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

Primary Purpose

Bacterial Vaginosis | Vaginal | Microbiology

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
lactoferrin
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginosis | Vaginal | Microbiology

Eligibility Criteria

20 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Pregnant women of age group 20-37 years. Primigravida. 28-40 week gestation. History of receurent bacterial vaginosis . Exclusion Criteria: Multiple gestations. Multiparity. Medical disorders as: Diabetes mellitus. Chronic hypertension. Endocrinal diseases. Autoimmune diseases. Renal diseases. Blood diseases. Allergy to lactoferrin .

Sites / Locations

  • Rania Samy ezzatRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

study group

control group

Arm Description

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.

not recieving lactoferrin

Outcomes

Primary Outcome Measures

clinical cure rate of bacterial vaginosis symptoms
clinical cure rate of bacterial vaginosis symptoms (defined as absence of vaginal discharge or itching)
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)
recurrence rate of bacterial vaginosis
recurrence of bacterial vaginosis symptoms

Secondary Outcome Measures

Full Information

First Posted
December 20, 2022
Last Updated
December 20, 2022
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05669963
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis &#X7C; Vaginal &#X7C; Microbiology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
not recieving lactoferrin
Intervention Type
Drug
Intervention Name(s)
lactoferrin
Other Intervention Name(s)
PRAVOTIN
Intervention Description
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.
Primary Outcome Measure Information:
Title
clinical cure rate of bacterial vaginosis symptoms
Description
clinical cure rate of bacterial vaginosis symptoms (defined as absence of vaginal discharge or itching)
Time Frame
3 months
Title
microbiological cure rate of bacterial vaginosis
Description
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)
Time Frame
3 months
Title
recurrence rate of bacterial vaginosis
Description
recurrence of bacterial vaginosis symptoms
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant women of age group 20-37 years. Primigravida. 28-40 week gestation. History of receurent bacterial vaginosis . Exclusion Criteria: Multiple gestations. Multiparity. Medical disorders as: Diabetes mellitus. Chronic hypertension. Endocrinal diseases. Autoimmune diseases. Renal diseases. Blood diseases. Allergy to lactoferrin .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rania Samy Ezzat, MD
Phone
+201006109904
Email
rsezzat@medicine.zu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Khawla Almahdi, MBBCH
Phone
00201020427536
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rania Samy Ezzat, MD
Organizational Affiliation
Lecturer of obstetrics and Gynecology, Faculty of Medicine, Zagazig University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amal Mohamed Alanwar, MD
Organizational Affiliation
Professor of obstetrics and Gynecology, Faculty of Medicine, Zagazig University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Safaa Abdelsalam Ibrahim, MD
Organizational Affiliation
Professor of obstetrics and Gynecology, Faculty of Medicine, Zagazig University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marian Asaad Gerges, MD
Organizational Affiliation
Assistant Professor of Microbiology and Immunology Faculty of Medicine Zagazig University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Khoulh Al Mahdi Anbeeh Al Barhami, MBBCH
Organizational Affiliation
Master's degree candidate
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rania Samy ezzat
City
Zagazig
State/Province
Sharqia
ZIP/Postal Code
00000
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rania Samy ezzat
Phone
01006109904
Email
rsezzat@medicine.zu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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

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