Clinical trial NCT05669963: Role of Oral Lactoferrin in Prevention of Recurnt Bacterial Vaginosis in Pregnancy
Official title: Role of Oral Lactoferrin in Prevention of Recurnt Bacterial Vaginosis in Third Trimester of Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Bacterial Vaginosis &#X7C; Vaginal &#X7C; Microbiology
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-01-03
Enrollment: 66
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assuming the cure rate was 70.8% vs 33.3% in intervention vs placebo group. At 80% power and 95 % CI, the estimated sample will be 66 cases, 33 cases in each group.
Primary purpose: TREATMENT

Brief summary: lactoferrin is believed to modulate immunity and help in prevention of recurrent bacterial vaginosis.In this study, the role of lactoferrin is assessed during third trimester of pregnancy.

Detailed description: This study will be conducted at Zagazig University Hospitals, Obestetrics and Gynecology department, Zagazig University ,outpatient clinic .Assuming the cure rate was 70.8% vs 33.3% in intervention vs placebo group. At 80% power and 95 % CI, the estimated sample will be 66 cases, 33 cases in each group.

Among enrolled women those who have symptome of bacterial vaginosis will be treated with standard antibiotic therapy (metronidazole 500 mg twice daily for 7 days) and women who have history of recurrent bacterial vaginosis randomly assigned to one of two study arms: study grop receiving lactoferrin (2 capsules/day for 5 days followed by further 10 consecutive days at the dosage of 1 capsule/day) by oral intake.(pravotinR).

And another group not reciving lactoferrin.(control group) During follow-up period, all women ingested 1 capsule of lactoferrin or placebo per day, for 10 consecutive days per month.(study group) .

- All participating women attended 3 visits (from T0 to T2) at the gynaecologic centres at recruitment (T0), swap will be repeated after one month (T1) and two months (T2). In each clinical examination, 2 vaginal swabs (for vaginal culture and Nugent score) will be collected. During the first visit (baseline), patient medical history was recorded, informed consent was signed and women were allocated into the two study arms. - The evaluation of efficacy is based on clinical cure rate of BV symptoms (defined as absence of vaginal discharge or itching), microbiological cure rate (defined as remission and vaginal microbiota improvement by restoration of healthy Nugent score with range 0-3), and overall cure rate (absence of symptoms and Nugent score \<7). In addition, recurrence rate was calculated for both groups as percentage of women presenting with symptoms and Nugent score more than 3 during the follow-up period. Safety is assessed by recording all side effects (i.e. adverse events, serious adverse events, and suspected unexpected serious adverse reactions). An adverse event is considered severe if it was fatal, life threatening, required hospitalisation, or led to permanent injury.

Eligibility criteria: Inclusion Criteria:

1. Pregnant women of age group 20-37 years.
2. Primigravida.
3. 28-40 week gestation.
4. History of receurent bacterial vaginosis .

Exclusion Criteria:

1. Multiple gestations.
2. Multiparity.
3. Medical disorders as:

   * Diabetes mellitus.
   * Chronic hypertension.
   * Endocrinal diseases.
   * Autoimmune diseases.
   * Renal diseases.
   * Blood diseases.
4. Allergy to lactoferrin .

Primary outcomes:
measure: clinical cure rate of bacterial vaginosis symptoms
timeFrame: 3 months
measure: microbiological cure rate of bacterial vaginosis
timeFrame: 3 months
measure: recurrence rate of bacterial vaginosis
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Rania Samy ezzat
state: Sharqia
Study officials:
affiliation: Lecturer of obstetrics and Gynecology, Faculty of Medicine, Zagazig University
name: Rania Samy Ezzat, MD
role: STUDY_DIRECTOR
affiliation: Professor of obstetrics and Gynecology, Faculty of Medicine, Zagazig University
name: Amal Mohamed Alanwar, MD
role: STUDY_CHAIR
affiliation: Professor of obstetrics and Gynecology, Faculty of Medicine, Zagazig University
name: Safaa Abdelsalam Ibrahim, MD
role: STUDY_DIRECTOR
affiliation: Assistant Professor of Microbiology and Immunology Faculty of Medicine Zagazig University
name: Marian Asaad Gerges, MD
role: STUDY_DIRECTOR
affiliation: Master's degree candidate
name: Khoulh Al Mahdi Anbeeh Al Barhami, MBBCH
role: PRINCIPAL_INVESTIGATOR
References: