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| ID | Type | Description | Link |
|---|---|---|---|
| PACTR201408000867421 | Other Identifier | PACTR |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics Group | Active Comparator | Will receive Sachet-form probiotics |
|
| Placebo Group | Placebo Comparator | Will receive off-the-shelf oral multivitamin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | Probiotics in the form of sachet will be given twice daily for a period of at least 6 months during the trial period. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahmoud MA Elfiky, M.D. | Contact | +201001557755 | mfiky@kasralainy.edu.eg | |
| Mostafa A Gad | Contact | +201002265009 | mostafagad@kasralainy.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Mahmoud MA Elfiky, M.D. | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Pediatric Hospital | Recruiting | Cairo | 11432 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23331802 | Background | El-Sawaf M, Siddiqui S, Mahmoud M, Drongowski R, Teitelbaum DH. Probiotic prophylaxis after pullthrough for Hirschsprung disease to reduce incidence of enterocolitis: a prospective, randomized, double-blind, placebo-controlled, multicenter trial. J Pediatr Surg. 2013 Jan;48(1):111-7. doi: 10.1016/j.jpedsurg.2012.10.028. | |
| Background | Demehri, Farokh R., et al. |
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| ID | Term |
|---|---|
| D006627 | Hirschsprung Disease |
| ID | Term |
|---|---|
| D004065 | Digestive System Abnormalities |
| D004066 | Digestive System Diseases |
| D008531 | Megacolon |
| D003108 | Colonic Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Probiotic Sachets
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Probiotic Sachets
|
| Placebo | Dietary Supplement | Multivitamin off-the-counter. |
|
|
| 6 months |
| D007410 |
| Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019602 |
| Food and Beverages |