Effects of Oral Probiotic Supplementation on the Clinical Status of Very-low-birth-weight Preterm Neonates.

NCT02073214 | Completed

• 1 other identifier: PB-DM/SBK-NEC-01/11
• Study Type: interventional
• Target: 182
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to evaluate the safety of a probiotic foodstuff and its influence on emergence and development of natural intestinal flora and the clinical status of premature very low birth weight neonates. The study was also intended to investigate reduction of colonisation by pathogenic bacteria and to estimate the incidence of gastrointestinal disorders. Probotic bacteria contained in the investigational product administered directly after birth are beneficial for the development of normal gut microflora and can prevent or significantly limit gastrointestinal colonisation by pathogenic bacteria and the development of pathogenic flora in a hospital setting. Permanent colonisation with commensal flora in very early life improves gastrointestinal function in premature neonates by reducing the onset of or by decreasing the severity of the signs and symptoms of feeding intolerance and generalised bacterial infections, including sepsis and necrotizing enterocolitis.

Conditions

Late Onset Neonatal Sepsis; Necrotizing Enterocolitis; Infant, Very Low Birth Weight

Outcome Measures

Primary Outcomes (3)

• Gastrointestinal tract colonisation

  Bacteriological tests involved quantitative and qualitative assessment of neonatal gut flora during clinical follow-up. Bacterial populations of Lactobacillus and Bifidobacterium as well as pathogenic bacteria were assesed. Stool samples were collected at 7-day intervals (±2 days) in the period of investigational product intake, and on Day 7 (±2 days) after the last dose of the investigational product.

  Assesed on days 1, 7, 14, 21, 28, 35, 42 and 49 (assesed weekly within eight weeks)

• Feeding intolerance episodes (including: gastric residuals, vomiting, regurgitation of food, abdominal distension, abdominal rigidity, gut motility disorders)

  Clinical parameters were evaluated throughout the period of care according to standard neonatal care procedures.

  Assesed on a daily basis (from 1 to 42 and on day 49)

• Incidence and type of adverse events and serious adverse events with special regard to sepsis caused by bacteria contained in investigational product.

  Safety was evaluated by determining whether investigational product in VLBW preterm neonates increases AE/SAE incidence and influences the type of adverse events and serious adverse events as compared to placebo with special regard to sepsis caused by bacteria contained in investigational product .

  Assesed on a daily basis (from 1 to 42 and on day 49)

Secondary Outcomes (9)

• Late onset sepsis caused by Gram positive or Gram negative bacteria

  Assesed on a daily basis (from 1 to 42 and on day 49)

• Gastrointestinal perforation

  Assesed on a daily basis (from 1 to 42 and on day 49)

• Duration of total parenteral nutrition (days)

  Assesed on a daily basis (from 1 to 42 and on day 49)

• Duration (days) of absence of enteral nutrition due to gastrointestinal disorders

  Assesed on a daily basis (from 1 to 42 and on day 49)

• Duration (days) of absence of enteral nutrition for reasons other than gastrointestinal disorders

  Assesed on a daily basis (from 1 to 42 and on day 49)

Study Arms (2)

Probiotic

EXPERIMENTAL

Single dose of probiotic, was administered enterally twice daily with food (in the morning and in the evening). The first dose of probiotic was administered within the first 48 hours after birth. The probiotic administration was continued for 6 weeks or until hospital discharge (whichever was earlier). Discontinuation of the enteral nutrition was equivalent with discontinuation of the administration of the probiotic. If the probiotic was discontinued for more than 7 days, the patient was withdrawn from the study.

Other: Probiotic

Placebo

PLACEBO COMPARATOR

Single dose of placebo was administered enterally twice daily with food (in the morning and in the evening). The first dose of placebo was administered within the first 48 hours after birth. The placebo administration was continued for 6 weeks or until hospital discharge (whichever was earlier). Discontinuation of the enteral nutrition was equivalent with discontinuation of the administration of the placebo. If the placebo was discontinued for more than 7 days, the patient was withdrawn from the study.

Other: Placebo

Interventions

Probiotic OTHER

Standard treatment plus probiotic

Also known as: Food for special medical purposes

Probiotic

Placebo OTHER

Standard treatment plus placebo

Placebo

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants ≥ 750 g and ≤ 1800 g at birth
• Gestational age of ≤ 34 weeks
• Mother's age ≥ 18 years
• Possibility of feeding by enteral route
• Possibility of enrolment ≤ 48 hours of age
• Caucasian race
• Parent-legal guardian informed consent obtained in writing

You may not qualify if:

• Infants \< 750 g and \> 1800 g at birth
• Gestational age of \> 34 weeks
• Mother's age \< 18 years
• Contraindicated to enteral nutrition within the first 48 hours of life
• Birth asphyxia (Apgar score: 0-3)
• Major congenital abnormalities, including gastrointestinal abnormalities
• Severe clinical condition / disorders which the Investigator considers a contraindication to study participation, including the presence of at least 3 out of 4 of the following symptoms:
• necessity of mechanical ventilation and FiO2 more than 0.6 elevation to maintain blood oxygen saturation within 88-93%,
• metabolic acidosis, pH less than 7.20 and BE more than (-10),
• necessity of vasopressor (antihypotensive) agents to maintain proper arterial blood pressure,
• signs of damage to at least one vital organ (liver, kidneys, gastrointestinal tract, adrenal glands).
• Administration of other probiotic preparations
• Enrolment in any other clinical trial throughout the study period
• Lack of parent-legal guardian informed consent

Sponsors & Collaborators

• IBSS Biomed S.A.: lead
• Ministry of Science and Higher Education, Poland: collaborator

MeSH Terms

Conditions

Neonatal Sepsis; Enterocolitis, Necrotizing

Interventions

Probiotics; Food

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ryszard Lauterbach, Prof., MD

  Jagiellonian University Medical College, Department of Neonatology, Kopernika 23 St., 31-501 Krakow, Poland

  PRINCIPAL INVESTIGATOR

• Aleksandra M Cichonska, PhD

  IBSS Biomed S.A.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: February 27, 2014
• Study Start: April 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 27, 2014

Record last verified: 2014-02