Prophylactic Probiotics to Extremely Low Birth Weight Prematures

NCT01603368 | Completed Phase 2 Results DMC

• 1 other identifier: Dnr 2012/28-31
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 2

Brief Summary

Mortality and incidence of severe complications is still high among extremely premature infants. Common causes of severe complications in this population are poor nutrition, necrotizing enterocolitis, and severe infections. Feeding intolerance is also a common problem resulting in prolonged need for intravenous lines and poor nutrition. The aim of the study is to evaluate whether supplementation with the probiotic bacterium Lactobacillus reuteri DSM 17938 daily to premature infants with extremely low birth weight increases feeding tolerance to breast milk and thereby improves nutrition, increases growth and reduces serious complications and mortality in this population. Beyond this, possible mechanisms underlying these effects will be analyzed in stool, breast milk and blood samples.

Conditions

Feeding; Difficult, Newborn; Growth Failure; Necrotizing Enterocolitis; Sepsis

Keywords

Probiotics; Lactobacillus reuteri; Prematures; Enteral feeding; Motility; Necrotizing enterocolitis; Sepsis; Weight

Outcome Measures

Primary Outcomes (1)

• Time to Establish Full Enteral Feeds

  The age of the infants in days when the infant receive 150 ml/kg/day via enteral feeding for the first time.

  Birth to gestational week 36+0

Secondary Outcomes (18)

• Days With Halted Feeding Due to Food Intolerance

  Birth to gestational week 36

• Number of Stools

  Recorded over the first four weeks

• Time Until Birth Weight is Regained. Specifies the Number of Full Days the Child Has Lived.

  Birth to gw 36+0

• Weight Gain (SD)

  At 14th day of life

• Mortality

  Birth to gw 36+0

Study Arms (2)

Lactobacillus reuteri

ACTIVE COMPARATOR

Lactobacillus reuteri DSM 17938, 125 million bacteria/day

Dietary Supplement: Lactobacillus reuteri

Placebo

PLACEBO COMPARATOR

The same oil drops as the active study product but without Lactobacillus reuteri

Dietary Supplement: Placebo

Interventions

Lactobacillus reuteri DIETARY_SUPPLEMENT

Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day

Lactobacillus reuteri

Placebo DIETARY_SUPPLEMENT

Oil drops without Lactobacillus reuteri

Placebo

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight \< 1000 g
• Gestational age: v23+0-V27 +6.
• Signed informed consent by parents.

You may not qualify if:

• Participation in another study which aims to influence nutrition, growth, feeding tolerance or necrotizing enterocolitis.

Sponsors & Collaborators

• Ostergotland County Council, Sweden: lead
• BioGaia AB: collaborator
• Ekhaga Foundation, Sweden: collaborator
• Medical Research Council of Southeast Sweden: collaborator
• University Hospital, Linkoeping: collaborator
• The Swedish Research Council: collaborator
• The Swedish Society of Medicine: collaborator

Study Sites (2)

Vrinnevi Hospital in Norrköping

Norrköping, 60379, Sweden

Location

Karolinska

Stockholm, SE-171 76, Sweden

Location

Related Publications (2)

• Spreckels JE, Wejryd E, Marchini G, Jonsson B, de Vries DH, Jenmalm MC, Landberg E, Sverremark-Ekstrom E, Marti M, Abrahamsson T. Lactobacillus reuteri Colonisation of Extremely Preterm Infants in a Randomised Placebo-Controlled Trial. Microorganisms. 2021 Apr 24;9(5):915. doi: 10.3390/microorganisms9050915.

  PMID: 33923278 DERIVED

• Marti M, Spreckels JE, Ranasinghe PD, Wejryd E, Marchini G, Sverremark-Ekstrom E, Jenmalm MC, Abrahamsson T. Effects of Lactobacillus reuteri supplementation on the gut microbiota in extremely preterm infants in a randomized placebo-controlled trial. Cell Rep Med. 2021 Feb 22;2(3):100206. doi: 10.1016/j.xcrm.2021.100206. eCollection 2021 Mar 16.

  PMID: 33763652 DERIVED

MeSH Terms

Conditions

Failure to Thrive; Enterocolitis, Necrotizing; Sepsis; Body Weight

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes

Results Point of Contact

• Title: Thomas Abrahamsson, MD PhD
• Organization: University of Linköping

thomas.abrahamsson@liu.se

+46.10.1030000

Study Officials

• Thomas Abrahamsson, MD, PhD

  Linköping University Hospital; County Council of Östergötland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Neonatologist

Study Record Dates

• First Submitted: May 18, 2012
• First Posted: May 22, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 13, 2024
• Results First Posted: April 27, 2020

Record last verified: 2024-07

Locations

SE (2)