Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Hirschsprung Disease

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT02343562

CAIUNIPEDSURG-CR1

PACTR201408000867421 (Other Identifier)

Details and patient eligibility

About

Hirschsprungs Associated Enterocolitis (HAEC) with incidence up to 30% postoperatively. The objective of the trial is to prevent postoperative HAEC by using Probiotics.

Full description

Randomised Controlled Study with two arms. All cases following up for post operative Hirschsprungs surgery are included in this study. First arm will receive a probiotics in the form of sachet for 6 months. Second arm will receive a multivitamin as placebo. Comparative analysis between the two groups for baseline and followup prevalence of Hirschsprungs associated enterocolitis.

Enrollment: 40 estimated patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Hirschsprungs disease confirmed preoperative and postoperative specimen pathology

Exclusion criteria

• Other cases of Enterocolitis and constipation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Probiotics Group

Active Comparator group

Description:

Will receive Sachet-form probiotics

Treatment:

Dietary Supplement: Probiotics

Placebo Group

Placebo Comparator group

Description:

Will receive off-the-shelf oral multivitamin

Treatment:

Dietary Supplement: Placebo