Evaluation of the effect of probiotics on the prevention of bacterial biofilm formation on double J implanted in patients due to urological problems

Investigating the effect of probiotics on the prevention of bacterial biofilm formation on double J implanted in patients due to urological problems

Using the online site sealedenvelop.com (a site for sequencing randomized block), random blocks of patients in two groups A: double J plus placebo B: double J plus probiotic. The order of patient placement is provided to the technician. The study is Double blind (patient and researcher). 108 patients referred to Sina Hospital will be studied. The study is interventional, phase 3, parallel and therapeutic.

This clinical trial will be performed on 108 patients with kidney stone at Sina Hospital. urology research center, Tehran, Iran. The study will be double blind (Patient and researcher). Intervention group 1: Patients receiving double J with placebo. Intervention group 2: Patients receiving double J in addition to probiotic. Placebo capsule containing sugar, which is similar to probiotic capsule in terms of appearance and quantity, and both are prescribed one per day for 4 weeks.

Inclusion criteria: Consent to participate in the study, Candidate patients for double J implantation. Exclusion criteria: Anomalies of the genitourinary system, Patients who have residual stones after urinary system stone treatment, Single kidney patients, Treatment-resistant infections, Single kidney patients.

Intervention group A: Patients receiving double J with placebo. Intervention groupB: Patients receiving double J in addition to probiotic.

The bacterial biofilm formation on double j. Re-formation of stone on double J stent due to the presence of citrate probiotic and the absence of probiotic. Reduction of colonization on double J stent due to the use of probiotics

The present study is a double-blind randomized clinical trial. For randomization, the blanced block randomization method is used to generate quadruple blocks.According to the randomization method, we expect the two groups to differ by a maximum of 2 people in terms of the number of people assigned. After the methodologist prepares the randomization sequence using the sealdenvelop online site, the generated sequence will be made available to a technician outside the research team. Quadruple blocks (A or B) are placed in envelopes.After the arrival of the first patient with the inclusion criteria, the envelopes are randomly selected and the type of patient group is informed to the research team through a trained technician. Based on the randomly selected envelope, the patient is placed in the (A) double J plus placebo or (B) double J plus probiotic treatment group.

Patients who have agreed to participate in the study and the therapist for the blinding process, envelopes related to the type of intervention are provided only to the technician. The researcher (to avoid bias) and the patient are not informed of the type of intervention (double J plus placebo or double J plus probiotic). Placebo, a capsule containing sugar, which looks similar to a probiotic capsule, is prescribed for 4 weeks.

Demographic information anonymously

One year after publication

Researchers working in academia, physicians, surgeons and hospitals

Any analysis can be done with the consent of the main researcher

Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560

After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by the provision of a patient's privacy.

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