NCT01214473

Brief Summary

Neonatal sepsis (serious infection) continues to be one of the major causes of morbidity and mortality in the newborn period around the world. India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates. Sepsis accounts for 50% of deaths among community born (and 20% of mortality among hospital-born) infants. Closely linked with this is a burgeoning problem of antimicrobial resistance, which is increasingly restricting the therapeutic options for medical care providers. Friendly bacteria called "Probiotics" have been used in multiple infectious and inflammatory disease states in humans. Fructooligosaccharides are sugars found naturally in many fruits and vegetables and also in human breast milk. These sugars reach the colon undigested and serve as food for the friendly bacteria. The current study uses a probiotic preparation containing Lactobacillus plantarum and fructooligosaccharides as an attempt to prevent neonatal infections. Currently no conclusive data are available on the utility of probiotics in such conditions. If successful, such inexpensive preventive therapy can be made available to general public in resource poor countries. Similar preparations can also be used in the western world to prevent similar infectious conditions of the neonatal period, especially in preterm infants where sepsis continues to be a major cause of hospital stay and death.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,556

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

5 years

First QC Date

September 30, 2010

Last Update Submit

August 19, 2023

Conditions

Neonatal SepsisSepsisNeonatal Infections

Keywords

Clinical sepsisPneumoniaDiarrheaProbioticsSynbiotics

Outcome Measures

Primary Outcomes (1)

  • Clinical sepsis and/or death

    Incidence of clinical sepsis and/or death

    During the first 60 days of life

Secondary Outcomes (3)

  • Culture proven sepsis

    During the first 60 days of life

  • Other infections

    During the first 60 days of life

  • Weight gain

    During the first 60 days of life

Study Arms (2)

Probiotic group

EXPERIMENTAL

Once daily oral administration of a probiotic preparation (1 billion cells of Lactobacillus plantarum and 150 mg of fructooligosaccharides) for one week to newborn infants

Dietary Supplement: Synbiotics

Placebo

PLACEBO COMPARATOR

Once daily oral administration of maltodextrin for one week to newborn infants

Dietary Supplement: Maltodextrin

Interventions

SynbioticsDIETARY_SUPPLEMENT

Lactobacillus plantarum with fructo-oligosaccharide

Probiotic group
MaltodextrinDIETARY_SUPPLEMENT

Only maltodextrin as placebo

Placebo

Eligibility Criteria

Age1 Day - 3 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All newborn infants in the community \>24 hours and \<72 hours of age
  • g at birth
  • Breastfeeding begun by 24 hr of life
  • Able to tolerate oral feeds
  • Informed consent by parent or guardian

You may not qualify if:

  • Evidence or suspicion of clinical sepsis before the baby is randomized
  • Not on breast feeding by 24 hr
  • Inability to establish oral feeds (in case of maternal death or ailment)
  • Presence of major congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Advanced Research on Alternative Medicine

Bhubaneswar, Odisha, 751009, India

Location

Ispat General Hospital

Rourkela, Odisha, 769002, India

Location

MeSH Terms

Conditions

Neonatal SepsisSepsisPneumoniaDiarrhea

Interventions

Synbioticsmaltodextrin

Condition Hierarchy (Ancestors)

InfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesSigns and Symptoms, DigestiveSigns and Symptoms

Intervention Hierarchy (Ancestors)

PrebioticsDietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaProbioticsFood and Beverages

Study Officials

  • Pinaki Panigrahi, MD,PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2010

First Posted

October 5, 2010

Study Start

June 1, 2007

Primary Completion

June 1, 2012

Study Completion

November 1, 2013

Last Updated

August 23, 2023

Record last verified: 2023-08

Locations

IN(2)