Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis

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

Detailed Description
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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.

Official Title
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Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis

Conditions
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Hirschsprung Disease

Intervention / Treatment
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* Dietary Supplement: Probiotics
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hirschsprungs disease confirmed preoperative and postoperative specimen pathology Exclusion Criteria: Other cases of Enterocolitis and constipation

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Probiotic Sachets
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotics Group<br>Will receive Sachet-form probiotics | Dietary Supplement: Probiotics<br>* Probiotics in the form of sachet will be given twice daily for a period of at least 6 months during the trial period.<br>* Other names: Lacteol Forte;|
| Placebo Comparator: Placebo Group<br>Will receive off-the-shelf oral multivitamin | Dietary Supplement: Placebo<br>* Multivitamin off-the-counter.<br>* Other names: Multisanostol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of Hirschsprung's associated enterocolitis (HAEC) | Absence of HAEC symptoms and signs; absence of fever, abdominal distension, loose stools (diarrhea) , bloody stools during the postoperative period for 6 months. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of stooling pattern of postoperative Hirschsprung's cases | Bowel habits and motion data are recorded at base line (start of the study) and measured throughout the study. Number of motions per day, stool consistency and periodic culture and sensitivity analysis of the stools. Improvement is measured by optimising stool output to 2-3 times daily, stool consistency according to age should be semi-solid to solids. Stool analysis improvement criteria include better consistency, absence of pus cells or red blood cells and no growth on culture for pathogenic bacteria. | 6 months |