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

NCT05669963 | Unknown Phase 2

• 1 other identifier: ZU-IRB #9639/5-7-2022
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Vaginosis | Vaginal | Microbiology

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

study group

ACTIVE COMPARATOR

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

control group

PLACEBO COMPARATOR

not recieving lactoferrin

Drug: lactoferrin

Interventions

lactoferrin 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.

Also known as: PRAVOTIN

control group; study group

Eligibility Criteria

• Age: 20 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women of age group 20-37 years.
• Primigravida.
• week gestation.
• History of receurent bacterial vaginosis .

You may not qualify if:

• Multiple gestations.
• Multiparity.
• Medical disorders as:
• Diabetes mellitus.
• Chronic hypertension.
• Endocrinal diseases.
• Autoimmune diseases.
• Renal diseases.
• Blood diseases.
• Allergy to lactoferrin .

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Rania Samy ezzat

Zagazig, Sharqia Province, 00000, Egypt

RECRUITING

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Lactoferrin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Officials

• Rania Samy Ezzat, MD

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

  STUDY DIRECTOR

• Amal Mohamed Alanwar, MD

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

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• Khoulh Al Mahdi Anbeeh Al Barhami, MBBCH

  Master's degree candidate

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rania Samy Ezzat, MD

CONTACT

+201006109904; rsezzat@medicine.zu.edu.eg

Khawla Almahdi, MBBCH

CONTACT

00201020427536

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 3, 2023
• Study Start: July 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: January 3, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)