An Early Phase 1 interventional study of Bifico in Probiotics and Hirschsprung's Disease Associated Enterocolitis, sponsored by Tongji Hospital. Completed. Open to participants aged 1 Month to 13 Years. Per ClinicalTrials.gov, last updated 2013-09-04.
Sponsored by Tongji Hospital · Early Phase 1, Interventional, and Treatment
Enterocolitis(EC) is the most common and serious postoperative complication of Hirschsprung's disease(HD) with high morbidity and mortality. Probiotics are live microbes that, when administered in adequate amounts, confer health benefit to the host.Based on this previous knowledge on the beneficial effects of probiotics during pro-inflammatory conditions of the gastrointestinal tract, investigators hypothesized that oral probiotics could decrease the incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).Investigators conducted a prospective, multicenter, randomized and controlled trial to assess whether oral probiotics could decrease the incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).
216 studies on the registry are indexed under Enterocolitis; 26 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 123 interventional studies indexed under Enterocolitis.
Browse Enterocolitis studies →Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The inclusion criteria consists of all patients suffering from HD at an age of less than 13 years old, and HD is confirmed by postoperative pathological examination, barium enema and anorectal manometry.
Exclusion Criteria:
Drug: Bifico
Probiotics Prevent Hirschsprung's Disease Associated Entercolitis
Time frame: two years
No study locations are listed for this record.
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Tongji Hospital