Colipral® (Probiotic Strain Escherichia Coli 5C (ECP24®)) for Prevention of Recurrent Cystitis in Menopausal Women
Study to Evaluate the Efficacy and Safety of Colipral® (Probiotic Strain Escherichia Coli 5C (ECP24®)) in the Prevention of Recurrent Cystitis in Menopausal Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Recurrent cystitis, defined as two or more episodes within 6 months or three or more episodes within 12 months, is particularly frequent in menopausal women because of age-related changes in estrogen levels, the urogenital epithelium, and the microbiota. The gastrointestinal tract is considered an important reservoir of uropathogenic bacteria, and intestinal dysbiosis may contribute to recurrent urinary tract infections.
This study is a randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate whether Colipral® (probiotic strain Escherichia coli 5C (ECP24®)) reduces the proportion of menopausal women experiencing recurrent symptomatic cystitis compared with placebo during a 24-week follow-up period. Recurrence is defined as the appearance of urinary symptoms compatible with the need for therapy and confirmed by urine culture.
A total of 134 menopausal women with recurrent cystitis will be enrolled and randomized in a 1:1 ratio to receive either Colipral® or placebo. Participants in the active treatment group will receive one capsule daily for 12 weeks, while participants in the control group will receive an identical placebo for the same duration. The follow-up period will continue beyond treatment discontinuation to evaluate the persistence of the preventive effect.
Secondary objectives include evaluation of the number of cystitis episodes, time to first recurrence, antibiotic consumption, urinary pain assessed by the Visual Analogue Scale (VAS), symptom severity, and quality of life assessed using the UTI-SIQ-8 questionnaire.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Alessandro Messina, MD
- Numéro de téléphone: 011 56 16 111
- E-mail: alessandro.messina@aslbi.piemonte.it
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Menopausal female patients.
- Age between 55 and 70 years.
- Diagnosis of recurrent cystitis: ≥2 episodes in 6 months or ≥3 episodes in 12 months, with at least 1 documented episode from urine culture in the last 12 months (if available).
Exclusion Criteria:
- Complicated urinary tract infections (UTIs) or major complicating factors, including relevant anatomical abnormalities, catheterization, active calculosis, or significant immunosuppression.
- Hormone replacement therapy (HRT) that has been ongoing or discontinued for less than 6 months.
- Pyelonephritis within the past 6 months.
- Ongoing continuous antibiotic prophylactic therapy (or inability to suspend it).
- Chronic inflammatory bowel diseases (ulcerative colitis or Crohn's disease).
- Allergy to the probiotic or its excipients.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Colipral®
Participants will receive Colipral® at a dose of 1 capsule per day, administered in the morning or evening, for 12 weeks.
The study will evaluate the efficacy and safety of Colipral® in the prevention of recurrent cystitis in menopausal women.
|
Colipral® is a probiotic food supplement in gastro-resistant capsules containing the probiotic strain Escherichia coli 5C (ECP24®).
Participants will receive one capsule orally once daily, in the morning or evening, for 12 weeks.
|
|
Comparateur placebo: Placebo
Participants will receive placebo capsules identical in shape, color, and packaging to Colipral®, administered as 1 capsule per day in the morning or evening for 12 weeks.
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Matching placebo identical in shape, color, and packaging to Colipral®, administered orally as one capsule daily in the morning or evening for 12 weeks.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of Participants With at Least One Episode of Symptomatic Cystitis
Délai: 24 weeks
|
Proportion of participants with at least one episode of symptomatic cystitis during the 24-week follow-up period.
Each episode must meet clinical criteria and have microbiological confirmation by urine culture.
|
24 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to First Recurrence
Délai: 24 weeks
|
Time from randomization to the first episode of symptomatic cystitis confirmed by urine culture.
|
24 weeks
|
|
Number of Total Cystitis Episodes
Délai: 24 weeks
|
Total number of symptomatic cystitis episodes during the follow-up period.
|
24 weeks
|
|
Antibiotic Consumption
Délai: 24 weeks
|
Number of antibiotic cycles and total days of antibiotic therapy during follow-up.
|
24 weeks
|
|
Urinary Pain
Délai: 24 weeks
|
Urinary pain assessed using the Visual Analogue Scale (VAS).
|
24 weeks
|
|
Quality of Life and Symptom Severity
Délai: 24 weeks
|
Quality of life and symptom severity assessed using the UTI-SIQ-8 questionnaire.
|
24 weeks
|
Collaborateurs et enquêteurs
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 388/CE, 09.06.2026
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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