The Influence of Probiotics on Vancomycin-Resistant Enterococcus

NCT00591474 | Terminated DMC

• 1 other identifier: IRB3848
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Drinking probiotics in a the form of a yogurt drink will restore normal gastrointestinal (GI) bacteria in patients whose colon are colonized with vancomycin-resistant enterococcus (VRE).

Conditions

GI Colonization of Vancomycin-resistant Enterococcus

Keywords

VRE; Probiotics; colonization; gut health

Outcome Measures

Primary Outcomes (1)

• Whether a positive VRE colonized patient becomes VRE negative after drinking yogurt with probiotics

  4 weeks

Secondary Outcomes (3)

• Time to VRE clearance

  4 weeks

• Sustainable effects of probiotics on VRE colonization

  8 weeks

• Any positive or negative effects on patients' hospital stay.

  8 weeks

Study Arms (2)

1

EXPERIMENTAL

VRE positive patients

Dietary Supplement: probiotics

2

PLACEBO COMPARATOR

VRE positive patients

Dietary Supplement: yogurt

Interventions

probiotics DIETARY_SUPPLEMENT

100 gms of a yogurt drink containing probiotics will be given to pVRE positive patients for 4 weeks

1

yogurt DIETARY_SUPPLEMENT

100 gms of pasteurized yogurt drinks with no live cultures will be given to VRE positive patients for 4 weeks

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• VRE positive patients with GI colonization

You may not qualify if:

• Age less than 18 years
• Patients who have had a bone marrow transplant
• Extreme short bowel patients (less than 100 cm small bowel remaining)
• Patients with active VRE infection but no GI colonization
• Patients unable to eat and have no feeding access
• Patients who do not have a power of attorney to give consent if they are unable to

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

OHSU hospital

Portland, Oregon, 97239, United States

Location

Related Publications (40)

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MeSH Terms

Interventions

Probiotics; Yogurt

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Cultured Milk Products; Milk; Beverages; Fermented Foods; Dairy Products

Study Officials

• Robert Martindale, MD, PH.D

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 11, 2008
• Study Start: December 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 4, 2019

Record last verified: 2019-05

Locations

US (1)