_str_mv | AT sannammakela efficacyandsafetyoflacticaseibacillusparacaseilpc37instudentsfacingexaminationstressarandomizedtripleblindplacebocontrolledclinicaltrialthechillexstudy AT silemgriffin efficacyandsafetyoflacticaseibacillusparacaseilpc37instudentsfacingexaminationstressarandomizedtripleblindplacebocontrolledclinicaltrialthechillexstudy AT jennireimari efficacyandsafetyoflacticaseibacillusparacaseilpc37instudentsfacingexaminationstressarandomizedtripleblindplacebocontrolledclinicaltrialthechillexstudy AT karacevans efficacyandsafetyoflacticaseibacillusparacaseilpc37instudentsfacingexaminationstressarandomizedtripleblindplacebocontrolledclinicaltrialthechillexstudy AT ashleyahibberd efficacyandsafetyoflacticaseibacillusparacaseilpc37instudentsfacingexaminationstressarandomizedtripleblindplacebocontrolledclinicaltrialthechillexstudy AT nicolasyeung efficacyandsafetyoflacticaseibacillusparacaseilpc37instudentsfacingexaminationstressarandomizedtripleblindplacebocontrolledclinicaltrialthechillexstudy AT alvinibarra efficacyandsafetyoflacticaseibacillusparacaseilpc37instudentsfacingexaminationstressarandomizedtripleblindplacebocontrolledclinicaltrialthechillexstudy AT jounijunnila efficacyandsafetyoflacticaseibacillusparacaseilpc37instudentsfacingexaminationstressarandomizedtripleblindplacebocontrolledclinicaltrialthechillexstudy AT jariturunen efficacyandsafetyoflacticaseibacillusparacaseilpc37instudentsfacingexaminationstressarandomizedtripleblindplacebocontrolledclinicaltrialthechillexstudy AT ronniebeboso efficacyandsafetyoflacticaseibacillusparacaseilpc37instudentsfacingexaminationstressarandomizedtripleblindplacebocontrolledclinicaltrialthechillexstudy AT balgitchhokar efficacyandsafetyoflacticaseibacillusparacaseilpc37instudentsfacingexaminationstressarandomizedtripleblindplacebocontrolledclinicaltrialthechillexstudy AT timothygdinan efficacyandsafetyoflacticaseibacillusparacaseilpc37instudentsfacingexaminationstressarandomizedtripleblindplacebocontrolledclinicaltrialthechillexstudy AT johncryan efficacyandsafetyoflacticaseibacillusparacaseilpc37instudentsfacingexaminationstressarandomizedtripleblindplacebocontrolledclinicaltrialthechillexstudy AT elainepatterson efficacyandsafetyoflacticaseibacillusparacaseilpc37instudentsfacingexaminationstressarandomizedtripleblindplacebocontrolledclinicaltrialthechillexstudy |