The Role of Probiotics in Preventing Recurrent Urinary Tract Infections in Pregnant Women

Not Applicable

Completed

• Conditions: Urinary Tract Infections
• Interventions: Dietary Supplement: Lactobacillus rhamnosus; Other: Control Group

• Registration Number: NCT06429358
• Lead Sponsor: Frontier Medical and Dental College, Abbotabad

Brief Summary

Urinary tract infections (UTIs) are a significant public health problem affecting more than 150 million people worldwide and causing a significant economic impact of approximately US$ 6 billion annually. It is one of the most common infectious diseases after upper respiratory tract infections. More than 50% of women and at least 12% of men will be affected by urinary tract infections in their lifetime. The probiotic supplement was delivered as easy-to-swallow capsules specifically prepared to maintain the viability and stability of the Lactobacillus rhamnosus GG strain throughout the research period. Participants were told to take the probiotic supplement with water to maximise absorption and efficiency, ideally after meals.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-23
• Primary Completion: 2023-11-14
• Study Completion: 2024-01-15
• Status Verified: 2024-05
• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-05-23
• Last Update Submitted: 2024-05-23
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Pregnant women aged 18-40 year
• History of recurrent urinary tract infections (two or more episodes in the past year).
• Singleton pregnancy.

Exclusion Criteria

• Multiple gestations.
• History of preterm labor.
• Chronic medical conditions (e.g., diabetes mellitus, immunodeficiency disorders).
• Use of antibiotics or probiotics within the past month.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic Group	Lactobacillus rhamnosus	The probiotic group received a daily oral supplement with Lactobacillus rhamnosus. The probiotic supplement was delivered as easy-to-swallow capsules.
Control Group	Control Group	-

Primary Outcome Measures

Name	Time	Method
Urinary Detailed Report Values	second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.	The test was performed to determine levels of neutrophils
pH	second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.	Urinary pH values were measured
Urine Culture	second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.	Urine Culture: Urine samples were collected aseptically prior to and after intervention and cultured to detect bacterial pathogens linked with urinary tract infections. This assessment was carried out at two distinct time points: Pre-Intervention: Before beginning the probiotic intervention, baseline urine samples were taken to detect any existing bacterial illnesses and create a point of comparison.; Post-Intervention: After the intervention period, individuals supplied an additional urine sample for culture investigation. This post-intervention evaluation sought to establish any changes in the prevalence of bacterial pathogens, particularly those known to cause urinary tract infection
Leukocytes:	second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.	leukocytes in urine were evaluated
Nitrites:	second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.	presence of nitrites in urine before and after intervention was investigated

Trial Locations

Locations (1)

Frontier Medical and Dental College; 🇵🇰 Abbottābād, KPK, Pakistan