HCP

Vaginal Health

LA-14® AND HN001™ INFORMATION

Study on the effects of an oral lactobacilli and lactoferrin complex in women with intermediate vaginal microbiota.1

Study aim 

To evaluate the changes in Nugent score in women with intermediate vaginal microbiota treated with oral Lactobacillus acidophilus La-14® and Lactobacillus rhamnosus HN001™ mixture, in combination with bovine lactoferrin RCX™ (Respecta®) or placebo, for 15 days.

Study design

Double-blind, randomized, placebo-controlled

Study method

  • 40 women with an intermediate Nugent score, indicating a perturbed vaginal microbiota, and with signs/symptoms of vaginitis/vaginosis were randomized to two treatment groups:
    • Placebo
    • La-14® and HN001™ 5 billion CFU/day with 50 mg of lactoferrin (Respecta®) (Probiotic Combo)
  • Lactobacillus species were analyzed by RT-PCR from vaginal swabs at baseline and at the end of the 15-day probiotic/placebo treatment

Study results

La-14® and HN001™ (Probiotic Combo) helped restore healthy vaginal microbiota and alleviated vaginal symptoms in women with intermediate Nugent scores

  • There was a significant improvement from intermediate to normal Nugent score in the probiotic combo from baseline (P=0.0004)
  • No changes from the baseline in the placebo group were found in the Nugent score
  • The Nugent score was significantly improved for the probiotic combo group compared with the placebo group (P=0.011) at the end of the treatment
  • Vaginal symptoms (itching/discharge) decreased significantly in the probiotic combo group compared to the placebo group (P<0.001)

Evidence-based mixture containing Lactobacillus strains and lactoferrin to prevent recurrent bacterial vaginosis: a double blind, placebo controlled, randomized clinical trial.2

Study aim

To assess the efficacy of L. acidophilus La-14® and L. rhamnosus HN001™, in combination with lactoferrin as adjuvant therapy to metronidazole in women with recurrent bacterial vaginosis (BV).

Study design

Double-blind, randomized, placebo-controlled 

Study method

  • 48 women with symptomatic BV infections were treated with metronidazole (500 mg twice daily) for 7 days and were randomly assigned to take simultaneously orally either:
    • Placebo
    • La-14® and HN001™ with lactoferrin (50 mg)
  • An initial induction phase consisted of two capsules/day for five days (10 billion CFU) followed by one capsule/day for 10 consecutive days (5 billion CFU)
  • One capsule/day for 10 consecutive days was repeated monthly (maintenance phase) during the 6 months of follow-up starting the first day of menstrual cycle, as the menstrual blood increases the vaginal pH and contributes to an increased risk of BV recurrences
  • The clinical cure rate of BV symptoms, microbiological cure rate (Nugent score), and BV recurrence was evaluated during the 6-month study period

Study results

La-14® and HN001 were associated with significant improvement in recurrent BV symptoms

Vaginal discharge

Itching

  • Based on patient-assessed symptoms (absent or present), there were significant improvements in both vaginal discharge and itching after 4 and 6 months of treatment compared with placebo (P<0.05)

La-14® and HN001™ were associated with a significant improvement in overall cure rate 

  • La-14® and HN001™ significantly improved overall cure rate (absence of symptoms and Nugent score <7) at every time point compared with placebo (P<0.01)

La-14® and HN001™ were associated with a significant reduction in BV recurrence rates 

  • La-14® and HN001™ was associated with a significant reduction in the rate of BV recurrence (BV symptoms and Nugent score >3) at 1, 4, and 6, months of follow-up compared with placebo (P<0.05)

Randomized clinical trial in women with Recurrent Vulvovaginal Candidiasis: efficacy of probiotics and lactoferrin as maintenance treatment.3

Study aim

To assess the efficacy of L. acidophilus La-14®, L. rhamnosus HN001™, and lactoferrin on symptoms and recurrence of vulvovaginal candidiasis (VVC) as adjuvant therapy to topical clotrimazole.

Study design

Double-blind, randomized, placebo-controlled 

Study method

  • 48 adult women with symptomatic acute episodes of VVC and a documented anamnestic history of recurrences were treated with a topical clotrimazole (100 mg) for seven days and were randomly assigned to simultaneously orally take either:
    • Placebo
    • La-14® and HN001™ with lactoferrin (50 mg)
  • An initial induction phase consisted of two capsules/day for five days (10 billion CFU) followed by one capsule/day for 10 consecutive days (5 billion CFU)
  • One capsule/day for 10 consecutive days was repeated monthly (maintenance phase) during the 6 months of follow-up in the premenstrual phase or luteal phase, as during this time, hormonal and immunological reasons make the vagina more vulnerable to pathogens and pose a higher risk of VVC recurrences
  • Symptoms, overall cure rate, and recurrence rate were assessed

Study results

La-14® and HN001™ were associated with a significant overall VVC cure rate

  • Absence of VVC was defined as an absence of symptoms and negative candida culture
  • The probiotic combo significantly increased the VVC cure rate compared to placebo at 3 and 6 months of follow-up (P<0.01)

La-14® and HN001™ probiotic combo was associated with a significant improvement of itching and vaginal discharge at 3 and 6 months (P<0.01) (Data not shown)

La-14® and HN001™ were associated with a reduced VVC recurrence rate

  • VVC recurrence rate was defined as the presence of at least 1 symptom and positive candida culture
  • During the six-month follow-up, the VVC recurrence rate was significantly less in the probiotic group vs placebo at 3 and 6 months follow-up (P<0.01)

Vaginal Colonization Data

Lactobacilli vaginal colonization after oral consumption of Respecta® complex: a randomized controlled pilot study.4

Study aim

To determine if Lactobacillus acidophilus La-14® and Lactobacillus rhamnosus HN001™ could be detected in the vaginas of healthy women once consumed.

Study design

Double-blind, randomized, placebo-controlled pilot study

Study method

  • 40 healthy women were randomized to two treatment groups:
    • Placebo (100 mg maltodextrin)
    • La-14® and HN001 10 billion CFU/day with lactoferrin
  • Vaginal swabs were taken at 0, 7, 14, and 21 days and analyzed by quantitative polymerase chain reaction (qPCR) for detection and quantification of DNA of L rhamnosus and L acidophilus
  • Vaginal pH was also measured

Study results

La-14® and HN001™ probiotic combo supplementation increased vaginal recovery of healthy bacteria

  • Compared to baseline, vaginal L. acidophilus levels were significantly increased on days 14 and 21 in the probiotic group (P<0.001).
  • Compared to baseline, vaginal L. rhamnosus levels were increased on days 14 and 21 in the probiotic group (P<0.001)

La-14® and HN001™ probiotic combo supplementation increased transient colonization of healthy bacteria

  • Transient colonization of L. acidophilus (ie, at least double levels from baseline) was observed on days 14 and 21 in 12 (P=0.0225) and 16 (P=0.0001) out of 20 women, respectively, in the probiotic combo group
  • Transient colonization of L. rhamnosus was observed on days 7 and 21 in 16 (P=0.0484) and 17 (P=0.0187) out of 20 women, respectively, in the probiotic combo group
  • No significant transient colonization was found in the placebo group

Bibliography

REFERENCES:

1. Russo R, Edu A, De Seta F. Study on the effects of an oral lactobacilli and lactoferrin complex in women with intermediate vaginal microbiota. Arch Gynecol Obstet. 2018;298(1):139-145. doi: 10.1007/s00404-018-4771-z.  2. Russo R, Karadja E, De Seta F. Evidence-based mixture containing Lactobacillus strains and lactoferrin to prevent recurrent bacterial vaginosis: a double blind, placebo controlled, randomised clinical trial. Benef Microbes. 2019;10(1):19-26. doi: 10.3920/BM2018.0075.  3. Russo R, Superti F, Karadja E, De Seta F. Randomised clinical trial in women with Recurrent Vulvovaginal Candidiasis: Efficacy of probiotics and lactoferrin as maintenance treatment. Mycoses. 2019;62(4):328-335. doi: 10.1111/myc.12883. 4. De Alberti D, Russo R, Terruzzi F, Nobile V, Ouwehand AC. Lactobacilli vaginal colonisation after oral consumption of Respecta® complex: a randomised controlled pilot study. Arch Gynecol Obstet. 2015;292(4):861-867

WHEN PATIENTS NEED TO RESTORE AND MAINTAIN VAGINAL HEALTH AND OVERALL FEMININE WELLNESS, RECOMMEND PRODUCTS WITH THE CLINICALLY RESEARCHED HOWARU® STRAINS LA-14® AND HN001™
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