Urinary Tract Infections (UTIs)NCT02637986
The Efficacy of Orally Administrated Probiotic Formula in Preventing a Recurrence of a Urinary Tract Infection During Pregnancy
A study testing Urex Plus - containing L. rhamnosus GR-1 and L. reuteri RC-14 in people with Urinary Tract Infections (UTIs), run by HaEmek Medical Center, Israel.
Trial summary
Background: Urinary tract infections (UTIs), the most common infection in pregnancy,are associated with several maternal and fetal complications, including maternal septic shock, preterm labor, intrauterine growth restriction and intrauterine fetal death. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infections (UTIs)
- What is being tested?
- Urex Plus - containing L. rhamnosus GR-1 and L. reuteri RC-14
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 7 Nov 2022to 7 Nov 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 18 years old
- Pregnant women who suffered from at least one episode of UTI
- Women less than 34th week of gestation at the time of the enrollment
- Urine culture is sterile in the beginning of the study
Who cannot join
- Immunocompromised women
About this study
Official title: The Efficacy of Orally Administrated Probiotic Formula in Preventing a Recurrence of a Urinary Tract Infection During Pregnancy - a Prospective Randomized Double Blind Placebo-control Study
Background: Urinary tract infections (UTIs), the most common infection in pregnancy,are associated with several maternal and fetal complications, including maternal septic shock, preterm labor, intrauterine growth restriction and intrauterine fetal death. Thus, the prevention of UTIs in pregnancy is a very important goal. Several studies have suggested that alterations in the vaginal flora were associated with recurrent UTIs, and probiotic administrations may have a role in preventing those infections. Nevertheless, this has never been tested in pregnant women.
Read the detailed description
Background: Urinary tract infections (UTIs), the most common infection in pregnancy,are associated with several maternal and fetal complications, including maternal septic shock, preterm labor, intrauterine growth restriction and intrauterine fetal death. Thus, the prevention of UTIs in pregnancy is a very important goal. Several studies have suggested that alterations in the vaginal flora were associated with recurrent UTIs, and probiotic administrations may have a role in preventing those infections. Nevertheless, this has never been tested in pregnant women.
Working hypothesis and aims:Administration of oral probiotic formula to pregnant women,which suffered from at least one episode of UTI, will reduce the recurrence of future UTIs events.
Methods: A prospective randomized double blind placebo-control study. Pregnant women which suffered from at least one event of UTI during pregnancy will be divided into 2 research arms:
ARM A - women who suffered from one episode of UTI during pregnancy before recruitment: after antibiotic treatment achieving a sterile bacterial urine culture, these patients will be divided into a research group which will receive the probiotic formula Urex Plus containing L. rhamnosus GR-1 and L. reuteri RC-14, and a control group, which will receive a placebo, twice a day until delivery.
ARM B - women who suffered from more than one episode of UTI or one episode of pyelonephritis during pregnancy before recruitment will receive a preventive antibiotic treatment until delivery. Similarly to ARM A, after achieving a sterile bacterial urine culture, those women, will be divided into a research group, which will receive the probiotic formula Urex Plus, and a control group, which will receive a placebo twice a day until delivery.
Once a month and with symptoms, urine culture will be taken in all of the study arms. Vaginal swab test will also be taken to detect the presence of abnormal vaginal flora and semi-quantitative assessment of vaginal lactobacilli.
Data regarding the rate of recurrent UTIs, time until infection, average number of infections, the rate of pyelonephritis infections and obstetrical and neonatal outcomes will be collected.
- Conditions
- Urinary Tract Infections (UTIs)
- Being tested
- Urex Plus - containing L. rhamnosus GR-1 and L. reuteri RC-14, Placebo - capsule with no active ingredient
- 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.
Urex Plus - containing L. rhamnosus GR-1 and L. reuteri RC-14Dietary supplement
2 capsules will be given per day
Placebo - capsule with no active ingredientOther
2 capsules will be given per day
| Study group | Role | What they receive |
|---|---|---|
| ARM A - suffered from one episode of UTI | Experimental | Women who suffered from one episode of UTI during pregnancy before recruitment Receives: Dietary Supplement: Urex Plus - containing L. rhamnosus GR-1 and L. reuteri RC-14 |
| ARM A - suffered from one episode of UTI - placebo | Placebo comparator | Women who suffered from one episode of UTI during pregnancy before recruitment Receives: Other: Placebo - capsule with no active ingredient |
| ARM B -suffered from more than one episode of UTI | Experimental | women who suffered from more than one episode of UTI or one episode of pyelonephritis during pregnancy before recruitment Receives: Dietary Supplement: Urex Plus - containing L. rhamnosus GR-1 and L. reuteri RC-14 |
| ARM B -suffered from more than one episode of UTI - placebo | Placebo comparator | women who suffered from more than one episode of UTI or one episode of pyelonephritis during pregnancy before recruitment Receives: Other: Placebo - capsule with no active ingredient |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of women who developed UTI after receiving probiotic formula versus placebo.
The rate of women who developed UTI after receiving probiotic formula versus placebo.
Measured: 1 year
Secondary outcomes (5)
Duration of time from the beginning of study until an episode of UTI.
Measured: 1 year
The number of UTIs during pregnancy.
Measured: 1 year
The rate of women who suffer from bacteruria, cystitis and pyelonephritis.
Measured: 1 year
The rate of women who suffer from obstetrical outcomes (preterm labor, intrauterine growth restriction).
Measured: 1 year
Adverse effects of the probiotic capsules versus placebo
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study start7 Nov 2022
- Primary completion7 Nov 2022
- Study completion7 Nov 2022
Why it stopped: The investigatore decided not to proceed with this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infections (UTIs)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enav Yefet, MD/PhD, Principal investigator, Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637986
- Sponsor's protocol ID
- 0173-13-EMC
- Status last verified
- Nov 2022
- First submitted
- 16 Dec 2015
- Last updated
- 8 Nov 2022
- Results posted
- No
- 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 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Orally Administrated Probiotic Formula in Preventing a Recurrence of a Urinary Tract Infection During Pregnancy - a Prospective Randomized Double Blind Placebo-control Study
- ClinicalTrials.gov ID
- NCT02637986
- Acronym / sponsor ID
- 0173-13-EMC
- Conditions
- Urinary Tract Infections (UTIs)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The investigatore decided not to proceed with this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 22 Dec 2015 (estimated)
- 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.
Background: Urinary tract infections (UTIs), the most common infection in pregnancy,are associated with several maternal and fetal complications, including maternal septic shock, preterm labor, intrauterine growth restriction and intrauterine fetal death. Thus, the prevention of UTIs in pregnancy is a very important goal. Several studies have suggested that alterations in the vaginal flora were associated with recurrent UTIs, and probiotic administrations may have a role in preventing those infections. Nevertheless, this has never been tested in pregnant women.
Detailed description
Background: Urinary tract infections (UTIs), the most common infection in pregnancy,are associated with several maternal and fetal complications, including maternal septic shock, preterm labor, intrauterine growth restriction and intrauterine fetal death. Thus, the prevention of UTIs in pregnancy is a very important goal. Several studies have suggested that alterations in the vaginal flora were associated with recurrent UTIs, and probiotic administrations may have a role in preventing those infections. Nevertheless, this has never been tested in pregnant women.
Working hypothesis and aims:Administration of oral probiotic formula to pregnant women,which suffered from at least one episode of UTI, will reduce the recurrence of future UTIs events.
Methods: A prospective randomized double blind placebo-control study. Pregnant women which suffered from at least one event of UTI during pregnancy will be divided into 2 research arms:
ARM A - women who suffered from one episode of UTI during pregnancy before recruitment: after antibiotic treatment achieving a sterile bacterial urine culture, these patients will be divided into a research group which will receive the probiotic formula Urex Plus containing L. rhamnosus GR-1 and L. reuteri RC-14, and a control group, which will receive a placebo, twice a day until delivery.
ARM B - women who suffered from more than one episode of UTI or one episode of pyelonephritis during pregnancy before recruitment will receive a preventive antibiotic treatment until delivery. Similarly to ARM A, after achieving a sterile bacterial urine culture, those women, will be divided into a research group, which will receive the probiotic formula Urex Plus, and a control group, which will receive a placebo twice a day until delivery.
Once a month and with symptoms, urine culture will be taken in all of the study arms. Vaginal swab test will also be taken to detect the presence of abnormal vaginal flora and semi-quantitative assessment of vaginal lactobacilli.
Data regarding the rate of recurrent UTIs, time until infection, average number of infections, the rate of pyelonephritis infections and obstetrical and neonatal outcomes will be collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ARM A - suffered from one episode of UTI | Experimental | Dietary Supplement: Urex Plus - containing L. rhamnosus GR-1 and L. reuteri RC-14Women who suffered from one episode of UTI during pregnancy before recruitment |
| ARM A - suffered from one episode of UTI - placebo | Placebo comparator | Other: Placebo - capsule with no active ingredientWomen who suffered from one episode of UTI during pregnancy before recruitment |
| ARM B -suffered from more than one episode of UTI | Experimental | Dietary Supplement: Urex Plus - containing L. rhamnosus GR-1 and L. reuteri RC-14women who suffered from more than one episode of UTI or one episode of pyelonephritis during pregnancy before recruitment |
| ARM B -suffered from more than one episode of UTI - placebo | Placebo comparator | Other: Placebo - capsule with no active ingredientwomen who suffered from more than one episode of UTI or one episode of pyelonephritis during pregnancy before recruitment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Above 18 years old
- Pregnant women who suffered from at least one episode of UTI
- Women less than 34th week of gestation at the time of the enrollment
- Urine culture is sterile in the beginning of the study
Key exclusion criteria (1 listed)
- Immunocompromised women
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 |
|---|---|---|
| Urex Plus - containing L. rhamnosus GR-1 and L. reuteri RC-142 capsules will be given per day | Dietary supplement | ARM A - suffered from one episode of UTI, ARM B -suffered from more than one episode of UTI |
| Placebo - capsule with no active ingredient2 capsules will be given per day | Other | ARM A - suffered from one episode of UTI - placebo, ARM B -suffered from more than one episode of UTI - placebo |
Primary outcome
The rate of women who developed UTI after receiving probiotic formula versus placebo.
Time frame: 1 year
The rate of women who developed UTI after receiving probiotic formula versus placebo.
5 secondary outcomes
Duration of time from the beginning of study until an episode of UTI.
Time frame: 1 year
The number of UTIs during pregnancy.
Time frame: 1 year
The rate of women who suffer from bacteruria, cystitis and pyelonephritis.
Time frame: 1 year
The rate of women who suffer from obstetrical outcomes (preterm labor, intrauterine growth restriction).
Time frame: 1 year
Adverse effects of the probiotic capsules versus placebo
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- 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.
Enav Yefet, MD/PhD principal investigator
Emek Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Urex Plus - containing L. rhamnosus GR-1 and L. reuteri RC-14 in people with Urinary Tract Infections (UTIs), run by HaEmek Medical Center, Israel.
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 4 inclusion and 1 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: withdrawn, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
The rate of women who developed UTI after receiving probiotic formula versus placebo. (time frame: 1 year). 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 8 Nov 2022.