Safety of D-lactate Producing Probiotics

NCT01119170 | Completed

• 1 other identifier: 09.51.INF
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators want to test the safety of D-lactate producing probiotics in babies from birth to 1 month of age. Previous data demonstrated no increase in urinary D-lactate in 4 month old infants supplemented with D-lactate producing probiotics. The primary purpose of this study is to evaluate the influence of D-lactate producing probiotics on D-lactate excretion in young infants during the neonatal period (days 0 - 28).

Conditions

Acidosis

Keywords

nutrition; infant formula; probiotics

Outcome Measures

Primary Outcomes (1)

• D-lactic acid urine measure in babies

  1 month

Secondary Outcomes (1)

• anthropometric measures (Weight, length, and head circumference, stool microbiota, adverse events

  6 months

Study Arms (2)

control starter formula

PLACEBO COMPARATOR

Other: Starter formula

D-lactate probiotics

EXPERIMENTAL

Other: starter formula with D-lactate producing probiotics

Interventions

Starter formula OTHER

standard starter formula given from birth to 6 months of age

control starter formula

starter formula with D-lactate producing probiotics OTHER

starter formula containing probiotics given from birth to 6 months of age

D-lactate probiotics

Eligibility Criteria

• Age: 1 Hour - 1 Day
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy babies, full term (≥37 weeks gestation) who are 0-24 hours of age at enrolment.
• Babies anticipated to be exclusively formula-fed.
• Babies under the care of a paediatrician or other qualified healthcare professional and have had at least one postnatal visit.
• Study explained and written information provided to Parent/Caregiver demonstrating understanding of the given information.
• Informed consent signed (parent/legal representative)

You may not qualify if:

• Babies with chromosomal or major congenital anomalies.
• Significant pre natal and/or post natal disease
• Babies receiving an antibiotic
• Babies born from mothers using supplemental probiotics during the last trimester of pregnancy and/or antibiotics during the last 14 days of pregnancy.
• Babies' family, of whom in the investigator's assessment, cannot be expected to comply with the protocol.
• Babies currently participating in another clinical study

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Maternity Helena Venizelou

Athens, Greece

Location

Related Publications (1)

• Garcia Rodenas CL, Lepage M, Ngom-Bru C, Fotiou A, Papagaroufalis K, Berger B. Effect of Formula Containing Lactobacillus reuteri DSM 17938 on Fecal Microbiota of Infants Born by Cesarean-Section. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):681-687. doi: 10.1097/MPG.0000000000001198.

  PMID: 27035371 DERIVED

MeSH Terms

Conditions

Acidosis

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

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

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: May 7, 2010
• Study Start: May 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 25, 2012

Record last verified: 2012-04

Locations

GR (1)