A Healthy Vaginal Microbiota Remains Stable during Oral Probiotic Supplementation: A Randomised Controlled Trial

The primary objective of this randomised, placebo-controlled, triple-blind study was to assess whether orally consumed <i>Lactobacillus acidophilus</i> La-14 (La-14) and <i>Lacticaseibacillus rhamnosus</i> HN001 (HN001) colonise a healthy human vagina. Furthermore, potential...

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Main Authors: Anna Lyra, Reeta Ala-Jaakkola, Nicolas Yeung, Neeta Datta, Kara Evans, Ashley Hibberd, Markus J. Lehtinen, Sofia D. Forssten, Alvin Ibarra, Tommi Pesonen, Jouni Junnila, Arthur C. Ouwehand, Keith Baranowski, Johanna Maukonen, Gordon Crawford, Liisa Lehtoranta
Format: Article
Language:English
Published: MDPI AG 2023-02-01
Series:Microorganisms
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Online Access:https://www.mdpi.com/2076-2607/11/2/499
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author Anna Lyra
Reeta Ala-Jaakkola
Nicolas Yeung
Neeta Datta
Kara Evans
Ashley Hibberd
Markus J. Lehtinen
Sofia D. Forssten
Alvin Ibarra
Tommi Pesonen
Jouni Junnila
Arthur C. Ouwehand
Keith Baranowski
Johanna Maukonen
Gordon Crawford
Liisa Lehtoranta
author_facet Anna Lyra
Reeta Ala-Jaakkola
Nicolas Yeung
Neeta Datta
Kara Evans
Ashley Hibberd
Markus J. Lehtinen
Sofia D. Forssten
Alvin Ibarra
Tommi Pesonen
Jouni Junnila
Arthur C. Ouwehand
Keith Baranowski
Johanna Maukonen
Gordon Crawford
Liisa Lehtoranta
author_sort Anna Lyra
collection DOAJ
description The primary objective of this randomised, placebo-controlled, triple-blind study was to assess whether orally consumed <i>Lactobacillus acidophilus</i> La-14 (La-14) and <i>Lacticaseibacillus rhamnosus</i> HN001 (HN001) colonise a healthy human vagina. Furthermore, potential effects on vaginal microbiota and immune markers were explored. Fifty women devoid of vaginal complaints (Nugent score 0–3 and vaginal pH ≤ 4.5) were randomised into a 2-week intervention with either La-14 and HN001 as the verum product or a comparable placebo. Vaginal swab samples were collected at baseline, after one and two weeks of intervention, and after a one-week follow-up, for assessing colonisation of the supplemented lactobacilli, vaginal microbiota, and six specific immune markers. Colonisation of <i>L. acidophilus</i> and <i>L. rhamnosus</i> was not observed above the assay detection limit (5.29 and 5.11 log 10 genomes/swab for <i>L. acidophilus</i> and <i>L. rhamnosus</i>, respectively). Vaginal microbiotas remained stable and predominated by lactobacilli throughout the intervention, and vaginal pH remained optimal (at least 90% of participants in both groups had pH 4.0 or 4.5 throughout the study). Immune markers elafin and human β-defensin 3 (HBD-3) were significantly decreased in the verum group (<i>p</i> = 0.022 and <i>p</i> = 0.028, respectively) but did not correlate with any microbiota changes. Adverse events raised no safety concerns, and no undesired changes in the vaginal microbiota or immune markers were detected.
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spelling doaj.art-6f3b64dc70a14c0b9d4312e3d13fbd122023-11-16T22:16:44ZengMDPI AGMicroorganisms2076-26072023-02-0111249910.3390/microorganisms11020499A Healthy Vaginal Microbiota Remains Stable during Oral Probiotic Supplementation: A Randomised Controlled TrialAnna Lyra0Reeta Ala-Jaakkola1Nicolas Yeung2Neeta Datta3Kara Evans4Ashley Hibberd5Markus J. Lehtinen6Sofia D. Forssten7Alvin Ibarra8Tommi Pesonen9Jouni Junnila10Arthur C. Ouwehand11Keith Baranowski12Johanna Maukonen13Gordon Crawford14Liisa Lehtoranta15IFF Health & Biosciences, 02460 Kantvik, FinlandIFF Health & Biosciences, 02460 Kantvik, FinlandIFF Health & Biosciences, 02460 Kantvik, FinlandIFF Health & Biosciences, 02460 Kantvik, FinlandIFF Health & Biosciences, Madison, WI 53716, USAIFF Health & Biosciences, Madison, WI 53716, USAIFF Health & Biosciences, 02460 Kantvik, FinlandIFF Health & Biosciences, 02460 Kantvik, FinlandIFF Health & Biosciences, 02460 Kantvik, FinlandOy 4Pharma Ltd., 20520 Turku, FinlandEstiMates Oy, 20520 Turku, FinlandIFF Health & Biosciences, 02460 Kantvik, FinlandCPS Research, Glasgow G20 7BE, UKIFF Health & Biosciences, 02460 Kantvik, FinlandCPS Research, Glasgow G20 7BE, UKIFF Health & Biosciences, 02460 Kantvik, FinlandThe primary objective of this randomised, placebo-controlled, triple-blind study was to assess whether orally consumed <i>Lactobacillus acidophilus</i> La-14 (La-14) and <i>Lacticaseibacillus rhamnosus</i> HN001 (HN001) colonise a healthy human vagina. Furthermore, potential effects on vaginal microbiota and immune markers were explored. Fifty women devoid of vaginal complaints (Nugent score 0–3 and vaginal pH ≤ 4.5) were randomised into a 2-week intervention with either La-14 and HN001 as the verum product or a comparable placebo. Vaginal swab samples were collected at baseline, after one and two weeks of intervention, and after a one-week follow-up, for assessing colonisation of the supplemented lactobacilli, vaginal microbiota, and six specific immune markers. Colonisation of <i>L. acidophilus</i> and <i>L. rhamnosus</i> was not observed above the assay detection limit (5.29 and 5.11 log 10 genomes/swab for <i>L. acidophilus</i> and <i>L. rhamnosus</i>, respectively). Vaginal microbiotas remained stable and predominated by lactobacilli throughout the intervention, and vaginal pH remained optimal (at least 90% of participants in both groups had pH 4.0 or 4.5 throughout the study). Immune markers elafin and human β-defensin 3 (HBD-3) were significantly decreased in the verum group (<i>p</i> = 0.022 and <i>p</i> = 0.028, respectively) but did not correlate with any microbiota changes. Adverse events raised no safety concerns, and no undesired changes in the vaginal microbiota or immune markers were detected.https://www.mdpi.com/2076-2607/11/2/499vaginal colonisationmicrobiotaimmune markerslactobacilliprobiotics<i>Lactobacillus acidophilus</i>
spellingShingle Anna Lyra
Reeta Ala-Jaakkola
Nicolas Yeung
Neeta Datta
Kara Evans
Ashley Hibberd
Markus J. Lehtinen
Sofia D. Forssten
Alvin Ibarra
Tommi Pesonen
Jouni Junnila
Arthur C. Ouwehand
Keith Baranowski
Johanna Maukonen
Gordon Crawford
Liisa Lehtoranta
A Healthy Vaginal Microbiota Remains Stable during Oral Probiotic Supplementation: A Randomised Controlled Trial
Microorganisms
vaginal colonisation
microbiota
immune markers
lactobacilli
probiotics
<i>Lactobacillus acidophilus</i>
title A Healthy Vaginal Microbiota Remains Stable during Oral Probiotic Supplementation: A Randomised Controlled Trial
title_full A Healthy Vaginal Microbiota Remains Stable during Oral Probiotic Supplementation: A Randomised Controlled Trial
title_fullStr A Healthy Vaginal Microbiota Remains Stable during Oral Probiotic Supplementation: A Randomised Controlled Trial
title_full_unstemmed A Healthy Vaginal Microbiota Remains Stable during Oral Probiotic Supplementation: A Randomised Controlled Trial
title_short A Healthy Vaginal Microbiota Remains Stable during Oral Probiotic Supplementation: A Randomised Controlled Trial
title_sort healthy vaginal microbiota remains stable during oral probiotic supplementation a randomised controlled trial
topic vaginal colonisation
microbiota
immune markers
lactobacilli
probiotics
<i>Lactobacillus acidophilus</i>
url https://www.mdpi.com/2076-2607/11/2/499
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