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Amoxicillin-clavulanate for Antibiotic-associated Diarrhea (OURBIOTIC Trial)

Phase < 1
Waitlist Available
Led By Daniel Merenstein, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 7, 14, 21, 30
Awards & highlights

OURBIOTIC Trial Summary

This trial is studying a yogurt probiotic to see if it can help prevent antibiotic-associated diarrhea.

Eligible Conditions
  • Antibiotic-associated Diarrhea

OURBIOTIC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7, 14, 21, 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7, 14, 21, 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in baseline diversity of bacterial species in fecal microbiota
Change in baseline number of bacterial species in fecal microbiota
Other outcome measures
Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)
Change in reported symptoms: diarrhea/stool frequency, loose stool, constipation, fever, flatulence, lack of appetite, pain, rash, vomiting, allergic reaction, dyspepsia, and nausea.

OURBIOTIC Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Amoxicillin-clavulanateExperimental Treatment1 Intervention
Amoxicillin-clavulanate 875 mg-125 mg oral tablet
Group II: Concurrent BB-12 yogurt and amoxicillin-clavulanateActive Control2 Interventions
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
Group III: BB-12 yogurt taken 4 hours after amoxicillin-clavulanateActive Control2 Interventions
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
Group IV: Concurrent control yogurt and amoxicillin-clavulanatePlacebo Group2 Interventions
Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
Group V: Control yogurt taken 4 hours after amoxicillin-clavulanatePlacebo Group2 Interventions
Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
2021
Completed Phase 4
~240

Find a Location

Who is running the clinical trial?

Penn State UniversityOTHER
354 Previous Clinical Trials
125,469 Total Patients Enrolled
1 Trials studying Antibiotic-associated Diarrhea
255 Patients Enrolled for Antibiotic-associated Diarrhea
Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,364 Total Patients Enrolled
2 Trials studying Antibiotic-associated Diarrhea
321 Patients Enrolled for Antibiotic-associated Diarrhea
National Center for Complementary and Integrative Health (NCCIH)NIH
831 Previous Clinical Trials
668,795 Total Patients Enrolled
1 Trials studying Antibiotic-associated Diarrhea
66 Patients Enrolled for Antibiotic-associated Diarrhea

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions are Concurrent BB-12 yogurt and amoxicillin-clavulanate regularly used to treat?

"BB-12 yogurt and amoxicillin-clavulanate are commonly used in tandem to treat communicable diseases, though it is also prescribed for some non-communicable illnesses like bronchitis, upper respiratory tract infection and septicemia."

Answered by AI

Does my profile meet the qualifications to partake in this research?

"This research project seeks 124 individuals with diarrheal symptoms, aged between 18 and 65. Admission into the study is contingent upon meeting these criteria."

Answered by AI

How many subjects are currently participating in this clinical trial?

"Affirmative, the information hosted on clinicaltrials.gov indicates that this research study is still in need of recruits and has been since January 1st 2021. As of June 27th 2022, 124 people are needed from a single medical centre."

Answered by AI

Has recruitment for this research initiative commenced?

"Confirmed, the records on clinicaltrials.gov declare that this medical study is seeking participants. This trial was launched on January 1st 2021 and its details were most recently updated on June 27th 2022. One location requires 124 patients to take part in the experiment."

Answered by AI

Does this experiment accept individuals older than 45 years of age?

"This medical trial is open to those over the age of consent and below 65 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Mechanisms of Probiotics and Antibiotic-Associated Diarrhea
Daniel Merenstein 2021. "Mechanisms of Probiotics and Antibiotic-Associated Diarrhea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04414722.
~32 spots leftby Apr 2025
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