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Probiotics Reduce Incidence of Necrotizing Enterocolitis for Very Low Birth Weight Infants

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ClinicalTrials.gov Identifier: NCT00540033
Recruitment Status : Terminated (terminated because of enough case number)
First Posted : October 5, 2007
Last Update Posted : October 5, 2007
Sponsor:
Information provided by:
China Medical University Hospital

Brief Summary:
We investigate the efficacy of probiotics in reducing the incidence and severity of necrotizing enterocolitis (NEC) for very low birth weight (VLBW) infants.A prospective, masked, multi-center randomized control trial will be conducted level III neonatal center to evaluate the beneficial effects of probiotics for NEC among VLBW (<1500 g) infants. VLBW infants who start to feed enterally are eligible and are randomized into 2 groups after parental informed consents were obtained. Infants in the study group are fed with Infloran (Lactobacillus acidophilus and Bifidobacterium bifidus) with breast or formula milk twice daily for 6 weeks. Infants in the control group are fed with breast or formula milk alone. The clinicians caring for the infants are blinded to the group assignment. The primary outcome measurement is death or NEC (≧stage 2).

Condition or disease Intervention/treatment Phase
Enterocolitis, Necrotizing Dietary Supplement: infloran Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 2 Study of Oral Probiotics Reduce the Incidence and Severity of Necrotizing Enterocolitis for Very Low Birth Weight Infants -Multi-Center Randomized Control Trial
Study Start Date : February 2005
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 2
Study arm was fed with probiotics as infloran 125mg/kg/dose twice daily by adding it to breast milk or mixed feeding (breast and formula) for 6 weeks; the control arm was fed with breast milk or mixed feeding without probiotics.
Dietary Supplement: infloran
Study group was fed with probiotics as infloran 125mg/kg/dose twice daily by adding it to breast milk or mixed feeding (breast and formula) for 6 weeks;

Dietary Supplement: infloran
Study group was fed with infloran [Lactobacilli acidophilus (CFU 109 NCDO 1748, obtained from the National Collection of Dairy Organisms)] and Bifidobacteria bifidum [(CFU 109, NCDO 1453 obtained from the National Collection of Dairy Organisms)]; Laboratorio Farmaceutico S.I.T S.r.I ITALY] 125mg/kg/dose twice daily by adding it to breast milk or mixed feeding (breast and formula) for 6 weeks;




Primary Outcome Measures :
  1. The primary outcome measurement was death or NEC (≧stage 2) [ Time Frame: From April 1, 2005 to May 30, 2007 ]

Secondary Outcome Measures :
  1. Secondary outcome were culture proved sepsis, chronic lung disease, periventricular leukomalacia (PVL) , weight gain per week, duration of TPN, lengthy of stay, cost effective analysis. [ Time Frame: From April 1, 2005 to May 30, 2007, ]


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Ages Eligible for Study:   up to 3 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Preterm VLBW infants (birth weight < 1500 gm) who are enterally fed are eligible for the trial.

Exclusion Criteria:

  • Preterm VLBW infants who have severe asphyxia (stage III), fetal chromosome anomalies, fetal cyanotic congenital heart disease, congenital intestine atresia, gastroschisis and omphalocele are excluded.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540033


Locations
Taiwan
Department of Pediatrics, Children Hospital, China Medical University, Taichung, Taiwan
Taichung,, Taiwan, 404
Sponsors and Collaborators
China Medical University Hospital
Investigators
Study Chair: HUNG-CHIH LIN, MD Department of Pediatrics, Children Hospital, China Medical University, Taichung, Taiwan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00540033     History of Changes
Other Study ID Numbers: DMR94-IRB-14
First Posted: October 5, 2007    Key Record Dates
Last Update Posted: October 5, 2007
Last Verified: October 2007

Keywords provided by China Medical University Hospital:
probiotics
necrotizing enterocolitis
preterm very low birth weight infants (VLBW)

Additional relevant MeSH terms:
Birth Weight
Enterocolitis
Enterocolitis, Necrotizing
Body Weight
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases