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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bacterial Vaginosis | Vaginal | Microbiology
• Intervention / Treatment: Drug: lactoferrin

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 Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Rania Samy Ezzat, MD; Phone Number: +201006109904; Email: rsezzat@medicine.zu.edu.eg
• Study Contact Backup: Name: Khawla Almahdi, MBBCH; Phone Number: 00201020427536

Study Locations

• Egypt
  • Sharqia
    • Zagazig, Sharqia, Egypt, 00000
      • Recruiting
      • Rania Samy ezzat
      • Contact: Rania Samy ezzat; Phone Number: 01006109904; Email: rsezzat@medicine.zu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 37 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: study group; 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.	Drug: lactoferrin; 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.(pravotin). 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.; Other Names: PRAVOTIN
Placebo Comparator: control group; not recieving lactoferrin	Drug: lactoferrin; 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.(pravotin). 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.; Other Names: PRAVOTIN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical cure rate of bacterial vaginosis symptoms	clinical cure rate of bacterial vaginosis symptoms (defined as absence of vaginal discharge or itching)	3 months
microbiological cure rate of bacterial vaginosis	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)	3 months
recurrence rate of bacterial vaginosis	recurrence of bacterial vaginosis symptoms	3 months

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Study Director: Rania Samy Ezzat, MD, Lecturer of obstetrics and Gynecology, Faculty of Medicine, Zagazig University; Study Chair: Amal Mohamed Alanwar, MD, Professor of obstetrics and Gynecology, Faculty of Medicine, Zagazig University; Study Director: Safaa Abdelsalam Ibrahim, MD, Professor of obstetrics and Gynecology, Faculty of Medicine, Zagazig University; Study Director: Marian Asaad Gerges, MD, Assistant Professor of Microbiology and Immunology Faculty of Medicine Zagazig University; Principal Investigator: Khoulh Al Mahdi Anbeeh Al Barhami, MBBCH, Master's degree candidate

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): January 3, 2023

Study Record Updates

• Last Update Posted (Actual): January 3, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Vaginosis, Bacterial; Anti-Infective Agents; Lactoferrin
• Other Study ID Numbers: ZU-IRB #9639/5-7-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No