Lactobacillus Reuteri for Treatment of Uncomplicated UTI in Pregnant Women

NCT03362697 | Completed DMC

• 1 other identifier: CSUB 0139
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Urinary Tract Infection in Pregnancy

Outcome Measures

Primary Outcomes (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

  14 days

Secondary Outcomes (6)

• Recurrence rate

  6 months

• Time to relapse

  6 months

• Frequency of pyelonephritis

  6 months

• Frequency of preterm babies

  6 months

• Antibiotic rescue

  6 months

Study Arms (2)

Probiotic

EXPERIMENTAL

5\*10\^8 CFU of Lactobacillus reuteri DSM 16666/ATCC 55845 \& Lactobacillus reuteri DSM 17938, PAC-A and Zinc

Dietary Supplement: Probiotics

Antibiotic

ACTIVE COMPARATOR

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

Drug: Antibiotics

Interventions

Probiotics DIETARY_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

Probiotic

Antibiotics DRUG

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

Antibiotic

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Innovacion y Desarrollo de Estrategias en Salud: lead
• BioGaia AB: collaborator

Study Sites (1)

Hospital General Dr. Manuel Gea Gonzalez

Mexico City, Tlalpan, 14080, Mexico

Location

Related Publications (7)

• 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.

  PMID: 12848475 RESULT

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

  PMID: 22010614 RESULT

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

  PMID: 21888302 RESULT

• 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.

  PMID: 21292654 RESULT

• 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.

  PMID: 26255208 RESULT

• 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.

  PMID: 2927852 RESULT

• 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.

  PMID: 27590374 RESULT

MeSH Terms

Interventions

Probiotics; Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization list will by assembled by independient organization not related with participant, care provider, investigators or sponsors. eCRF will include randomization selection
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research

Model Details: Randomized controlled trial, double blind allocation concealment, parallel Assignment

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 5, 2017
• Study Start: December 15, 2017
• Primary Completion: December 30, 2018
• Study Completion: June 18, 2019
• Last Updated: June 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)