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. 2021 Jan 20;8:595531. doi: 10.3389/fped.2020.595531

Table 2.

Characteristics of studies assessing the effects of probiotics on children with constipation.

References Year Country Age (yr) n (intervention/control) Intervention Protocol (intervention, control, duration) Clinical Response Criteria Treatment Effect (intervention vs. control)
Banaszkiewicz et al. (71) 2005 Poland 2–16 84 (43/41) Lactobacillus rhamnosus GG, + lactulose
Placebo + lactulose
12 wk, 24 wk
≥3 spontaneous BM per week, decreased episodes of fecal incontinence ≥3 spontaneous BM frequency NS, 12 wk
≥3 spontaneous BM frequency NS, 24 wk
Bu et al. (64) 2007 Taiwan <10 45 (18/18/9) Lactobacillus casei rhamnosus Lcr35
Magnesium oxide
Placebo
4 wk
≥3 spontaneous BM per week, decreased episodes of fecal incontinence in the fourth week Achieved ≥3 spontaneous BM frequency (0.57 ± 0.17 vs. 0.55 ± 0.13 vs. 0.37 ± 0.10; P = 0.03)
Hannah et al. (72) 2008 Indonesia 0.5–14 43 (23/20) Synbiotic mixturea
Placebo + saccharin
1 wk
Increased BM frequency, improvement in BM consistency, decrease in pain with defecation, no treatment side effects Increased BM frequency, improved BM consistency, improvement in pain with defecation, side effects NS
Coccorullo et al. (73) 2010 Italy >0.5 44 (22/22) Lactobacillus reuteri DSM 17938
Placebo
8 wk
≥3 spontaneous BM per week Achieved ≥3 spontaneous BM frequency (P = 0.008)
Khodadad et al. (74) 2010 Iran 4–12 102 (37/33/32) Synbiotic mixture (Protexin)b + liquid paraffin
Synbiotic mixture (Protextin)b + placebo
Liquid paraffin + placebo
4 wk
≥3 spontaneous BM per week, ≤ 2 fecal soiling per month, decrease in abdominal pain Achieved ≥3 spontaneous BM all groups (P <0.001, highest in symbiotic + liquid paraffin group), fecal soiling and abdominal pain NS
Guerra et al. (75) 2011 Brazil 5–15 60 (30/30) Goat yogurt with probiotic culturesc
Placebo (goat yogurt without probiotic cultures)
10 wk (crossover at 5 wk)
Increased BM frequency, improvement in BM consistency, decrease in abdominal, decrease in pain with defecation Increased BM frequency (P = 0.012), BM consistency NS, improvement in abdominal pain (P = 0.015), improvement in pain with defecation (P = 0.046)
Tabbers et al. (76) 2011 Netherlands and Poland 3–16 159 (79/80) Activia with probiotic culturesd
Placebo (yogurt without probiotic cultures + low lactose content)
3 wk
≥3 spontaneous BM per week, <1 fecal incontinence in the last 2 weeks ≥3 spontaneous BM NS
Sadeghzadeh et al. (77) 2014 Iran 4–12 56 (28/28) Probiotic mixture (Protexin)e + lactulose
Placebo + lactulose
4 wk
Increased BM frequency, improvement in BM consistency Increased BM frequency all groups (2.08 ± 0.65 and 1.54 ± 0.98 P = 0.042), improved BM consistency (0.88 ± 0.45 vs. 0.63 ± 0.50, P = 0.049)
Hashemi et al.* (78) 2015 Iran 2–16 120 (40/40/40) Synbiotic mixture (Kidilact)b + PEG
Placebo + synbiotic mixture (Kidilact)b
Placebo + PEG
6 wk
Not available Significant improvement in constipation symptoms with synbiotic mixture + PEG.
Abediny et al.* (79) 2016 Iran 4–12 90 (45/45) Synbiotic mixture (Kidilact)b + PEG
PEG
4 wk
Increased BM frequency, decrease in abdominal pain, decrease in painful defecation BM frequency and painful defecation NS; improved abdominal pain (P < 0.05)
Wojtyniak et al. (65) 2017 Poland <5 94 (48/46) Lactobacillus casei rhamnosus Lcr35
Placebo, 99% milk powder + 1% magnesium stearate
4 wk
≥3 spontaneous BM per week, decreased episodes of fecal incontinence in the last week of intervention ≥3 spontaneous BM NS
Mahdavi et al. (80) 2017 Iran 2–10 94 (48/46) Synbiotic mixture (Kidilact)b + PEG
PEG
4 wk
Increased BM frequency, improvement in stool consistency, decrease in pain with defecation, decrease in number of withholding episodes per week, decreased episodes of fecal incontinence per week, no treatment adverse events BM frequency, stool consistency, pain, and withholding NS; improvement in fecal incontinence (0.289 vs. 0.02, P = 0.005)
Russo et al. (81) 2017 Italy 4–12 55 (27/28) Probiotic mixture (Tribif)f + PEG
PEG
8 wk
≥3 spontaneous BM per week, increased BM frequency, improvement in BM consistency Bristol ≥ grade 3, decrease in abdominal pain, decreased episodes of fecal incontinence, decreased rectal bleeding with defecation ≥3 spontaneous BM, BM frequency, BM consistency, abdominal pain, fecal incontinence and rectal bleeding NS
Bastürk et al. (82) 2017 Turkey 4–18 155 (77/78) Synbiotic mixtureg + prebioticsh
Placebo
4 wk
Increased BM frequency, improvement in BM consistency (Bristol type), decrease in abdominal pain, decrease in pain with defecation Increased BM frequency (p ≤ 0.001), improvement in BM consistency (p ≤ 0.001), improvement in abdominal pain (p ≤ 0.001), improvement in pain with defecation (p ≤ 0.001)
Jose et al. (83) 201 India <18 60 (30/30) Probiotic mixture (Protexin)b + lactulose
Placebo + lactulose
4 wk
Increased BM frequency, improvement in BM consistency, decrease in abdominal pain, decreased episodes of fecal incontinence, no treatment side effects Increased BM frequency, improvement in BM consistency; abdominal pain and fecal incontinence NS
Wegner et al. (84) 2018 Poland 3–7 129 (65/64) Lactobacillus reuteri DSM 17938 + PEG
Placebo + PEG
8 wk
≥3 spontaneous BM per week, increased BM frequency, improvement in BM consistency, decrease in pain with defecation, decreased episodes of fecal incontinence ≥3 spontaneous BM, BM frequency, BM consistency, painful defecation and fecal incontinence NS
Jadrešin et al. (95) 2018 Croatia 2–18 33 (18/15) L. reuteri DSM 17938 + lactulose
Placebo + lactulose
12 wk
Increased BM frequency, improvement in BM consistency, improvement in symptoms at the end of the study, decreased dose of the lactulose needed, and decreased episodes of fecal incontinence BM frequency, BM consistency, presence of symptoms, lactulose and fecal incontinence NS

Data extracted from systematic review and meta-analysis by Harris et al. (70) BM, bowel movement; NS, not significant; PEG, polyethylene glycol; RR, relative risk.

a

Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus bulgaricus, Bifidobacterium infantis, Bifidobacterium breve, Streptococcus thermophiles.

b

Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium infantis, fructooligosaccharide.

c

Bifidobacterium longum, Lactobacillus delbrueckii subsp. bulgaricus, Streptococcus thermophiles.

d

Bifidobacterium lactis DN-173010, Lactobacillus delbrueckii subsp. bulgaricus, Streptococcus thermophiles.

e

Lactobacillus casei PXN 37, Lactobacillus rhamnosus PXN 54, Streptococcus thermophiles PXN 66, Bifidobacterium breve PXN 25, Lactobacillus acidophilus PXN 35, Bifidobacterium infantis (child specific) PXN 27, and Lactobacillus bulgaricus PXN 39.

f

Bifidobacterium breve M-16 V, Bifidobacterium infantis M-63, Bifidobacterium longum BB536.

g

Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium lactis.

h

Fiber, polydextrose, fructo-oligosaccharides, galacto-oligosaccharides.

*

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