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Clinical Trials/NCT06429358
NCT06429358
Completed
Not Applicable

The Role of Probiotics in Preventing Recurrent Urinary Tract Infections in Pregnant Women: A Randomized Control Trial

Frontier Medical and Dental College, Abbotabad1 site in 1 country30 target enrollmentJune 23, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Tract Infections
Sponsor
Frontier Medical and Dental College, Abbotabad
Enrollment
30
Locations
1
Primary Endpoint
Urinary Detailed Report Values
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 23, 2023
End Date
January 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Frontier Medical and Dental College, Abbotabad
Responsible Party
Principal Investigator
Principal Investigator

Dr Saif ur Rehman

Professor

Frontier Medical and Dental College, Abbotabad

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Urinary Detailed Report Values

Time Frame: 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

Time Frame: 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

Time Frame: 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:

Time Frame: 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:

Time Frame: 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

Study Sites (1)

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