Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02127814
Other study ID # RES504803
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2010
Est. completion date December 31, 2017

Study information

Verified date January 2019
Source Case Western Reserve University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to find whether Lactobacillus reuteri prevents antibiotic-associated diarrhea and related Clostridium difficile infections. Subjects will be admitted from the University Hospitals Case Medical Center. They will be randomly assigned to an intervention group receiving L. reuteri or a placebo. Supplementation will occur during antibiotic treatment and for an additional 7 days after cessation of treatment. Data collection will occur at baseline, end of antibiotic use, 7 days after antibiotic cessation, and 21 days after antibiotic cessation. Primary data includes diarrhea instances. Secondary data includes severity of diarrhea, presence of C. difficile toxins, and presence of other GI symptoms.


Description:

The data being measured for this study include:

Primary outcome = incidence of diarrhea during and after treatment with antibiotics. An episode of diarrhea is defined as the discrete period between the time when stool output meets or exceeds three soft and unformed or watery bowel movements to the time when formed stools return, which must be at least 48 hours later.

Secondary variables:

1. severity of diarrhea measured as the discrete period between the time when stool output meets or exceeds 3 soft and unformed or watery bowel movements to the time when formed stools return.

2. frequency of stool samples positive for C. Difficile toxin A or B at baseline, when presenting with diarrhea during the study period, and at the follow-up 21 days post-antibiotic-treatment to detect possible clearance of C. Difficile, in patients ingesting L. reuteri versus placebo.

3. frequencies of other gastrointestinal symptoms at 1, 2, and 4 weeks, in the L. reuteri group versus placebo and assessed by the validated Gastrointestinal Symptom Rating Score.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date December 31, 2017
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Receiving antibiotics for not more than 48 hours prior to enrollment and free from diarrhea

- able to understand and sign informed consent and HIPPA

- available throughout the study period

- subjects should have the mental ability to understand and willingness to fulfill all the details of the protocol

Exclusion Criteria:

- three or more soft and unformed or watery stools per day at admission

- receiving chemotherapy or radiation therapy

- diagnosis of inflammatory bowel disease

- NPO without PO meds

- neutropenia (an absolute neutrophil count (ANC) of less than 1500/microL)

- HIV positive with a CD4+ T-lymphocyte count <400 per mcL blood

- requiring care in an intensive care unit

- status-post bowel resection during hospitalization

- patient's receiving antibiotics four weeks prior to hospitalization

- patient with severe life threatening illness or immunocompromised

- pregnancy

Study Design


Intervention

Dietary Supplement:
Lactobacillus reuteri
One chewable tablet of 1E8 CFU L. reuteri, once per day

Locations

Country Name City State
United States University Hospitals Case Medical Center Cleveland Ohio

Sponsors (2)

Lead Sponsor Collaborator
Case Western Reserve University BioGaia AB

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary diarrhea Instances of diarrhea 28+ days
Secondary Severity of diarrhea measured as the discrete period between the time when stool output meets or exceeds three soft and unformed or watery bowel movements to the time when formed stools return. 28+ days
Secondary Frequency of stool samples positive for C. difficile toxin A and B Frequency of stool samples positive for C. difficile toxin A and B at baseline, when presenting with diarrhea during the study period, and at the follow-up 21 days post antibiotic-treatment to detect possible clearance of C. difficile, in patients ingesting L. reuteri versus placebo. baseline, when presenting with diarrhea during the study period, and at the follow-up 21 days
Secondary Frequencies of other gastrointestinal symptoms Frequencies of other gastrointestinal symptoms at 1, 2 and 4 weeks, in the L. reuteri group versus placebo and assessed by the validated GSRS score (Gastrointestinal Symptom Rating Score). 1, 2 and 4 weeks
See also
  Status Clinical Trial Phase
Completed NCT02896244 - AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment
Recruiting NCT06071312 - FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach Phase 1/Phase 2
Recruiting NCT01973465 - Fecal Microbiota Therapy for Recurrent Clostridium Difficile Colitis N/A
Terminated NCT01048567 - Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly Phase 2
Completed NCT01066221 - Comparative Study of Three Different Testing Mechanisms for Clostridium Difficile N/A
Not yet recruiting NCT03586206 - Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection
Completed NCT02563106 - A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI Phase 2
Completed NCT02857582 - Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile Phase 2
Completed NCT02207140 - Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly Phase 0
Not yet recruiting NCT01942447 - Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis N/A
Active, not recruiting NCT01703494 - Fecal Transplant for Relapsing C. Difficile Infection Phase 2
Completed NCT01813500 - Host Immune Response to Clostridium Difficile Infection in Inflammatory Bowel Disease Patients N/A
Completed NCT01087892 - Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection N/A
Suspended NCT00591357 - Efficacy of Loperamide for C. Difficile Colitis and Other Diarrheal Diseases Associated With Antibiotic Therapy Phase 4
Recruiting NCT00377078 - Use of Recombinant Human Lactoferrin in Long-Term Care Patients With Feeding Tubes With Clostridium Difficile. N/A
Completed NCT02254967 - A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population Phase 4
Terminated NCT01775397 - A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System Phase 4
Terminated NCT03617172 - PROCLAIM -- Misoprostol in the Prevention of Recurrent CDI Prevent Recurrence of Clostridium Difficile Infection With Misoprostol Phase 2
Recruiting NCT05622721 - REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs
Completed NCT02437487 - SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI) Phase 2