NCT03925558

Brief Summary

Evaluate the tolerance of a probiotic formula in infants

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Shorter than P25 for not_applicable

Status
completed

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

April 12, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2011

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
Last Updated

April 25, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

April 17, 2019

Last Update Submit

April 23, 2019

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (3)

  • Body weight (g)

    8 weeks

  • Body length (cm)

    8 weeks

  • Head circumference (cm)

    8 weeks

Study Arms (2)

Probiotic formula

ACTIVE COMPARATOR

Lactobacillus strains

Dietary Supplement: Probiotics

Placebo formula

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

ProbioticsDIETARY_SUPPLEMENT
Probiotic formula
PlaceboDIETARY_SUPPLEMENT
Placebo formula

Eligibility Criteria

Age3 Days - 95 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \- Full term healthy infant aged 3-95 days

You may not qualify if:

  • Prematurity
  • Low birth weight
  • Congenital anomalies
  • Chronic disease
  • Failure to thrive
  • Allergy or atopic disease
  • Recent exposure to antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

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

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 24, 2019

Study Start

April 12, 2011

Primary Completion

December 19, 2011

Study Completion

December 19, 2011

Last Updated

April 25, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share