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WithdrawnNCT01596153Updated Nov 18, 2014

Probiotics in Hospitalized Patients Study

An interventional study of Go Live in Antibiotic Associated Diarrhea and Clostridium Difficile Associated Diarrhea, sponsored by South Shore Hospital. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-18.

Sponsored by South Shore Hospital · Not applicable and Interventional

Why this study was withdrawn
The study was not initiated
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to compare the effect of enhanced probiotic (EP, Live Rx) versus placebo (PL) on the incidence of Clostridium difficile associated diarrhea (CDAD) or antibiotic associated diarrhea (AAD) in hospitalized patients initiated on antibiotics.

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Conditions studied

  • Antibiotic Associated Diarrhea
  • Clostridium Difficile Associated Diarrhea

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03

In context

Diarrhea

852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.

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Lead sponsor

South Shore Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18 years of age or older admitted to SSH and prescribed antibiotics for an expected duration >3 days (may include patients on antibiotics prior to admission).

Exclusion criteria

Exclusion Criteria:

    1. History of chronic diarrhea illness (Irritable Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), Celiac Disease, Chronic pancreatitis 2. Diarrhea at screening 3. Active Colitis of any etiology 4. History of colectomy 5. Regular consumption of probiotics within 72 hours 6. Unable to provide written consent 7. History of or active pancreatitis 8. Severe Sepsis or Septic Shock (sepsis with end organ failure e.g. renal failure, ARDS, MS changes and or meets criteria by n ational guideline, and or requiring vasopressors) 9. Hypersensitivity to any ingredient in probiotic product 10. Severe Immunosuppression (ANC \<1000, AIDS/CD4 count \<200 cells, cancer on active chemothereapy, h/o of solid or bone marrow transplant) 12. Acute burn injuries
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Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    BID

    Dietary Supplement: Go Live

  • Active comparator
    Go Live Rx Probiotic

    BID

    Dietary Supplement: Go Live

Interventions

  • Dietary supplementGo Live

    Enhanced Probiotic, one packet bid until 7 days after discontinuation of antibiotic

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What researchers measure

Primary outcomes

  1. Incidence of Clostridium difficle associated diarrhea in patients randomized to Go Live Rx compared with those randomized to placebo

    Time frame: 60 days after hospitalization

Secondary outcomes

  1. Incidence of Antibiotic associated diarrhea in patients randomized to Go Live Rx compared with those randomized to placebo

    Time frame: 60 Days after hospitalization

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01596153
Lead sponsor
South Shore Hospital
Responsible party
Sponsor
First posted
May 10, 2012
Last update
Nov 18, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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