NCT01143623

Brief Summary

The purpose of this study is to determine the dose response effect of probiotic capsules for the prevention of antibiotic-associated diarrhea (AAD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
510

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2010

Shorter than P25 for phase_2

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

May 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

September 20, 2011

Status Verified

September 1, 2011

Enrollment Period

1.2 years

First QC Date

June 11, 2010

Last Update Submit

September 19, 2011

Conditions

Antibiotic-associated Diarrhea

Keywords

antibioticdiarrheaprobiotic

Outcome Measures

Primary Outcomes (1)

  • Incidence of antibiotic-associated diarrhea

    5 weeks after antibiotic discontinuation

Study Arms (3)

Probiotic

ACTIVE COMPARATOR
Dietary Supplement: Probiotic

Probiotic-2

ACTIVE COMPARATOR
Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT

L. acidophilus, L. paracasei, B. lactis; 2.5 billion cfu capsule once per day

Probiotic
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 30-70 years
  • initiating antibiotic therapy
  • informed consent

You may not qualify if:

  • current diarrhea
  • life threatening illness
  • habitual probiotic use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Diarrhea

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 11, 2010

First Posted

June 14, 2010

Study Start

May 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 20, 2011

Record last verified: 2011-09

Locations

CN(1)