bacterial vaginosis
Conditions
Interventions
Lactoferrin and Kestose Combination Product Usage
Sponsors
Kimura Fuminori
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: At Primary Registration 1.Adults aged 20 to 46 years (inclusive). 2.Infertility, defined as failure to conceive after >-12 months of attempted conception. 3.Patients clinically suspected or diagnosed with bacterial vaginosis (BV). 4.Patients who provide written informed consent to undergo the Nugent score test, which serves as a pre-registration assessment for this study. At Secondary Registration 1.Patients who have completed primary registration. 2.Bacterial vaginosis confirmed by a Nugent score >-4.
Exclusion criteria
Exclusion criteria: At Primary Registration 1.Patients with known hypersensitivity to bovine lactoferrin or Kestose. 2.Patients with a diagnosed milk allergy. 3.Patients whom the principal investigator or sub-investigator judges to be unsuitable for participation. 4.Patients who have taken >-300 mg of lactoferrin daily for at least 1 week or >-2.5 g of Kestose daily for at least 1 week within the 30 days prior to primary registration. 5.Patients who have received antibacterial treatment within the 30 days prior to primary registration. At Secondary Registration 1.Patients whom the principal investigator or sub-investigator judges to be unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Nugent Score on Days 29 of Administration Compared to Day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Presence or absence of hypersensitivity | — |
Contacts
Public ContactMayuko Ichikawa
Nara Medical University Hospital
Outcome results
None listed