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

NCT06429358 | Completed DMC

• 1 other identifier: 3388
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (5)

• Urinary Detailed Report Values

  The test was performed to determine levels of neutrophils

  second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.

• Urine Culture

  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

  second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.

• Leukocytes:

  leukocytes in urine were evaluated

  second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.

• Nitrites:

  presence of nitrites in urine before and after intervention was investigated

  second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.

• pH

  Urinary pH values were measured

  second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.

Study Arms (2)

Probiotic Group

EXPERIMENTAL

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

Dietary Supplement: Lactobacillus rhamnosus

Control Group

OTHER

Other: Control Group

Interventions

Lactobacillus rhamnosus DIETARY_SUPPLEMENT

The probiotic supplement was delivered in the form of easy-to-swallow capsules.

Probiotic Group

Control Group OTHER

Participants in the control group were given a placebo that looked, tasted, and felt just like the probiotic pill.

Control Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: 14 week's gestation with diagnosed UTI
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Frontier Medical and Dental College, Abbotabad: lead

Study Sites (1)

Frontier Medical and Dental College

Abbottābād, KPK, Pakistan

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 28, 2024
• Study Start: June 23, 2023
• Primary Completion: November 14, 2023
• Study Completion: January 15, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)