Probiotics in the Reduction of Antibiotic Associated Diarrhea

NCT02589964 | Terminated Phase 1

• 1 other identifier: 13085
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The study will evaluate the effectiveness of probiotic therapy in reducing the incidence of antibiotic associated diarrhea (AAD) and Clostridium difficile associated diarrhea (CDAD) in pneumonia patients.

Conditions

Clostridium Difficile

Keywords

probiotics; antibiotic associated diarrhea; clostridium difficile

Outcome Measures

Primary Outcomes (1)

• Antibiotic Associated Diarrhea

  Subjects will be asked to keep a diary for 20 days after starting study treatment and will be contacted by a nurse approximately 21 days after starting study treatment

  21 days after starting study treatment

Secondary Outcomes (4)

• Length of stay

  during hospitalization up to 4 weeks

• Mortality

  During hospitalization up to 4 weeks

• Healthcare costs

  During hospitalization up to 4 weeks

• Clostridium difficile

  21 days after initiating study treatment

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days. The treatment is Florajen-3. The ingredients in Florajen-3 are: Lactobacillus acidophilus-over 7.5 billion Bifidobacterium lactis-over 6.0 billion Bifidobacterium longum-over 1.5 billion

Dietary Supplement: Florajen-3

Placebo

PLACEBO COMPARATOR

Placebo will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days. The ingredients in the placebo are: Rice maltodextrin

Other: Placebo

Interventions

Florajen-3 DIETARY_SUPPLEMENT

The probiotic treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days.

Also known as: probiotic

Probiotic

Placebo OTHER

The placebo treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to Good Samaritan Hospital
• Placed on pneumonia order set
• Age 18+

You may not qualify if:

• Patient with inadequate coherency to understand consent
• Active Diarrhea at admission
• Non-controlled intestinal disease
• Documented positive C. difficile infection within the 3 months before enrollment
• Antibiotic use at hospital admission
• Immunosuppressive therapy
• Pregnancy
• Allergic to ingredients in Florajen-3
• Allergic to ingredients in placebo
• Immunocompromised state including:
• HIV with a low CD4 count
• Active malignancy receiving chemotherapy
• Medications including long-term steroids (\>2 weeks), and disease modifying biologic agents
• Acquired immune deficiency
• Unable to take oral medication

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

TriHealth

Cincinnati, Ohio, 45244, United States

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

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

Study Officials

• Amita Buddhdev, MD

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Specialist

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: October 28, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 31, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)