Hirschsprung Disease
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTProbiotics
Probiotics in the form of sachet will be given twice daily for a period of at least 6 months during the trial period.
DIETARY_SUPPLEMENTPlacebo
Multivitamin off-the-counter.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Probiotic Sachets
Intervention model description
Probiotic Sachets
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Hirschsprungs disease confirmed preoperative and postoperative specimen pathology
Exclusion criteria
* Other cases of Enterocolitis and constipation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of Hirschsprung's associated enterocolitis (HAEC) | 6 months | Absence of HAEC symptoms and signs; absence of fever, abdominal distension, loose stools (diarrhea) , bloody stools during the postoperative period for 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of stooling pattern of postoperative Hirschsprung's cases | 6 months | 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. |
Countries
Egypt
Contacts
Primary ContactMahmoud MA Elfiky, M.D.
Backup ContactMostafa A Gad
Outcome results
None listed