Role of Oral Lactoferrin in Prevention of Recurnt Bacterial Vaginosis in Pregnancy

Phase 2

Recruiting

• Conditions: Bacterial Vaginosis | Vaginal | Microbiology
• Interventions: Drug: lactoferrin

• Registration Number: NCT05669963
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2022-12
• Study First Submitted: 2022-12-20
• Study First Submitted QC: 2022-12-20
• Last Update Submitted: 2022-12-20
• Primary Completion: 2023-01
• Study Completion: 2023-01
• Study First Posted: 2023-01-03
• Last Update Posted: 2023-01-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 66

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	lactoferrin	not recieving lactoferrin
study group	lactoferrin	study group 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). During follow-up period, all women ingested 1 capsule of lactoferrin or placebo per day, for 10 consecutive days per month.

Primary Outcome Measures

Name	Time	Method
clinical cure rate of bacterial vaginosis symptoms	3 months	clinical cure rate of bacterial vaginosis symptoms (defined as absence of vaginal discharge or itching)
microbiological cure rate of bacterial vaginosis	3 months	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)
recurrence rate of bacterial vaginosis	3 months	recurrence of bacterial vaginosis symptoms

Trial Locations

Locations (1)

Rania Samy ezzat; 🇪🇬 Zagazig, Sharqia, Egypt