NCT02722993

Brief Summary

To assess the effect of a probiotic product, when co-administered with antibiotics, on gastrointestinal symptoms following antibiotic treatment in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

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

Study Start

First participant enrolled

February 3, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2017

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

1.3 years

First QC Date

March 16, 2016

Last Update Submit

September 24, 2018

Conditions

Antibiotic-associated Diarrhea

Outcome Measures

Primary Outcomes (1)

  • Number of loose/watery stools

    19-26 days

Study Arms (2)

Probiotics

ACTIVE COMPARATOR
Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

ProbioticsDIETARY_SUPPLEMENT
Probiotics
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age1 Year - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children at the age of 1-11 years that have been prescribed antibiotic treatment.
  • Problems with loose stools during earlier antibiotic treatments.
  • Children whose parents or legal caregivers have signed the informed consent to participate in the study.

You may not qualify if:

  • Chronic intestinal disease, immunodeficiency or immunosuppressive treatment.
  • Chronic or acute diarrheal disease.
  • Known hypersensitivity to any of the ingredients in the probiotic product or the placebo (potato starch ± bacterial culture that may contain traces of soy).
  • Patient requiring hospitalisation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Warsaw, Poland

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Piotr Socha, Prof.

    Children's Memorial Health Institute, Warzaw, Poland

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 16, 2016

First Posted

March 30, 2016

Study Start

February 3, 2016

Primary Completion

May 8, 2017

Study Completion

May 8, 2017

Last Updated

September 26, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)