Efficacy of Probiotic

Prophylaxis in Children
with Normal Urinary Tracts
S. Sadeghi-bojd, R. Naghschizadian, M. Mazehari, F.
Ghane Sharbaf, F. Assadi

Journal of the Pediatric Infectious Diseases Society

2020 Jul 13;9(3):305-310

Pembimbing
dr. Gusti Ayu Putu Nilawati, Sp.A(K), MARS
dr. Bagus Ngurah Mahakrishna, M. Biomed., Sp.A
PICO
P (population) : anak dengan riwayat infeksi saluran kemih
I (intervention) : probiotik
C (comparator) : placebo
O (outcome) : rekurensi infeksi saluran kemih
Pertanyaan Klinis
Pada anak dengan riwayat infeksi saluran kemih, apakah pemberian probiotik lebih baik
daripada placebo untuk mencegah rekurensi infeksi saluran kemih ?
HASIL PENELUSURAN JURNAL
“Efficacy of Probiotic Prophylaxis in Children with Normal Urinary Tracts” 
S. Sadeghi-bojd, R. Naghschizadian, M. Mazehari, F. Ghane Sharbaf, F. Assadi
Journal of the Pediatric Infectious Diseases Society 2020 Jul 13;9(3):305-310

2
Latar Belakang
● Infeksi saluran kemih merupakan infeksi yang sering didapatkan pada anak dan
dapat menyebabkan morbiditas yang signifikan dan kematian.
● Penggunaan rutin antibiotik profilaksis saat telah menjadi perdebatan karena
efek samping dan resistensi antibiotika.
● Rekomendasi AAP (2011): anak usia 2-24 bulan tidak diberikan profilaksis
antimikroba setelah episode ISK febris pertama bila hasil USG ginjal dan
kandung kemih normal.
● Rekurensi ISK yang tinggi dan potensi resistensi antibiotika mendorong
penelitian mengenai perlakuan non-antibiotika (jus cranberry, estrogen topical,
dan probiotik).

3
Latar Belakang
● Probiotik dalam jumlah tertentu dapat menjadi barrier terhadap bakteri
urogenitalia secara ascending pada tractus urinarius dan menyebabkan
infeksi.
● Efek probiotik diperkirakan melalui mediasi perbaikan flora vagina dan
intestinal (menghambat adherence, pertumbuhan, dan kolonisasi bakteri
pathogen dan meningkatkan daya tahan host)
● Penelitian mengenai manfaat probiotik untuk mencegah ISK masih
terbatas.

4
1 TUJUAN
 “
Peranan probiotik dalam mencegah
infeksi saluran kemih pada anak sehat

”6
2 METODE
 Metode
Randomized controlled double-blind
trial
Multicenter (4 klinik RS di Iran)
Januari 2017 – Nov 2018 (1 tahun
10 bulan)
Anak usia 4 bulan-5 tahun yang
sembuh dari episode pertama
ISK febril simpleks (kultur urin
steril)
Kriteria
Inklusi:
- Sembuh dari ISK simpleks dengan febris
(kultur urin steril)
- USG ginjal dan kandung kemih normal
Eksklusi:
• Imunodefisiensi,
• Disfungsi berkemih
• Fungsi ginjal menurun
• Vesicoureteral reflux (VUR)
• Hipertensi
• Insufisiensi hepar
• Dalam pengobatan antibiotik
• Penggunaan probiotik 3 bulan terakhir
8
 ● Lactobacillus acidophilus
Intervensi (15 × 109 CFU),
● Lactobacillus rhamnosus
Probiotik
(1.0 × 109 CFU),
500 mg kapsul probiotik ● Bifidobacterium bifidum (4 ×
(complete probiotic platinum 109 CFU),
berisi 11 strain Lactobacillus ● Bifidobacterium lactis
dan Bifidobacterium spp) (15x109 CFU)
Dilarutkan dalam 10 ml D5% (500 mg/10 ml) dan diberikan 0.5 ml (25
mg)/kg sebanyak 2 kali per hari (max. dosis harian 29 ml (1.0 g)
dengan atau tanpa makanan selama studi.

9
Intervensi
Probiotik
Dosis 106 – 109 CFU Lactobacillus dan Bifidobacterium spp adalah
dosis minimum yang efektif untuk terapeutik pada dewasa

Partisipan dan peneliti tidak mengetahui isi botol (probiotik/air)

Petugas farmasi menyiapkan sediaan dan distribusi probiotik selama

periode penelitian

10
Placebo
Volume sama 0.5 ml/kg) konsumsi air 2 kali sehari setiap hari selama studi

11
Prosedur
Probiotik / placebo Orangtua Partisipan
menyimpan produk di
kulkas
Setiap 2-4 minggu

Setiap minggu dihubungi oleh tim peneliti

(kepatuhan dan gejala ISK)

12
Prosedur
● Subjek dieksklusi bila kepatuhan <80% selama kunjungan setiap minggu
oleh tim peneliti.

● ISK dicurigai bila terdapat gejala demam tanpa sumber demam yang jelas
dan dikonfirmasi dari kultur urin ditemukan pathogen min. 50.000 CFU/mL
melalui transurethral atau aspirasi suprapubic

● Piuria : leukosit ≥10 per 𝞵L dari sampel urin yang telah disentrifugasi

● Anak dengan ISK simptomatik diberikan antibiotik sesuai guideline

13
Prosedur
● Luaran primer: UTI-free survival 18 bulan setelah terapi dimulai

● Luaran sekunder : median waktu rekurensi ISK pertama

14
Statistik
● Jumlah partisipan yang dibutuhkan
pada setiap kelompok : 70 sampel
● Power 95%, 𝛂 1%
● Antisipasi lost to follow up, data tidak
lengkap, compliance buruk : 10%
● Sampel diperkirakan : 83 per
kelompok

15
Statistik
● Data kontinyu : mean dan SD
● Data kategorik : proporsi
● Uji statistik : Fisher exact test (kategorik), dan Student-T test (kontinyu)
● X2 digunakan untuk membandingkan kelompok placebo dan probiotik
● Kaplan meier : prediksi probabilitas ISK selama studi
● Pearson regression model : perkiraan angka rekurensi ISK saat follow up

16
Statistik
● P value <0.5 : signifikan
● SPSS 13.0

17
Alur Penelitian

18
Hasil Tabel 1. Karakteristik Pasien (Intention-to-treat population)

Karakteristik dasar subjek kedua kelompok tidak berbeda signifikan

19
 Hasil
Composite cure :
96.7% (3 dari 91 pasien) pada
probiotik

83.3% (15 dari 90) pada

placebo

Perbedaan -13.3% (95% CI,

interval -8.9 – 4.1)

Gambar 2. Kaplan-Meier Model perkiraan probabilitas rekurensi ISK

selama profilaksis pada kedua kelompok subjek

20
Hasil
• Median waktu insiden ISK rekuren pertama yaitu 3.5 bulan (1-4 bulan)
dan 6.5 bulan (2-14 bulan) pada probiotik dan placebo.
• Perempuan rekurensi ISK > laki-laki pada kedua kelompok [(11.5% vs
0%) pada probiotik, (27.4% vs 5%) pada placebo ; P= 0.02]
• Anak usia <12 bulan : insiden rekurensi ISK > anak usia >12 bulan
(2.2% pada probiotik vs 11.1% pada placebo) P= 0.04)

21
Hasil
Tabel 2. Rerata Keseluruhan Insiden ISK setelah 18 Bulan Terapi

22
Hasil
• Mikroorganisme utama penyebab ISK Escheria coli (88%), diikuti oleh
Klebsiella pneumoniae (12%)
• Tidak ada kejadian efek samping spesifik akibat probiotik selama studi.

23
3 DISKUSI
 Our process is easy
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consectetur adipiscing elit, sed do
eiusmod tempor. Donec facilisis lacus
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consectetur adipiscing elit, sed do
eiusmod tempor. Donec facilisis lacus
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01 02
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Lorem ipsum dolor sit amet,
consectetur adipiscing elit, sed do
eiusmod tempor. Donec facilisis lacus
eget mauris.

25
Let’s review some concepts
Yellow
Is the color of gold, butter and ripe
lemons. In the spectrum of visible
light, yellow is found between green
and orange.
Yellow
Is the color of gold, butter and ripe
lemons. In the spectrum of visible
light, yellow is found between green
and orange.
Blue
Is the colour of the clear sky and the
deep sea. It is located between violet
and green on the optical spectrum.
Blue
Is the colour of the clear sky and the
deep sea. It is located between violet
and green on the optical spectrum.
Red
Is the color of blood, and because of
this it has historically been
associated with sacrifice, danger and
courage.
Red
Is the color of blood, and because of
this it has historically been
associated with sacrifice, danger and
courage.
26
4000

3000

2000

1000

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Thanks!
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31
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2 Extra Resources
For Business Plans, Marketing Plans, Project
Proposals, Lessons, etc
 Timeline
Blue is the colour of the Yellow is the color of Blue is the colour of the
clear sky and the deep Red is the colour of Black is the color of gold, butter and ripe White is the color of milk clear sky and the deep
sea danger and courage ebony and of outer space lemons and fresh snow sea

JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC

Yellow is the color of White is the color of milk Blue is the colour of the Red is the colour of Black is the color of Yellow is the color
gold, butter and ripe and fresh snow clear sky and the deep danger and courage ebony and of outer space of gold, butter and
lemons sea ripe lemons

35
Roadmap
Blue is the colour of the Red is the colour of danger Black is the color of ebony
clear sky and the deep sea and courage and of outer space

1 3 5

2 4 6

Yellow is the color of gold, White is the color of milk Blue is the colour of the
butter and ripe lemons and fresh snow clear sky and the deep sea

36
Gantt chart
Week 1 Week 2

1 2 3 4 5 6 7 8 9 10 11 12 13 14

Task 1

Task 2 ◆

Task 3

Task 4 ◆

Task 5 ◆

Task 6

Task 7

Task 8

37
SWOT Analysis
STRENGTHS WEAKNESSES
Blue is the colour of the Yellow is the color of gold,
clear sky and the deep sea butter and ripe lemons

Black is the color of ebony White is the color of milk

and of outer space and fresh snow
OPPORTUNITIES THREATS

38
Business Model Canvas

Key Partners Key Activities Value Propositions Customer Customer Segments

Insert your content Insert your content Insert your content Relationships Insert your content
Insert your content

Key Resources Channels

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Cost Structure Revenue Streams

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Funnel

AWARENESS Insert your content

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INTENT Insert your content

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Team Presentation

Imani Jackson Marcos Galán Ixchel Valdía Nils Årud

JOB TITLE JOB TITLE JOB TITLE JOB TITLE
Blue is the colour of the clear Blue is the colour of the clear Blue is the colour of the clear Blue is the colour of the clear
sky and the deep sea sky and the deep sea sky and the deep sea sky and the deep sea

41
 Competitor Matrix HIGH VALUE 2

Competitor
Compe
titor
Our company

Competitor

HIGH VALUE 1
LOW VALUE 1

Competitor

Competitor Competitor

LOW VALUE 2 42
Weekly Planner
SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY

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