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| Name | Class |
|---|---|
| BioGaia AB | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | 5*10^8 CFU of Lactobacillus reuteri DSM 16666/ATCC 55845 & Lactobacillus reuteri DSM 17938, PAC-A and Zinc |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | Rate of recurrence cases during the rest of pregnancy | 6 months |
| Time to relapse | Time occurred since the finish of treatment until new UTI occurred |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Dr. Manuel Gea Gonzalez | Mexico City | Tlalpan | 14080 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12848475 | Result | 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. | |
| 22010614 | Result | Colgan R, Williams M. Diagnosis and treatment of acute uncomplicated cystitis. Am Fam Physician. 2011 Oct 1;84(7):771-6. |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Randomized controlled trial, double blind allocation concealment, parallel Assignment
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Randomization list will by assembled by independient organization not related with participant, care provider, investigators or sponsors. eCRF will include randomization selection
|
| 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 |
|
| 6 months |
| Frequency of pyelonephritis | Number of cases of pyelonephritis in each branch | 6 months |
| Frequency of preterm babies | Number of children at delivery with <36wekks of gestation | 6 months |
| Antibiotic rescue | Use of antibiotics for the treatment of pyelonephritis | 6 months |
| Adverse events | Frequency of adverse events in each branch | 14 days |
| 21888302 | 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. |
| 21292654 | 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. |
| 26255208 | 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. |
| 2927852 | 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. |
| 27590374 | 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. |
| D019602 |
| Food and Beverages |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |