Probiotics for Prevention of Antibiotic Associated Diarrh... | NCT02076438

Studies
Probiotics for Prevention of Antibiotic Associated Diarrhea and Clostridium Difficile Associated Disease

NCT02076438

Sponsor

Rutgers, The State University of New Jersey

Status

Terminated

Last Update Posted

Nov 23, 2016Estimated

Enrollment

110Actual

Phase

Not Applicable

Conditions

Diarrhea

Interventions

Probiotics

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Grant# PC 14-13	Other Identifier	New Jersey Health Foundation

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of recruitment

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Jul 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Feb 25, 2014

First Submission Date that Met QC Criteria

Feb 28, 2014

First Posted Date

Mar 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2016

Last Update Posted Date

Nov 23, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amita Avadhani, DNP, DCC, ACNP, ANP, CCRN, Assistant Professor/Director Post MSN-DNP program, Rutgers, The State University of New JerseyPrincipal Investigator

Lead Sponsor

Rutgers, The State University of New JerseyOTHER

Collaborators

Name	Class
Saint Peters University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study will evaluate if administration of probiotic Culturelle (Lactobacillus Rhamnosus GG) along with antibiotics can help decrease the occurrence of diarrhea caused by antibiotics as well as Clostridium difficile Diarrhea.

Detailed Description

Inpatient adult males and females who are at least 18 years of age or older, undergoing treatment with antibiotics irrespective of indication and the type of antibiotics. The setting is an academic hospital.The patients are screened and potentially recruited upon initiation of antibiotic treatment regardless of indication for antibiotic prescription. The participants are patients being admitted to any inpatient units of the hospital for treatment with antibiotics. Exclusion criteria is:

Diarrhea on admission or within the preceding week
Reported recurrent diarrhea
Bowel pathology that could result in diarrhea (including preexisting Inflammatory Bowel disease{IBD}, all forms for colitis or any other condition resulting in preexisting diarrhea)
Intake of high risk antibiotics (clindamycin, cephalosporins, aminopenicillins→ well known to cause CDAD) and or more than two courses of other antibiotics in the past four weeks to exclude pre-existing diarrhea associated with antibiotic use
Immunosuppression (Chronic steroid use, Active chemotherapy, Active radiotherapy, HIV or any other disorder resulting in a compromise in participants immune status)
Bowel surgery causing liquid stools
Regular probiotic intake before admission
Lactose intolerance or intolerance to dairy products.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo capsules	Dietary Supplement: Probiotics
Probiotics	Experimental	Lactobacillus Rhamnosus GG 10 billion cfu BID	Dietary Supplement: Probiotics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotics	Dietary Supplement	Randomized to receive probiotics or placebo	Placebo Probiotics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diarrhea	Diarrhea associated with antibiotics	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Tolerability of probiotics	Patient experience with use of probiotics	4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inpatient adult males and females who are at least 18-89 years of age, undergoing treatment with antibiotics irrespective of indication and the type of antibiotics.

Exclusion Criteria:

Diarrhea on admission or within the preceding week
Reported recurrent diarrhea
Bowel pathology that could result in diarrhea (including preexisting Inflammatory Bowel disease{IBD}, all forms for colitis or any other condition resulting in preexisting diarrhea)
Intake of high risk antibiotics (clindamycin, cephalosporins, aminopenicillins→ well known to cause CDAD) and or more than two courses of other antibiotics in the past four weeks to exclude pre-existing diarrhea associated with antibiotic use
Immunosuppression (Chronic steroid use, Active chemotherapy, Active radiotherapy, HIV or any other disorder resulting in a compromise in participants immune status)
Bowel surgery causing liquid stools
Regular probiotic intake before admission
Lactose intolerance or intolerance to dairy products

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amita Avadhani, DNP	Rutgers University and Saint Peters University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saint Peters University Hospital		New Brunswick	New Jersey	08824	United States

Condition Browse Module

MeSH Terms

ID	Term
D003967	Diarrhea

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019936	Probiotics

Ancestor Terms

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided