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

NCT ID: NCT05669963

Last Updated: 2023-01-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-01-31

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.

Conditions

Bacterial Vaginosis &#X7C; Vaginal &#X7C; Microbiology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

lactoferrin

Intervention Type: DRUG

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.

control group

not recieving lactoferrin

Group Type: PLACEBO_COMPARATOR

lactoferrin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

PRAVOTIN

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 .

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Rania Samy Mohamed Ezzat

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rania Samy Ezzat, MD

Role: STUDY_DIRECTOR

Lecturer of obstetrics and Gynecology, Faculty of Medicine, Zagazig University

Amal Mohamed Alanwar, MD

Role: STUDY_CHAIR

Professor of obstetrics and Gynecology, Faculty of Medicine, Zagazig University

Safaa Abdelsalam Ibrahim, MD

Role: STUDY_DIRECTOR

Professor of obstetrics and Gynecology, Faculty of Medicine, Zagazig University

Marian Asaad Gerges, MD

Role: STUDY_DIRECTOR

Assistant Professor of Microbiology and Immunology Faculty of Medicine Zagazig University

Khoulh Al Mahdi Anbeeh Al Barhami, MBBCH

Role: PRINCIPAL_INVESTIGATOR

Master's degree candidate

Locations

Rania Samy ezzat

Zagazig, Sharqia Province, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Rania Samy Ezzat, MD

Role: CONTACT

rsezzat@medicine.zu.edu.eg

+201006109904

Khawla Almahdi, MBBCH

Role: CONTACT

00201020427536

Facility Contacts

Rania Samy ezzat

Role: primary

rsezzat@medicine.zu.edu.eg

01006109904

Other Identifiers

ZU-IRB #9639/5-7-2022

Identifier Type: -

Identifier Source: org_study_id