Evaluation of the Efficacy of a Probiotic Product as an Adjuvant Treatment for Vulvovaginal Candidiasis
Open-label, randomized clinical trial with a control group and a 4-week intervention period. The study will evaluate the efficacy of the probiotic supplement Bioithas WOMAN® as an adjunctive treatment in women with clinically suspected vulvovaginal candidiasis (VVC).
All participants will receive the antifungal treatment prescribed by the investigator. Participants allocated to the probiotic group will additionally receive Bioithas WOMAN®, supplied as a bottle containing 30 capsules, to be taken during the 4-week intervention period.
The study includes two on-site visits: Visit 1 (baseline) and Visit 2 (week 4/end of study). At baseline, demographic data, relevant gynecological history, VVC risk factors, clinical characteristics of the current episode, concomitant diseases, and usual pharmacological treatments will be recorded. Clinical symptoms associated with VVC, including abnormal vaginal discharge, pruritus, burning sensation, irritation, and dyspareunia, will be assessed, together with the Vaginitis Symptom Score (VSS).
At both visits, vaginal pH will be measured using an indicator strip applied to the vaginal mucosa. A vaginal sample will also be collected using a sterile swab for microbiological culture of Candida and semiquantitative assessment of Lactobacillus. Although randomization will be performed in women with clinical suspicion of VVC, microbiological confirmation by culture will be obtained after inclusion.
At the final visit, the same clinical and microbiological variables will be reassessed. Concomitant treatments, relevant follow-up observations, and any adverse events reported during the study will also be recorded. In the probiotic group, adherence to treatment will be assessed by counting the remaining capsules.
調査の概要
詳細な説明
Open-label, randomized clinical trial with a control group and a 4-week intervention period.
During the study, 2 on-site visits will be carried out:
Visit 1 (V1) - Study start: Inclusion of cases and controls Visit 2 (V2) - End of study: Week 4 of treatment and follow-up
The procedures performed at each visit are described below:
Visit 1 (V1) - Study start
Participation in the study will be proposed to patients attending the Gynecology outpatient clinics of Torrevieja University Hospital with a clinical suspicion, in the investigator's judgment, of vulvovaginal candidiasis (VVC). The investigator will provide them with the patient information sheet so that potential participants can understand the study procedures and objectives after carefully reading it, as well as ask any questions that may arise.
If the participant expresses interest in taking part in the study, she will be given two copies of the informed consent form to complete and sign, so that her willingness to participate in the study is duly documented.
After this, all inclusion and exclusion criteria will be checked one by one, so that the volunteer may ultimately participate in the study if all inclusion criteria and none of the exclusion criteria are met. At that point, she will be assigned a clinical trial participant number in order of inclusion, by which she will be identified.
The following data will be collected in the Case Report Form (CRF):
- Demographic data: age, BMI, concomitant diseases, and usual pharmacological treatments.
- Clinical characteristics of the VVC episode: predominant symptoms, severity of the clinical condition, and prescribed antifungal treatment.
- Relevant gynecological history and VVC risk factors.
The clinical variables under study will be collected:
- Presence or absence (yes/no) of the usual symptoms associated with VVC: Abnormal vaginal discharge Pruritus Burning sensation Irritation Dyspareunia
- Vaginitis Symptom Score (VSS)
- In addition, vaginal pH will be measured using a pH indicator strip applied to the vaginal mucosa.
- A vaginal sample will also be collected for microbiological culture of Candida and culture for semiquantitative assessment of Lactobacillus.
The vaginal sample will be collected using a sterile swab. The swab will be rubbed and rotated over the vaginal mucosa to obtain secretion. The collected sample will be placed in the transport medium indicated by the center's laboratory, appropriately labeled, and sent for microbiological culture of Candida and Lactobacillus following the laboratory's standard procedures.
According to the randomization list, participants will be assigned to either the treatment group or the control group. Randomization will be performed in patients with clinical suspicion of VVC, although microbiological confirmation by culture will be carried out after inclusion.
Participants assigned to the treatment group will be provided with a bottle containing 30 capsules of the probiotic supplement Bioithas WOMAN®, which they will add to the antifungal treatment prescribed at the visit, whereas participants in the control group will receive only the antifungal treatment.
Visit 2 (V2) - End of study
As in Visit 1, the clinical variables under study will be collected:
- Presence or absence of the usual symptoms associated with vaginitis
- Vaginitis Symptom Score (VSS)
In addition, the following will be performed:
- Vaginal pH measurement
- Vaginal sample for microbiological culture of Candida and culture for semiquantitative assessment of Lactobacillus
Additionally, concomitant treatments and relevant observations during the follow-up period will be recorded, as well as any reported adverse events.
For participants in the probiotic group, treatment adherence will be assessed by counting the remaining capsules.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Juan Gabriel Agüera Santos
- 電話番号：623 02 25 86
- メール：juan.aguera@bioithas.com
研究連絡先のバックアップ
- 名前：Vicente Navarro López
- メール：vicente.navarrro@bioithas.com
研究場所
-
-
Alicante
-
Torrevieja、Alicante、スペイン、03186
- 募集
- Hospital Universitario de Torrevieja
-
コンタクト：
- Ana María Navarro Fenoll
- 電話番号：608 33 07 27
- メール：navarro_anafen@gva.es
-
コンタクト：
- Eduardo Cazorla Amorós
- メール：cazorla_edu@gva.es
-
主任研究者：
- Eduardo Cazorla Amorós, MD
-
副調査官：
- Duska Beric, MD
-
副調査官：
- Elisa Peñalver Escolano, MD
-
副調査官：
- Ana María Navarro Fenoll, SN
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Women of reproductive age who use effective contraceptive methods during the course of the study.
- Clinical suspicion of vulvovaginal candidiasis, in the investigator's judgment, based on the presence of symptoms - e.g., pruritus, burning sensation, irritation, dyspareunia and/or abnormal vaginal discharge - and/or compatible clinical findings.
- Possibility of collecting a vaginal sample at the baseline visit for microbiological analysis.
- Ability and willingness to comply with the study procedures and to sign the informed consent form
Exclusion Criteria:
- Menstruation at the time of inclusion.
- Pregnancy or breastfeeding.
- Menopause or perimenopause.
- Diabetes mellitus.
- Presence of immunocompromised status or treatment with immunosuppressants within the 3 months prior to inclusion in the trial.
- Vaginal coinfection in addition to vulvovaginal candidiasis.
- Severe chronic diseases or other active infections that may interfere with the clinical assessment of vulvovaginal candidiasis, in the investigator's judgment.
- History of intolerance or hypersensitivity to the intervention products.
- Treatment with antifungals or probiotic supplements in the month prior to inclusion in the trial.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：対照群
|
|
|
実験的：Bioithas WOMAN®
|
≥1 × 10⁹ CFU of a probiotic blend composed of Lacticaseibacillus rhamnosus, Lactiplantibacillus plantarum, and Kluyveromyces marxianus
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in the number and percentage of patients with complete absence of symptoms associated with VVC at the end of the 4-week treatment period between the study groups, compared with the baseline visit.
時間枠：4 weeks
|
The complete absence of symptoms associated with VVC will be assessed.
The symptoms evaluated will include: abnormal vaginal discharge, pruritus, burning sensation, irritation, and dyspareunia
|
4 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in the number and percentage of patients with absence of each individual symptom associated with VVC at the end of the 4-week treatment period between the study groups, compared with the baseline visit.
時間枠：4 weeks
|
The absence of each symptom associated with VVC will be assessed separately.
The symptoms evaluated will include: abnormal vaginal discharge, pruritus, burning sensation, irritation, and dyspareunia
|
4 weeks
|
|
Changes in the Vaginitis Symptom Score (VSS) at the end of the 4-week intervention period between the study groups, compared with the baseline visit
時間枠：4 weeks
|
Vaginistis Symptom Score (VSS) is a clinical scale used to assess the presence and severity of symptoms associated with vulvovaginal candidiasis, based on the assessment of the main symptoms reported by the patient. The VSS includes the evaluation of the following symptoms: Abnormal vaginal discharge Vaginal pruritus Burning sensation Vaginal irritation Dyspareunia Each symptom is scored individually according to its intensity, using an ordinal severity scale, usually defined as: 0 = Absent
The total VSS score is obtained as the sum of the individual scores for each symptom, resulting in a total range from 0 to 15 points, where higher values indicate greater severity of vaginal symptoms. |
4 weeks
|
|
Difference in the number and percentage of patients with a negative vaginal culture for Candida at the end of the 4-week treatment period between the study groups, compared with those with an initially positive culture at the baseline visit
時間枠：4 weeks
|
Among patients in whom the diagnosis of vulvovaginal candidiasis is microbiologically confirmed by a positive Candida culture result, a follow-up culture will be performed at 4 weeks to assess culture negativization after the administered treatment
|
4 weeks
|
|
Adherence to the investigational product based on the count of capsules returned at the end of the treatment period among participants in the probiotic group
時間枠：4 weeks
|
For participants in the probiotic group, the remaining treatment will be collected to assess adherence during the treatment period
|
4 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number and severity of total adverse events reported by patients during the 4-week treatment period
時間枠：4 weeks
|
All adverse events occurring during the study follow-up period will be collected
|
4 weeks
|
|
Number and severity of adverse events potentially attributable to the study product during the 4-week treatment period
時間枠：4 weeks
|
Adverse events potentially attributable to the study product will be collected during the follow-up period, especially those of a digestive nature
|
4 weeks
|
|
Changes in vaginal pH at the end of the 4-week intervention period between the study groups, compared with the baseline visit
時間枠：4 weeks
|
Vaginal pH will be measured using an indicator strip at the beginning and end of the study, with the aim of assessing possible changes after 4 weeks of follow-up
|
4 weeks
|
|
Changes in the vaginal load of Lactobacillus spp. at the end of the 4-week treatment period between the study groups, compared with the baseline visit.
時間枠：4 weeks
|
Changes in the vaginal load of Lactobacillus spp.
will be assessed by semiquantitative colony count (CFU) obtained through microbiological culture on selective medium
|
4 weeks
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CVV.PROB
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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