TABLE 2

Study Characteristics of Included Pediatric Studies on Constipation

StudyParticipantsIntervention vs ControlStudy DurationOutcome MeasureResultsLoss to Follow-up Monitoring, n/N (%)
Fiber
    Loening-Baucke et al11 (LQ)31 children, 4.5–11.7 y of age, with constipation for ≥6 mo, recruited from tertiary pediatric gastroenterology clinic in United StatesGlucomannan (fiber), 100 mg/kg per d up to 5 g/d, vs placebo (maltodextrins)4 wkDefecation frequency of <3 times per wk
Abdominal pain
“Improved” (physician rating)
“Improved” (parent rating)
Intervention: 19%; control: 52% (P < .05)
Intervention: 10%; control: 42% (P < .05)
Intervention: 45%; control: 13% (P < .05)
Intervention: 68%; control: 13% (P < .05)
15/46 (32)
    Castillejo et al13 (HQ)56 children, 3–10 y of age, with chronic idiopathic constipation according to Rome II criteria, recruited from tertiary pediatric gastroenterology clinic in SpainCocoa husk supplement (fiber), 10.4 g/d (3–6 y) or 20.8 g/d (7–10 y), vs placebo4 wkChange in colonic transit time
Mean defecation frequency
No. of patients with subjective improvement in stool consistency
No. of patients with subjective improvement in pain
Intervention: 61.4 h to 43.6 h; control: 71.5 h to 61.5 h (no significance)
Intervention: 6.2 times per wk; control: 5.1 times per wk (P = .78)
Intervention: 14; control: 6 (P < .039)
Intervention: 16; control: 11 (P = .109)
Intervention: 4/28 (14); control: 4/28 (14)
    Kokke et al14 (LQ)97 children, 1–13 y of age, with ≥2 of 4 criteria for constipation (<3 bowel movements per wk, ≥2 fecal incontinence episodes per wk, periodic passage of stool at least once every 7–30 d, or palpable abdominal or rectal mass), recruited from general pediatric practice clinic in NetherlandsFiber (10 g in 125-mL yogurt drink) vs lactulose (10 g in 125-mL yogurt drink)8 wk≥1 fecal incontinence episode per wk
Mean abdominal pain scores
Mean flatulence scores
Necessity of step-up medication
Taste scores
Intervention: 4%; control: 3% (P = .084)
Week 3: intervention: 1.58; control: 1.43 (P = .33); week 8: intervention: 1.49; control: 1.39 (P = .50)
Week 3: intervention: 1.9; control: 2.0 (P = .70); week 8: intervention: 2.0; control: 1.9 (P = .94)
P = .99; absolute numbers not reported
P = .657; absolute numbers not reported
Intervention: 1/65 (1.5), 22/65 (33.8) stopped; control: 2/70 (2.9), 11/7 (15.7) stopped
Fluid
    Young et al15 (LQ)108 children, 2–12 y of age, with scores of ≥8 on constipation assessment scale, recruited from pediatric gastroenterology department in United States50% water intake increase, hyperosmolar (>600 mOsm/L) supplemental fluid treatment, or normal fluid intake3 wkStool frequency
Difficulty in passing stools (0 = no problem, 1 = some problem, 2 = severe problem)
Stool consistency score
50% water intake increase: 3.70 times per wk; hyperosmolar fluid: 3.44 times per wk; normal fluid intake: 3.40 times per wk (significance not assessed)
50% water intake increase: 0.87; hyperosmolar fluid: 0.62; normal fluid intake: 1.06 (significance not assessed)
50% water intake increase: 6.30; hyperosmolar fluid: 5.79; normal fluid intake: not reported (significance not assessed)
?
Prebiotics and probiotics
    Bongers et al16 (HQ)38 children, 3–20 wk of age, receiving ≥2 bottles of milk-based formula per d with ≥1 of following symptoms: 3 bowel movements per wk, painful defecation (crying), or abdominal or rectal palpable mass, recruited from tertiary pediatric gastroenterology department in NetherlandsNew formula with high concentration of sn-2 palmitic acid, mixture of prebiotic oligosaccharides, and partially hydrolyzed whey protein (Nutrilon Omneo) vs standard formula (Nutrilon 1)3 wk
Improvement of hard stools to soft stools
Mean defecation frequency
Intervention: 90%; control: 50% (P = .14)
Intervention: 5.6 times per wk; control: 4.9 times per wk (P = .36)3 wk: 3/38 (7.9); 6 wk: 14/38 (37)
    Banaszkiewicz et al17 (HQ)84 children, 2–16 y of age. with <3 bowel movements per wk for ≥12 wk, recruited from pediatric gastroenterology department in PolandLactobacillus GG, 109 colony-forming units twice per d, + 70% lactulose, 1 mL/kg per d, vs placebo + 70% lactulose, 1 mL/kg per d12 wk
Mean defecation frequency at 12 wk
Mean frequency of fecal soiling at 12 wk
Mean frequency of straining at 12 wk
Treatment success (>3 bowel movements per wk without fecal soiling)
Intervention: 6.1 times per wk; control: 6.8 times per wk (P = .5)
Intervention: 0.8 episodes per wk; control: 0.3 episodes per wk (P = .9)
Intervention: 1.3 times per wk; control: 1.6 times per wk (P = .6)
12 wk: intervention: 72%; control: 68% (P = .9); 24 wk: intervention: 64%; control: 65% (P = 1.0)Intervention: 5/43 (11.6); control: 3/41 (7.3)
    Bu et al18 (HQ)45 children, 0–10 y of age, with <3 bowel movements per wk for >2 mo and 1 of the following: anal fissures with bleeding, fecal soiling, or passage of large hard stools, recruited from general pediatric practice in TaiwanLactobacillus casei rhamnosus (N = 18), 8 ×108 colony-forming units per d; magnesium oxide (control 1), 50 mg/kg per d (N = 18); or placebo (control 2) (N = 9)4 wk
Mean frequency of abdominal pain
Treatment success (defined as ≥3 bowel movements per wk without fecal soiling by fourth wk)
Mean frequency of fecal soiling
Proportion of hard stools
Frequency of use of lactulose
Mean defecation frequency
Intervention: 1.9 times per d; control 1: 4.8 times per d (P = .04)
Intervention: 78%; control 1: 72% (P = .71)
Intervention: 2.1 episodes per wk; control 1: 2.7 episodes per wk (significance not assessed)
Intervention: 22.4%; control 1: 23.5% (P = .89)
Intervention: 4.4 times per wk; control 1: 5.0 times per wk (significance not assessed)
Intervention: 0.6 times per d; control 1: 0.5 times per d (P = .77)4/45 (8.8)
Behavioral therapy
    Taitz et al19 (LQ)47 children with fecal incontinence, with or without constipation, recruited from general pediatric department in United KingdomPsychotherapy vs behavior modification techniques12 moCure, improvement, or no response (see text)Cure: n = 22; improvement: n = 8; no response: n = 1617/47 (36)
    van Dijk et al12 (HQ)134 children with functional constipation (≥2 of 4 criteria: defecation frequency of <3 times per wk, fecal incontinence ≥2 times per wk, passage of large amounts of stool at least once every 7–30 d, or palpable abdominal or rectal fecal mass) recruited from tertiary pediatric gastroenterology department in NetherlandsBehavioral therapy vs conventional treatment6 mo
Mean fecal incontinence frequency
Success rate (≥3 bowel movements per wk and fecal incontinence frequency of ≤1 time per 2 wk, irrespective of laxative use)
Mean defecation frequency
22 wk: 5 vs 2.1 episodes per wk; 6 mo: 8.6 vs 6.4 episodes per wk (P = .135)
22 wk: 51.5% vs 62.3% (P = .249); 6 mo: 42.3% vs 57.3% (P = .095)
22 wk: 5.4 vs 7.2 times per wk; 6 mo: 5.3 vs 6.6 times per wk (P = .021)20/134 (14.9)
  • HQ indicates high quality; LQ, low quality.