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Preventing urinary tract infections in infants and children under 2 years with oral Escherichia coli strain Nissle 1917 probiotic: a randomized controlled trial

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on infants and young children under two years who have experienced a feverish Urinary tract infection, an infection of the bladder and the tubes that carry urine, or pyelonephritis, which is an infection of the kidney. It tests whether a daily oral dose of the probiotic E. coli Nissle, a preparation of live beneficial bacteria, can lower the chance of another infection, with the purpose of preventing recurrent infections.

The trial is randomized and double-blind, meaning participants are assigned by chance to receive either the probiotic or a placebo, and neither families nor doctors know which one is given. After completing the standard course of antibiotic treatment, the child takes the study liquid for about 30 days at home. Over the following six months, follow‑up visits and calls record any new infections, hospital stays, extra antibiotic use, and symptoms such as stomach pain or diarrhea, and a laboratory culture test may be used to confirm any new infection.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Begin oral probiotic course
After the last dose of the antibiotic that treated the initial urinary tract infection, start taking the study medication at home.
The medication is an oral suspension called mutaflor (or a matching placebo).
Take 2 doses of the suspension each day for a total of 30‑day course.
Step 2
Continue daily dosing for 30 days
Administer the suspension once in the morning and once in the evening, or as instructed, for the full 30‑day period.
Do not miss any doses; if a dose is forgotten, take it as soon as remembered unless it is close to the next scheduled dose.
Store the suspension according to the packaging instructions.
Step 3
Complete the medication course
After 30 days, stop taking the oral suspension.
No further study medication is required.
Step 4
Monitor for recurrent infection during 6‑month follow‑up
For the next six months, watch for signs of a recurrent urinary tract infection such as fever, pain during urination, or abdominal discomfort.
If any symptoms appear, contact the child's regular health care provider for evaluation.
The study will record any confirmed infections, hospital stays, antibiotic use, abdominal pain days, and diarrhoea days during this follow‑up period.
Step 5
Attend scheduled follow‑up visits
The protocol may include clinic visits at specified times within the six‑month follow‑up to collect information and samples.
Bring the medication bottle and any symptom diaries to these visits.

Who can join the trial?

10 criteria

Child must be younger than 2 years old.
It must be the child’s first urinary tract infection diagnosed while in a pediatric emergency room or hospital ward.
A doctor must think a urinary tract infection is likely because a urine sample shows pyuria (white blood cells in the urine) and the child has symptoms such as fever or local urinary symptoms.
No other more likely cause for the symptoms may be identified.
If a bacterial culture (lab test that grows bacteria from the urine) is available, it must show bacteria that support the infection diagnosis.
A final culture result is not required if the other criteria are met and the child is being discharged with a urinary tract infection diagnosis.
Both boys and girls are eligible.
Use of other probiotic products is allowed, but it must be recorded by the study team.
Parents or legal guardians must give informed consent for the child to join the study.
The child must be recruited at one of the participating hospitals in Finland.

Who cannot join the trial?

7 criteria

Prematurity: children who were born before 35 weeks of pregnancy.
Severe infection: a life‑threatening infection such as E. coli meningitis (meningitis means a serious infection of the brain’s protective covering).
Urinary tract anomaly: any major blockage or defect in the urinary system that would need care from a urologist (a doctor who treats the kidneys, bladder, and related organs).
Immunodeficiency: a condition where the immune system (the body’s defense against germs) is weak.
Bowel anomaly: an abnormal condition of the intestines (the part of the body that digests food).
Current medication: regularly taking antibiotic prophylaxis (antibiotics used every day to try to prevent infections).
Hospital‑acquired infection: an infection caught while in the hospital, especially one related to a catheter (a thin tube placed in the body to drain fluids).

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Helsinki University Central Hospital
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Helsinki, Finland
Kuopio University Hospital
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Kuopio, Finland
Oulu University Hospital
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Oulu, Finland

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Investigated drugs

Mutaflor is an oral suspension that contains a harmless strain of the bacteria Escherichia coli called Nissle 1917. In this trial the product is given to infants and young children after they finish a course of antibiotics for a urinary tract infection. The goal is to see if the probiotic can help prevent another infection by supporting a healthy balance of bacteria in the gut and urinary tract. Children take the suspension by mouth for about a month.

Escherichia Coli Strain Nissle 1917

What is already known about the treatment

Mutaflor 10^8 CFU/ml oraalisuspensio - This product is taken by mouth as a liquid suspension, with a daily dose of two milliliters for 30 days. It contains a live strain of Escherichia coli Nissle 1917, a probiotic that is already marketed in several countries for gut health and is being studied for preventing urinary‑tract infections in children. The bacteria work by settling in the intestine, where they block harmful germs from attaching and help keep the immune system balanced. It is classified as a probiotic (live microbial) product and is listed under antidiarrheal microorganisms (ATC code A07FA).

Investigated diseases

Urinary tract infection - Urinary tract infection is an infection of the urinary system, most often affecting the bladder and urethra. It begins when bacteria enter the urethra and multiply in the bladder, causing discomfort during urination. Symptoms may start as mild irritation and can become more pronounced as the infection spreads. When the infection ascends to the kidneys, it is called pyelonephritis, leading to fever and back pain. In young children, the infection can recur, with each episode following a similar pattern of symptoms.