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Urinary Tract Infection in PregnancyUTIPregnantNCT03362697

Lactobacillus Reuteri for Treatment of Uncomplicated UTI in Pregnant Women

A study testing Probiotics and Antibiotics in people with Urinary Tract Infection in Pregnancy, run by Innovacion y Desarrollo de Estrategias en Salud at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prevalence of uro-genital infections during pregnancy move between 7% to 12% in developed countries, meanwhile in developing countries this figure moved between 14% and until 55%, such is the case of Mexico. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Urinary Tract Infection in Pregnancy
What is being tested?
Probiotics and Antibiotics
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteMexico
Study dates
15 Dec 2017to 18 Jun 2019
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

  • Healthy women on the second or third trimester of pregnancy with positive urine culture according to the operational definition with or without symptoms
  • Age 18 to 40 years
  • Verbal and Written Informed Consent for participation in the study

Who cannot join

  • Pathologic pregnancy (different for UTI)
  • No supplementation of probiotics 2 weeks before study start or during the study period.
  • Antibiotic therapy within last 2 weeks before randomization
  • Known allergies towards the ingredients of the experimental product
  • Inability to comprehend the study protocol
  • Systemic diseases
  • Multiple pregnancy

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Hospital General Dr. Manuel Gea Gonzalez

    Mexico City, Tlalpan, 14080

Other trials in Mexico

About this study

Official title: Randomized Clinical Trial on the Safety and Efficacy of Lactobacillus Reuteri DSM 16666/ATCC 55845 & Lactobacillus Reuteri DSM 17938 for Treatment of Pregnant Women With Asymptomatic Bacteriuria or Uncomplicated Acute Cystitis

Prevalence of uro-genital infections during pregnancy move between 7% to 12% in developed countries, meanwhile in developing countries this figure moved between 14% and until 55%, such is the case of Mexico. Meanwhile use of antibiotics for 3 to 7 days had established as a standard of care, the use of non-antibiotic therapy, such as cranberry powder or probiotics for prevention/treatment of this conditions is scarce. Randomized controlled trial aimed to evaluate the safety and efficacy of probiotic vs. antibiotics to treat pregnant women with uncomplicated cystitis or asymptomatic bacteriuria

Read the detailed description

Randomized controlled trial, aimed to evaluate the efficacy of Lactobacillus reuteri DSM 16666/ATCC 55845 \& Lactobacillus reuteri DSM 17938 for the treatment of pregnant women with asymptomatic bacteriuria or uncomplicated acute cystitis. As primary outcome we will evaluate the number of cases with clinical (symptoms severity) or bacteriological cure in pregnant women with uncomplicated cystitis or asymptomatic bacteriuria after 7 days treatment with probiotics vs. placebo. As secondary outcome we will evaluate a) rate of recurrence cases in each group; b) time to relapse; c) frequency of pyelonephritis; d) birth weight and head circumference; d) number of cases of preterm babies (less than 36 weeks of gestation); e) frequency of antibiotic as rescue treatment; f) frequency of adverse related events in each arm and g) frequency of preeclampsia. Women on active group will receive a combination of at least 5*10^8 CFU of Lactobacillus reuteri DSM 16666/ATCC 55845 \& Lactobacillus reuteri DSM 17938, PAC-A and Zinc. Women in control group will receive o Amoxicillin + clavulanic acid (500 mg twice daily) for seven days in patients with negative nitrites in dipstick or oral nitrofurantoin (200mg twice per day) ror patients with positive dipstick.

Being tested
Probiotics, Antibiotics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProbioticsDietary supplement

    The Probiotic group will receive Sachet 1 - contains an instant cranberry drink, consisting of xylitol, monosodium citrate, cranberry aroma, cranberry extract, grape-skin extract, xanthan gum, acesulfame potassium and zinc gluconate and Sachet 2 - contains a total of 5*10^8 CFU of Lactobacillus reuteri DSM 16666/ATCC 55845 \& Lactobacillus reuteri DSM 17938, mixed with maltodextrin. Both Sachets should be administered Day 1-14, twice per day This group will also receive for Placebo for Antibiotic treatment day 1-7, twice per day

  • AntibioticsDrug

    Patient in this group will receive for 7 days Amoxicillin + clavulanic acid (500 mg twice daily) for seven days in patients with negative nitrites in dipstick or oral nitrofurantoin (200mg twice per day) for patients with positive nitrates in dipstick. This group will also receive for placebo for probiotics 2 sachets for 14 days

Study groups in NCT03362697
Study groupRoleWhat they receive
ProbioticExperimental5*10^8 CFU of Lactobacillus reuteri DSM 16666/ATCC 55845 \& Lactobacillus reuteri DSM 17938, PAC-A and Zinc
Receives: Dietary Supplement: Probiotics
AntibioticActive comparatorAmoxicillin + clavulanic acid (500 mg twice daily) for seven days in patients with negative nitrites in dipstick or oral nitrofurantoin (200mg twice per day) for patients with positive nitrates in dipstick
Receives: Drug: Antibiotics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical and/or Bacteriological cure

    Number of cases with improvement of symptoms severity and/or urinary culture during the first seven days of treatment

    Measured: 14 days

Secondary outcomes (6)

  1. Recurrence rate

    Rate of recurrence cases during the rest of pregnancy

    Measured: 6 months

  2. Time to relapse

    Time occurred since the finish of treatment until new UTI occurred

    Measured: 6 months

  3. Frequency of pyelonephritis

    Number of cases of pyelonephritis in each branch

    Measured: 6 months

  4. Frequency of preterm babies

    Number of children at delivery with <36wekks of gestation

    Measured: 6 months

  5. Antibiotic rescue

    Use of antibiotics for the treatment of pyelonephritis

    Measured: 6 months

  6. Adverse events

    Frequency of adverse events in each branch

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2017
  2. Study start15 Dec 2017
  3. Primary completion30 Dec 2018
  4. Study completion18 Jun 2019

Resources

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
Randomized controlled trial, double blind allocation concealment, parallel Assignment
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03362697
Sponsor's protocol ID
CSUB 0139
Acronym
UTIPregnant
Status last verified
Jun 2019
First submitted
28 Nov 2017
Last updated
20 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nicolle LE. Asymptomatic bacteriuria: when to screen and when to treat. Infect Dis Clin North Am. 2003 Jun;17(2):367-94. doi: 10.1016/s0891-5520(03)00008-4.

    PubMed 12848475

  • Colgan R, Williams M. Diagnosis and treatment of acute uncomplicated cystitis. Am Fam Physician. 2011 Oct 1;84(7):771-6.

    PubMed 22010614

  • Colgan R, Williams M, Johnson JR. Diagnosis and treatment of acute pyelonephritis in women. Am Fam Physician. 2011 Sep 1;84(5):519-26.

    PubMed 21888302

  • Gupta K, Hooton TM, Naber KG, Wullt B, Colgan R, Miller LG, Moran GJ, Nicolle LE, Raz R, Schaeffer AJ, Soper DE; Infectious Diseases Society of America; European Society for Microbiology and Infectious Diseases. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: A 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011 Mar 1;52(5):e103-20. doi: 10.1093/cid/ciq257.

    PubMed 21292654

  • Kazemier BM, Koningstein FN, Schneeberger C, Ott A, Bossuyt PM, de Miranda E, Vogelvang TE, Verhoeven CJ, Langenveld J, Woiski M, Oudijk MA, van der Ven JE, Vlegels MT, Kuiper PN, Feiertag N, Pajkrt E, de Groot CJ, Mol BW, Geerlings SE. Maternal and neonatal consequences of treated and untreated asymptomatic bacteriuria in pregnancy: a prospective cohort study with an embedded randomised controlled trial. Lancet Infect Dis. 2015 Nov;15(11):1324-33. doi: 10.1016/S1473-3099(15)00070-5. Epub 2015 Aug 5.

    PubMed 26255208

  • Romero R, Oyarzun E, Mazor M, Sirtori M, Hobbins JC, Bracken M. Meta-analysis of the relationship between asymptomatic bacteriuria and preterm delivery/low birth weight. Obstet Gynecol. 1989 Apr;73(4):576-82.

    PubMed 2927852

  • Ho M, Chang YY, Chang WC, Lin HC, Wang MH, Lin WC, Chiu TH. Oral Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 to reduce Group B Streptococcus colonization in pregnant women: A randomized controlled trial. Taiwan J Obstet Gynecol. 2016 Aug;55(4):515-8. doi: 10.1016/j.tjog.2016.06.003.

    PubMed 27590374

Questions about this trial

What is this clinical trial studying?

A study testing Probiotics and Antibiotics in people with Urinary Tract Infection in Pregnancy, run by Innovacion y Desarrollo de Estrategias en Salud at 1 site in Mexico.

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 7 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 20 Jun 2019. 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 Mexico. 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?

Clinical and/or Bacteriological cure (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03362697, which also lists 7 linked publications.

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 20 Jun 2019.

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