Ignite Creation Date:
2024-05-06 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03362697
Status:
COMPLETED
Last Update Posted:
2019-06-20
First Post:
2017-11-28
Brief Title:
Lactobacillus Reuteri for Treatment of Uncomplicated UTI in Pregnant Women
Sponsor:
Innovacion y Desarrollo de Estrategias en Salud
Organization:
Innovacion y Desarrollo de Estrategias en Salud
Study Overview
Official Title:
Randomized Clinical Trial on the Safety and Efficacy of Lactobacillus Reuteri DSM 16666ATCC 55845 Lactobacillus Reuteri DSM 17938 for Treatment of Pregnant Women With Asymptomatic Bacteriuria or Uncomplicated Acute Cystitis
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UTIPregnant
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 preventiontreatment 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
Detailed Description:
Randomized controlled trial aimed to evaluate the efficacy of Lactobacillus reuteri DSM 16666ATCC 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 5108 CFU of Lactobacillus reuteri DSM 16666ATCC 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None