Wang 2015.
| Study characteristics | ||
| Methods |
Study design: a prospective, multicentre, randomised controlled trial Location: Department of Pediatric Surgery, Tongji Hospital; The First Hospital of Harbin Medical University; and Anhui Provincial Hospital Setting: hospital |
|
| Participants |
Sample size: 60 participants Sample calculation: no power calculation Number of dropouts/withdrawals: none Age at diagnosis (mean ± SD): 12.63 ± 9.86 months (probiotic); 11.64 ± 8.67 months (placebo) Sex(M/F): 14:16 (probiotic); 17:13 (placebo) Long‐segment aganglionosis (%): 33% (probiotic); 37% (placebo) Diagnostic criteria: confirmed by barium enema, anorectal manometry, and postoperative pathological examination Inclusion criteria: all children suffering from HD who were younger than 18 years old Exclusion criteria: Age >18 years old; children who were complicated with mental and neurological disorders; other congenital gastrointestinal malformations; liver, kidney dysfunction, blood disorders, immune deficiency diseases, and significant ECG abnormalities; children who had been given oral antibiotics, microecological modulator, yogurt, or other gastrointestinal motility drugs which could affect the gut flora; drug allergies or allergic diseases; poor compliance with oral probiotic treatment |
|
| Interventions |
Intervention (N = 28): oral Bifido Dose of probiotic: based on body weight, 1.0 × 10⁸ CFU Type of probiotic:Lactobacillus, Bifidobacterium, Enterococcus Control (N = 32): maize starch Duration of intervention: 4 weeks |
|
| Outcomes |
Primary outcomes: incidence of HAEC; severity of HAEC; CD4⁺, CD8⁺,T lymphocyte flow cytometry Timing of measurements: 3 months |
|
| Notes |
Study start date: January 2008 Study end date: January 2010 Clinical trials record: NCT01934959 Funding source: funded by National Key Specialty Construction Program (2013544) and National Natural Science Foundation of China (PI:Zhi Li;No:81400579) Conflict of interest: not specified |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Quote: "Patients who conform to the inclusion criteria will be randomly and equally assigned into the treatment group and the control group with random number table row randomisation." Comment: adequately done |
| Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information on which to base judgement |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk |
Quote: "Both compounds were indistinguishable in appearance after conventional treatment." Comment: adequately done |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: insufficient information on which to base judgement |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no loss to follow‐up |
| Selective reporting (reporting bias) | Low risk | Comment: The intended outcomes specified in the methods were reported and these were as expected. |
| Other bias | Low risk | Comment: No other apparent biases |
CFU: colony‐forming units; ECG: electrocardiograph; HD: Hirschsprung's disease; HAEC: Hirschsprung‐associated enterocolitis