NIPH Clinical Trials Search

CARE BV

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	bacterial vaginosis
Date of first enrollment	16/09/2025
Target sample size	40
Countries of recruitment
Study type	Interventional
Intervention(s)	Lactoferrin and Kestose Combination Product Usage

Outcome(s)

Primary Outcome	Change in Nugent Score on Days 29 of Administration Compared to Day 1
Secondary Outcome	Presence or absence of hypersensitivity

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	< 47age old
Gender	Female
Include 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.
Exclude 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.