None listed
Conditions
Brief summary
Newborn babies with serious surgical conditions of the gut are admitted to intensive care units, undergo surgery, and receive intravenous drips and strong antibiotics. The administration of breast milk is often delayed in these infants. All these factors interfere with the normal development of healthy bacteria in their intestines and enhance the proliferation of harmful bacteria. Such an imbalance between healthy and unhealthy bacteria in the gut can be harmful to the health and well-being of these babies. In this study, we plan to give healthy bacteria called probiotics orally for 30 surgical newborn babies and placebo for 30 surgical newborn babies to see if probiotics help improve their intestinal bacteria and overall health. The results of this study will help us design a much larger study in the future. If that larger study confirms the benefits, probiotics will then be used routinely for all newborn babies with surgical conditions of the gut.
Interventions
Intervention: Mixture of 3 strains (B. breve M-16V, B. longum subsp. infantis M-63 and B. longum subsp. longum BB536 (1×109 Colony Forming Units of each strain per 1 g sachet: Probiotic group).
Supplementation protocol: As soon as possible after admission, enrolled neonates will be supplemented with freshly reconstituted contents of the allocated sachets every day, and continued until discharge.
Reconstitution of the dry powder in the sachets will be done using sterile water for injection or b
Intervention: Mixture of 3 strains (B. breve M-16V, B. longum subsp. infantis M-63 and B. longum subsp. longum BB536 (1×109 Colony Forming Units of each strain per 1 g sachet: Probiotic group). Supplementation protocol: As soon as possible after admission, enrolled neonates will be supplemented with freshly reconstituted contents of the allocated sachets every day, and continued until discharge. Reconstitution of the dry powder in the sachets will be done using sterile water for injection or breast milk. Care will be taken during reconstitution to reduce the risk of cross contamination by adhering to strict hand hygiene. The dose will be 3×109 CFU/day ( i.e. 3 billion organisms per day) in 1.5 ml of the reconstituted solution, given as a single daily dose via the orogastric/nasogastric feeding tube or orally. Supplementation will be continued until discharge from the neonatal unit. The principal investigator will monitor the medication charts of study infants to ensure adherence to the intervention.
Sponsors
Princess Margaret Hospital for Children
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 4 Weeks
Healthy volunteers
No
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
Outcome results
None listed