Probiotics for newborn babies with surgical conditions of the gut

Not Applicable

Completed

• Conditions: Major congenital gastrointestinal anomalies; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Surgery - Other surgery; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12617001401347
• Lead Sponsor: Princess Margaret Hospital for Children

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-04
• Study Completion: 2020-04-27
• Last Update Posted: 19 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

(1) Neonates (>=35 weeks gestation) with the following major congenital gastrointestinal anomalies: Intestinal Atresia (duodenal, jejunal, ileal or colonic), Intestinal Malrotation, Tracheo-Oesophageal fistula, Oesphageal atresia, Gastroschisis, Exompholos, Congenital Diaphragmatic Hernia, Meconium ileus or peritonitis requiring laparotomy, Hirschsprung Disease, Anal atresia, Impeforate anus, Short Bowel Syndrome, and any surgical condition needing the creation of small or large intestinal stoma (eg severe meconium ileus, micro-colon).

Exclusion Criteria

(1) Non gastrointestinal surgical conditions. (2) Neonates born at <35 weeks' gestation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcomes: Gut microbiota (using 16 s r RNA Pyrosequencing studies for phylogenic profiling) on the stool samples [On the stool samples collected a. as soon as possible after admission, but prior to the commencement of supplementation b) 7-9 days after commencement of supplementation, c) 14-16 days after commencement of supplementation, and d) prior to discharge from the neonatal unit (in those who stay more than 4 weeks after commencing supplementation). This amendment to the protocol was approved by the institutional HREC on 25 January 2018. ]

Secondary Outcome Measures

Name	Time	Method
Stool Short Chain Fatty Acids (SCFA) assay using gas chromatography[On the stool samples collected a. as soon as possible after admission, but prior to the commencement of supplementation b) 7-9 days after commencement of supplementation, c) 14-16 days after commencement of supplementation, and d) prior to discharge from the neonatal unit (in those who stay more than 4 weeks after commencing supplementation). This amendment to the protocol was approved by the institutional HREC on 25 January 2018.];Blood culture positive sepsis[During initial hospitalisation];Duration of antibiotic therapy[During initial hospitalisation];Duration of hospital stay (days)[During initial hospitalisation];Time (days) to achieve full enteral feeds of 120 ml/kg/day. [During initial hospitalisation]