Role of Probiotics for Prevention of NEC in Preterm VLBW Infants

NCT02650869 | Completed Phase 3 DMC

• 1 other identifier: SylhetMAG
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective randomized double-blind control trial is carrying out in the neonatal unit of Sylhet MAG Osmani Medical College Hospital, Sylhet between July 2012 to December 2015 with the diagnosis of preterm (\<33 weeks gestation) VLBW (birth weight \<1500g) and fulfilling the inclusion criteria (able to tolerate oral feed and survive beyond 48h of life) were included in this study. Babies with suspicion of clinical sepsis, presence of perinatal asphyxia, major congenital anomaly and babies who expired due to other neonatal illness were excluded. Gestation was assessed from history of last menstrual period and after birth by new Ballard scores. A study protocol was approved by the Institutional Ethics Committee of Sylhet M.A.G Osmani Medical College, Sylhet.

Conditions

Necrotizing Enterocolitis

Keywords

Necrotizing Enterocolitis; probiotics; very low birth weight

Outcome Measures

Primary Outcomes (1)

• Necrotizing Enterocolitis: Occurrence of NEC (stage II and III) by Modified Bell's classification

  The occurrence of NEC (stage II and III) by modified Bell's classification

  10 days

Secondary Outcomes (3)

• Enteral feeding

  10 days

• Hospital stay

  10 days

• weight in Kg

  10 days

Study Arms (2)

Standard care + Breast milk+ Probiotics

EXPERIMENTAL

The study group will be fed with probiotics at a dose of 3x109 CFU/day. (Cap TS6 probiotic + contain Bifidobacterium spp., Lactobacillus at 6x109 CFU = 6 billion CFU) dissolved with 6 ml of milk then give 3 ml (3 billion probiotics) once daily with breast milk from first feeding.

Dietary Supplement: Probiotics

Standard care

ACTIVE COMPARATOR

The control group will be given standard care without the addition of probiotics

Dietary Supplement: Breast milk

Interventions

Probiotics DIETARY_SUPPLEMENT

probiotics at a dose of 3x109 CFU/day. (Cap TS6 probiotic + contain Bifidobacterium spp., Lactobacillus at 6x109 CFU = 6 billion CFU manufactured by TENSALL BIO-TECH CO.LTD.Taiwan, distributed by Century Health Care, Bangladesh)

Also known as: TS 6 Probiotics

Standard care + Breast milk+ Probiotics

Breast milk DIETARY_SUPPLEMENT

Normal breast milk will be given as part of standard care

Standard care

Eligibility Criteria

• Age: 1 Week - 33 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All newborn infant preterm (\<33 weeks gestation to 28 weeks gestation) VLBW (birth weight \<1500gm to 1000 gm)
• Able to tolerate oral feed
• Informed consent by the parents or guardian

You may not qualify if:

• Evidence or suspicion of clinical sepsis before the baby is randomised
• Presence of perinatal asphyxia
• Presence of major congenital anomali
• Death within first week of life due to other neonatal illness

Sponsors & Collaborators

• Sylhet M.A.G.Osmani Medical College: lead

Related Publications (4)

• Sharma R, Tepas JJ 3rd, Hudak ML, Mollitt DL, Wludyka PS, Teng RJ, Premachandra BR. Neonatal gut barrier and multiple organ failure: role of endotoxin and proinflammatory cytokines in sepsis and necrotizing enterocolitis. J Pediatr Surg. 2007 Mar;42(3):454-61. doi: 10.1016/j.jpedsurg.2006.10.038.

  PMID: 17336180 BACKGROUND

• Forchielli ML, Walker WA. The effect of protective nutrients on mucosal defense in the immature intestine. Acta Paediatr Suppl. 2005 Oct;94(449):74-83. doi: 10.1111/j.1651-2227.2005.tb02159.x.

  PMID: 16214770 BACKGROUND

• Neish AS, Gewirtz AT, Zeng H, Young AN, Hobert ME, Karmali V, Rao AS, Madara JL. Prokaryotic regulation of epithelial responses by inhibition of IkappaB-alpha ubiquitination. Science. 2000 Sep 1;289(5484):1560-3. doi: 10.1126/science.289.5484.1560.

  PMID: 10968793 BACKGROUND

• Deshpande G, Rao S, Patole S. Probiotics for prevention of necrotising enterocolitis in preterm neonates with very low birthweight: a systematic review of randomised controlled trials. Lancet. 2007 May 12;369(9573):1614-20. doi: 10.1016/S0140-6736(07)60748-X.

  PMID: 17499603 BACKGROUND

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Interventions

Probiotics; Milk, Human

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Milk; Beverages; Dairy Products

Study Officials

• Prof. M. Monojjir Ali, FCPS

  Professor and Head, Department of Paediatrics, Sylhet M.A.G.Osmani Medical College

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: December 31, 2015
• First Posted: January 8, 2016
• Study Start: July 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 8, 2016

Record last verified: 2016-01