Lactobacillus Reuteri for Treatment of Uncomplicated UTI in Pregnant Women

Urinary Tract Infection in Pregnancy Clinical Trial

— UTIPregnant  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03362697
• Other study ID #: CSUB 0139
• Status: Completed
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: June 18, 2019

Study information

• Verified date: June 2019
• Source: Innovacion y Desarrollo de Estrategias en Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 18, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Urinary Tract Infection in Pregnancy
• Urinary Tract Infections

Intervention

Dietary Supplement:
• Probiotics
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

Drug:
• Antibiotics
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

Locations

Country	Name	City	State
Mexico	Hospital General Dr. Manuel Gea Gonzalez	Mexico city	Tlalpan

Sponsors (2)

Lead Sponsor	Collaborator
Innovacion y Desarrollo de Estrategias en Salud	BioGaia AB

Country where clinical trial is conducted

Mexico, 

References & Publications (7)

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

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

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 — View Citation

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; — View Citation

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 neona — View Citation

Nicolle LE. Asymptomatic bacteriuria: when to screen and when to treat. Infect Dis Clin North Am. 2003 Jun;17(2):367-94. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and/or Bacteriological cure	Number of cases with improvement of symptoms severity and/or urinary culture during the first seven days of treatment	14 days
Secondary	Recurrence rate	Rate of recurrence cases during the rest of pregnancy	6 months
Secondary	Time to relapse	Time occurred since the finish of treatment until new UTI occurred	6 months
Secondary	Frequency of pyelonephritis	Number of cases of pyelonephritis in each branch	6 months
Secondary	Frequency of preterm babies	Number of children at delivery with <36wekks of gestation	6 months
Secondary	Antibiotic rescue	Use of antibiotics for the treatment of pyelonephritis	6 months
Secondary	Adverse events	Frequency of adverse events in each branch	14 days