Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis
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|ClinicalTrials.gov Identifier: NCT02343562|
Recruitment Status : Unknown
Verified January 2018 by Mahmoud Elfiky, MD, Cairo University.
Recruitment status was: Recruiting
First Posted : January 22, 2015
Last Update Posted : January 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hirschsprung Disease||Dietary Supplement: Probiotics Dietary Supplement: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Probiotic Sachets|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||Probiotic Sachets|
|Official Title:||Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Probiotics Group
Will receive Sachet-form probiotics
Dietary Supplement: Probiotics
Probiotics in the form of sachet will be given twice daily for a period of at least 6 months during the trial period.
Other Name: Lacteol Forte
Placebo Comparator: Placebo Group
Will receive off-the-shelf oral multivitamin
Dietary Supplement: Placebo
Other Name: Multisanostol
- Prevention of Hirschsprung's associated enterocolitis (HAEC) [ Time Frame: 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.
- Improvement of stooling pattern of postoperative Hirschsprung's cases [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343562
|Contact: Mahmoud MA Elfiky, M.D.||+email@example.com|
|Contact: Mostafa A Gadfirstname.lastname@example.org|
|Principal Investigator:||Mahmoud MA Elfiky, M.D.||Cairo University|