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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Tolerance of a Probiotic Formula

Clinicaltrials.gov identifier NCT03925558

Recruitment Status Completed

First Posted April 24, 2019

Last update posted April 25, 2019

Study Description

Brief summary:

Evaluate the tolerance of a probiotic formula in infants

  • Condition or Disease:Safety Issues
  • Intervention/Treatment: Dietary Supplement: Probiotics
    Dietary Supplement: Placebo
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 36 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Other
  • Official Title: Tolerance of a Probiotic Formula Containing Lactobacilli
  • Actual Study Start Date: April 2011
  • Actual Primary Completion Date: December 2011
  • Actual Study Completion Date: December 2011
Arms and interventions
Arm Intervention/treatment
Active Comparator: Probiotic formula
Lactobacillus strains
Dietary Supplement: Probiotics
Placebo Comparator: Placebo formula
Placebo
Dietary Supplement: Placebo
Outcome Measures
  • Primary Outcome Measures: 1. Body weight (g) [ Time Frame: 8 weeks ]
  • 2. Body length (cm) [ Time Frame: 8 weeks ]
  • 3. Head circumference (cm) [ Time Frame: 8 weeks ]
Eligibility Criteria
  • Ages Eligible for Study: up to 95 / (64 years+)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- Full term healthy infant aged 3-95 days

Exclusion Criteria:

- Prematurity

- Low birth weight

- Congenital anomalies

- Chronic disease

- Failure to thrive

- Allergy or atopic disease

- Recent exposure to antibiotics

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Probi AB

More Information
  • Responsible Party: Probi AB
  • ClinicalTrials.gov Identifier: NCT03925558 History of Changes
  • Other Study ID Numbers: ProTolerance
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: April 25, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No