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CompletedNCT03925558Updated Apr 25, 2019

Tolerance of a Probiotic Formula

An interventional study of Probiotics and Placebo in Safety Issues, sponsored by Probi AB. Completed. Open to participants aged 3 Days to 95 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-25.

Sponsored by Probi AB · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
3 Days to 95 Days
Sex
All
01

Study summary

Evaluate the tolerance of a probiotic formula in infants

02

Conditions studied

  • Safety Issues
03

Who can participate

Ages eligible
3 Days to 95 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Full term healthy infant aged 3-95 days

Exclusion criteria

Exclusion Criteria:

  • Prematurity
  • Low birth weight
  • Congenital anomalies
  • Chronic disease
  • Failure to thrive
  • Allergy or atopic disease
  • Recent exposure to antibiotics
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    Probiotic formula

    Lactobacillus strains

    Dietary Supplement: Probiotics

  • Placebo comparator
    Placebo formula

    Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementProbiotics
  • Dietary supplementPlacebo
05

What researchers measure

Primary outcomes

  1. Body weight (g)

    Time frame: 8 weeks

  2. Body length (cm)

    Time frame: 8 weeks

  3. Head circumference (cm)

    Time frame: 8 weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03925558
Lead sponsor
Probi AB
Responsible party
Sponsor
First posted
Apr 24, 2019
Start date
Apr 12, 2011
Primary completion
Dec 19, 2011
Completion
Dec 19, 2011
Last update
Apr 25, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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