NCT01724203

Brief Summary

The purpose of this clinical trial is to evaluate the safety and effectiveness of 12-week probiotic supplementation on the incidence and duration of infectious episodes in infants aged 6 to 12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

October 11, 2013

Status Verified

October 1, 2013

Enrollment Period

4 months

First QC Date

November 7, 2012

Last Update Submit

October 10, 2013

Conditions

Effect of Probiotics on Infections in Infants.

Keywords

Probiotics for infantsBacterial and viral infections in infants

Outcome Measures

Primary Outcomes (1)

  • The proportion of subjects with one or more of confirmed bacterial or viral infections at any time during the study

    The primary endpoint of this clinical trial is the proportion of subjects with one or more of the following confirmed bacterial or viral infections at any time during the study: fever \> 37.5ºC (axillary), upper respiratory tract infection, lower respiratory tract infection, pneumonia, strep throat, diarrhea, and otitis media.

    12 weeks

Secondary Outcomes (7)

  • Cumulative days with infectious symptoms

    12 weeks

  • Cumulative number of infectious episodes

    12 weeks

  • Stool frequency

    12 weeks

  • Stool Consistency

    12 weeks

  • Infant Characteristics Questionnaire

    12 weeks

  • +2 more secondary outcomes

Study Arms (3)

Lactobacillus rhamnosus

ACTIVE COMPARATOR

Formula containing 1 million CFU/g Lactobacillus rhamnosus HN001 (trademarked DR20) at least three times daily for 12 weeks.

Dietary Supplement: Lactobacillus rhamnosus

Bifidobacterium animalis subsp. lactis

ACTIVE COMPARATOR

Formula containing 1 million CFU/g Bifidobacterium animalis subsp. lactis HN019 (trademarked DR10) at least three times daily for 12 weeks.

Dietary Supplement: Bifidobacterium animalis subsp. lactis

Placebo

PLACEBO COMPARATOR

Placebo formula without probiotics at least three times daily for 12 weeks.

Dietary Supplement: Placebo

Interventions

Lactobacillus rhamnosusDIETARY_SUPPLEMENT
Lactobacillus rhamnosus
Bifidobacterium animalis subsp. lactisDIETARY_SUPPLEMENT
Bifidobacterium animalis subsp. lactis
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age6 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age 6 to 12 months.
  • Known vaccination history.
  • Ability of the participant's parent or legal guardian to comprehend the full nature and purpose of the study including possible risks and side effects.
  • Parental or legal guardian's consent to the study and willing to comply with study procedures.

You may not qualify if:

  • Symptoms of any infection at screening.
  • History of ≥5 infections in the previous 2 months.
  • Lactose intolerance or unable to drink milk.
  • Leukopenia or leukocytosis.
  • Immunodeficient or use of immunosuppressive drugs.
  • Use of antibiotic and anti-inflammatory medications within the last 2 weeks.
  • Use of products containing prebiotics or probiotics within the last 2 weeks.
  • Use of low-lactose or lactose-free infant or follow-on formula within the last 2 weeks.
  • Hepatitis B or C.
  • Medications or supplements that may affect subject safety or confound study outcomes in the opinion of the investigator.
  • Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator.
  • Participation in another study with any investigational product within 3 months of screening.
  • Any other condition that, in the investigator's opinion, may preclude the subject's ability to safely complete the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

Related Publications (1)

  • Dekker J, Quilter M, Qian H. Comparison of two probiotics in follow-on formula: Bifidobacterium animalis subsp. lactis HN019 reduced upper respiratory tract infections in Chinese infants. Benef Microbes. 2022 Oct 4;13(4):341-354. doi: 10.3920/BM2022.0041. Epub 2022 Aug 25.

    PMID: 36004715DERIVED

Study Officials

  • Xiaoyang Sheng, Dr

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2012

First Posted

November 9, 2012

Study Start

December 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

October 11, 2013

Record last verified: 2013-10

Locations

CN(1)