The Effects of Lactobacillus Reuteri DSM 17938 on Immunomodulation and Gastric Motility in Preterm Newborns

NCT00985816 | Completed Early Phase 1

• 1 other identifier: FI-LR2009
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose a Phase II interventional trial to investigate the role of Lactobacillus reuteri DSM 17938 on the intestinal motility and immune response of premature infants and further evaluate safety of the use of this probiotic in a population of premature infants.

Conditions

Preterm Birth

Keywords

Preterm; newborns; Gastric; Motility; Mucosal; immunity

Outcome Measures

Primary Outcomes (1)

• Evaluate the effects of L. reuteri in the intestinal motility by measuring the gastric emptying rate in infants before and after 21 consecutive days of administration of L. reuteri

  21 days

Secondary Outcomes (1)

• Mechanisms of action of L.reuteri

  21 days

Study Arms (2)

L reuteri DSM 17938

ACTIVE COMPARATOR

L. reuteri DSM 17938 will be given at a dose of 1x108 colony forming units (CFU)/day in an oil formulation delivered from a drop bottle. In the active study product, freeze-dried L. reuteri is suspended in a mixture of pharmaceutical grade medium chain triglycerides and sunflower oil together with pharmaceutical grade silicon dioxide to give the product the correct rheological properties (Connolly, 2005). The placebo consists of an identical formulation except that the L. reuteri is not present. This dose of the oil formulation with L. reuteri has been shown to induce significant colonisation in infants and is well-tolerated (Abrahamsson et al., 2007; Savino et al., 2007; Indrio et al., 2008).

Dietary Supplement: Lactobacillus Reuteri

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Lactobacillus Reuteri DIETARY_SUPPLEMENT

L. reuteri DSM 17938 will be given at a dose of 1x108 colony forming units (CFU)/day

L reuteri DSM 17938

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 3 Days - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age 30 - 32 weeks. Gestational age will be defined by the best estimate based on prenatal ultrasound in the first trimester, DLM and/or Balard Score after birth.

You may not qualify if:

• Cardiovascular or (respiratory) instability after 48 hours of age - Chromosomal anomalies.
• Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia)
• Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention
• Parental refusal
• Prior enrollment into a conflicting clinical trial. Conflicting clinical trial will be those in which the intervention could modify the outcome of the present study, for example studies that could alter the intestinal motility or the immune response of the premature infants.

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Flavia Indrio

Bari, Italy

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Flavia Indrio

  University of Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 25, 2009
• First Posted: September 28, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 8, 2011

Record last verified: 2009-09

Locations

IT (1)