Urinary Tract InfectionsNCT06429358
The Role of Probiotics in Preventing Recurrent Urinary Tract Infections in Pregnant Women
A study testing Lactobacillus rhamnosus in people with Urinary Tract Infections, run by Frontier Medical and Dental College, Abbotabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Lactobacillus rhamnosus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Jun 2023to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women aged 18-40 year
- History of recurrent urinary tract infections (two or more episodes in the past year).
- Singleton pregnancy.
Who cannot join
- Multiple gestations.
- History of preterm labor.
- Chronic medical conditions (e.g., diabetes mellitus, immunodeficiency disorders).
- Use of antibiotics or probiotics within the past month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Probiotics in Preventing Recurrent Urinary Tract Infections in Pregnant Women: A Randomized Control Trial
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
- Being tested
- Lactobacillus rhamnosus, Control Group
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosusDietary supplement
The probiotic supplement was delivered in the form of easy-to-swallow capsules.
Control GroupOther
Participants in the control group were given a placebo that looked, tasted, and felt just like the probiotic pill.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group | Experimental | The probiotic group received a daily oral supplement with Lactobacillus rhamnosus. The probiotic supplement was delivered as easy-to-swallow capsules. Receives: Dietary Supplement: Lactobacillus rhamnosus |
| Control Group | Other | Not described Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Detailed Report Values
The test was performed to determine levels of neutrophils
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start23 Jun 2023
- Primary completion14 Nov 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frontier Medical and Dental College, Abbotabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Saif ur Rehman, Frontier Medical and Dental College, Abbotabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429358
- Sponsor's protocol ID
- 3388
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Probiotics in Preventing Recurrent Urinary Tract Infections in Pregnant Women: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06429358
- Acronym / sponsor ID
- 3388
- Conditions
- Urinary Tract Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Frontier Medical and Dental College, AbbotabadUniversity, hospital or other
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Experimental | Dietary Supplement: Lactobacillus rhamnosusThe probiotic group received a daily oral supplement with Lactobacillus rhamnosus. The probiotic supplement was delivered as easy-to-swallow capsules. |
| Control Group | Other | Other: Control Group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women aged 18-40 year
- History of recurrent urinary tract infections (two or more episodes in the past year).
- Singleton pregnancy.
Key exclusion criteria (4 listed)
- Multiple gestations.
- History of preterm labor.
- Chronic medical conditions (e.g., diabetes mellitus, immunodeficiency disorders).
- Use of antibiotics or probiotics within the past month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus rhamnosusThe probiotic supplement was delivered in the form of easy-to-swallow capsules. | Dietary supplement | Probiotic Group |
| Control GroupParticipants in the control group were given a placebo that looked, tasted, and felt just like the probiotic pill. | Other | Control Group |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus rhamnosus in people with Urinary Tract Infections, run by Frontier Medical and Dental College, Abbotabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.