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

NCT02076438 | Terminated DMC

• 2 other identifiers: Pro2012002450Grant# PC 14-13
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea

Keywords

antibiotics; diarrhea; c diff; Hospitalized patients

Outcome Measures

Primary Outcomes (1)

• Diarrhea

  Diarrhea associated with antibiotics

  4 weeks

Secondary Outcomes (1)

• Tolerability of probiotics

  4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo capsules

Dietary Supplement: Probiotics

Probiotics

EXPERIMENTAL

Lactobacillus Rhamnosus GG 10 billion cfu BID

Dietary Supplement: Probiotics

Interventions

Probiotics DIETARY_SUPPLEMENT

Randomized to receive probiotics or placebo

Also known as: Lactobacillus Rhamnosus GG 10 billion cfu bid

Placebo; Probiotics

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Saint Peters University Hospital: collaborator

Study Sites (1)

Saint Peters University Hospital

New Brunswick, New Jersey, 08824, United States

Location

MeSH Terms

Conditions

Diarrhea

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Amita Avadhani, DNP

  Rutgers University and Saint Peters University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor/Director Post MSN-DNP program

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: March 3, 2014
• Study Start: November 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 23, 2016

Record last verified: 2016-11

Locations

US (1)