Probiotics Reduce Incidence of Necrotizing Enterocolitis for Very Low Birth Weight Infants - Full Text View

Sponsored by:	China Medical University Hospital
Information provided by:	China Medical University Hospital
ClinicalTrials.gov Identifier:	NCT00540033

Purpose

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	Intervention	Phase
Enterocolitis, Necrotizing	Dietary Supplement: infloran	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets

U.S. FDA Resources

Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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, ]

Enrollment:	217
Study Start Date:	February 2005
Study Completion Date:	June 2007

Arms	Assigned Interventions
2: Experimental 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;

Arms

Assigned Interventions

2: Experimental

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;

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 3 Weeks
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided by China Medical University Hospital

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Lin HC, Hsu CH, Chen HL, Chung MY, Hsu JF, Lien RI, Tsao LY, Chen CH, Su BH. Oral probiotics prevent necrotizing enterocolitis in very low birth weight preterm infants: a multicenter, randomized, controlled trial. Pediatrics. 2008 Oct;122(4):693-700.

Study ID Numbers:	DMR94-IRB-14
Study First Received:	October 3, 2007
Last Updated:	October 4, 2007
ClinicalTrials.gov Identifier:	NCT00540033 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by China Medical University Hospital:

probiotics
necrotizing enterocolitis
preterm very low birth weight infants (VLBW)

Study placed in the following topic categories:

Body Weight
Birth Weight
Signs and Symptoms
Digestive System Diseases
Gastrointestinal Diseases
Necrotizing Enterocolitis

Acidophilus
Intestinal Diseases
Gastroenteritis
Enterocolitis, Necrotizing
Enterocolitis
Bifidobacterium

Additional relevant MeSH terms:

Body Weight
Birth Weight
Signs and Symptoms
Digestive System Diseases
Gastrointestinal Diseases

Intestinal Diseases
Gastroenteritis
Enterocolitis, Necrotizing
Enterocolitis

ClinicalTrials.gov processed this record on August 28, 2009