A Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis

Tongji Hospital

Status and phase

Completed

Early Phase 1

Conditions

Hirschsprung's Disease Associated Enterocolitis

Probiotics

Treatments

Drug: Bifico

Study type

Interventional

Funder types

Other

Identifiers

NCT01934959

Tongji

Details and patient eligibility

About

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).

Enrollment

60 patients

Sex

All

Ages

1 month to 13 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Age> 13 years old
Patients are complicated with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or can not thrive.
Patients are complicated with congenital gastrointestinal malformations (such as anal stenosis, intestinal atresia stenosis), metabolic and endocrine diseases caused by organic constipation and functional constipation in children.
Children are complicated with liver, kidney dysfunction, blood disorders, immune deficiency diseases and significant ECG abnormalities.
Children have taken oral antibiotics, microecological modulator, yogurt, other gastrointestinal motility drugs which can affect the gut flora.
Drug allergies, or allergic diseases..
Poor compliance with oral probiotics treatment.