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Antibiotic-associated DiarrheaEarly Phase 1OURBIOTICNCT04414722

Mechanisms of Probiotics and Antibiotic-Associated Diarrhea

A Early Phase 1 study testing Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet and BB-12 in people with Antibiotic-associated Diarrhea, run by Georgetown University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The focus of the study is to better understand the mechanisms causing antibiotic-associated diarrhea (AAD) and how probiotics may prevent some of the iatrogenic effects of antibiotic medications. One of the most common indications for probiotics is for prevention of antibiotic-associated diarrhea. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Antibiotic-associated Diarrhea
What is being tested?
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet and BB-12
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
118 participants
Where
1 siteUnited States
Study dates
1 Jan 2021to 1 May 2023
Phase
Early Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Has the ability to read, speak, and write in English
  • Has a refrigerator (for proper storage of the study yogurt)
  • Has reliable telephone access
  • Is between ages of 18-65 years
  • Agree to refrain from eating yogurts, yogurt drinks, and other foods specified in the provided list
  • Agree to collect stool samples and participate in follow-up calls as specified

Who cannot join

  • Diabetes or asthma that requires medication
  • Allergy to strawberry
  • Active diarrhea (three or more loose stools per day for two consecutive days)
  • Any gastrointestinal (or digestive tract) medications, i.e. medicines for irritable bowel syndrome, gastroesophageal (acid) reflux disease, inflammatory bowel disease, etc.
  • History of heart disease, including valvulopathies or cardiac surgery, any implantable device or prosthetic
  • History of gastrointestinal surgery or disease
Show all 13Show fewer
  • Lactose intolerance that prevents participant from eating yogurt
  • Allergy to milk-protein
  • Allergy to any component of the product or the yogurt vehicle
  • Allergy to penicillin or cephalosporin class antibiotics
  • Allergy to any of the following medications: a) Penicillin; b) Erythromycin; c) Tetracycline; d) Trimethoprim; e) Ciprofloxacin
  • Women who are breastfeeding, pregnant, or planning to become pregnant during the study
  • Was a participant in the "YOBIOTIC" study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Georgetown University Department of Family Medicine

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: Exploratory Pilot Studies to Demonstrate Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics

The focus of the study is to better understand the mechanisms causing antibiotic-associated diarrhea (AAD) and how probiotics may prevent some of the iatrogenic effects of antibiotic medications. One of the most common indications for probiotics is for prevention of antibiotic-associated diarrhea. Clinically, different probiotic strains have demonstrated the ability to prevent AAD; however, the mechanism of action behind this effect has not been elucidated. Data from several studies suggest that antibiotic-induced disruption of commensal bacteria in the colon results in a significant (up to 50%) reduction in short chain fatty acid (SCFA) production and a concomitant reduction in Na-dependent fluid absorption resulting in AAD. Probiotics have been shown to ameliorate a variety of gastrointestinal disease states and thus, the study investigators hypothesize that administration of a probiotic yogurt will protect against the development of AAD.

Read the detailed description

Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. One of the most common indications for probiotic treatment is the prevention of antibiotic-associated diarrhea (AAD). Unfortunately, the efficacy of many probiotic products used for AAD is not supported by rigorous independent research, and non-evidence-based clinical usage is common. Data from several studies are consistent with the notion that antibiotic-induced disruption of commensal bacteria in the colon results in a significant reduction of short chain fatty acid (SCFA) production and a concomitant reduction in Na-dependent fluid absorption resulting in AAD. The probiotic strain being studied, Bifidobacterium animalis subsp. lactis BB-12 (BB-12), has been shown to ameliorate a variety of gastrointestinal disease states and is known to produce acetate at concentrations up to 50 mM in vitro. Thus, the investigators hypothesize that administration of BB-12 at the same time as antibiotic consumption will protect against the development of AAD through its ability to generate acetate directly, and also increase other SCFAs through cross-feeding of certain bacteria in the Firmicutes phylum such Clostridium, Eubacterium and Roseburia, which use acetate to produce butyrate.

The primary aim is to determine the ability of BB-12 to impact antibiotic-induced reduction in SCFA as reflected by the levels of acetate, the most abundant primary colonic SCFA, and assess temporal intervals of probiotic administration. The primary hypothesis is that antibiotics will result in a reduction in fecal SCFA, but BB-12 supplementation will protect against antibiotic-induced SCFA reduction and/or be associated with a more rapid return to baseline SCFA levels as compared to controls. Antibiotics also result in a decrease in total microbial counts and diversity in the gut microbiota, disrupting the homeostasis of the gut ecosystem and allowing colonization by pathogens. We hypothesize that concurrent administration of the probiotic and antibiotic is not necessary for the probiotic impact on SCFA.

The secondary aim will be to determine the ability of BB-12 to impact antibiotic-induced disruption of the gut microbiota with 16S ribosomal ribonucleic acid (rRNA) profiling, and assess temporal intervals of probiotic administration. The secondary hypothesis is that antibiotics will result in a decrease in the overall number and diversity of bacterial species present in the fecal microbiota, and further BB-12 supplementation will protect against antibiotic-induced shifts in the microbiota and/or will be associated with a more rapid return to a baseline microbiota composition as compared to controls. We hypothesize that concurrent administration of the probiotic and antibiotic is not necessary for the probiotic effect on the composition of the gut microbiota.

The tertiary aim is to longitudinally characterize the gut microbiota with high-throughput metatranscriptomics in order to generate complementary information on the impact of antibiotics plus and minus BB-12 on overall microbiome function. We hypothesize that acetate produced by BB-12 in situ will cross-feed butyrate producers in the Firmicutes phylum resulting in an up-regulation of butyrate biosynthetic pathways.

The long-term goal is to determine the impact of BB-12 on a variety of gastrointestinal disease states and ages, through high-level independent research. This mechanism elucidation is important for directing future translational and effectiveness research.

Being tested
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet, BB-12, Control Yogurt

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amoxicillin-Clavulanate 875 Mg-125 Mg Oral TabletDrug

    Also called Augmentin, Amoxicillin/clavulanic acid

    Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet

  • BB-12Biological

    Also called Bifidobacterium animalis subsp. lactis, BB-12

    Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt

  • Control YogurtOther

    Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12)

Study groups in NCT04414722
Study groupRoleWhat they receive
Concurrent control yogurt and amoxicillin-clavulanatePlacebo comparatorYogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
Receives: Drug: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet; Other: Control Yogurt
Control yogurt taken 4 hours after amoxicillin-clavulanatePlacebo comparatorYogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
Receives: Drug: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet; Other: Control Yogurt
Concurrent BB-12 yogurt and amoxicillin-clavulanateActive comparatorBifidobacterium animalis subsp. lactis BB-12-supplemented yogurt and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
Receives: Drug: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet; Biological: BB-12
BB-12 yogurt taken 4 hours after amoxicillin-clavulanateActive comparatorBifidobacterium animalis subsp. lactis BB-12-supplemented yogurt taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
Receives: Drug: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet; Biological: BB-12
Amoxicillin-clavulanateOtherAmoxicillin-clavulanate 875 mg-125 mg oral tablet
Receives: Drug: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline Levels of Fecal Short-chain Fatty Acid (With a Particular Focus on Acetate)

    Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)

    Measured: day 7

  2. Change From Baseline Levels of Fecal Short-chain Fatty Acid (With a Particular Focus on Acetate)

    Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)

    Measured: day 30

Secondary outcomes (2)
  1. Percentage Change in Baseline Diversity of Bacterial Species in Fecal Microbiota

    Percentage Change in Baseline Diversity of Bacterial Species in Fecal Microbiota (based on the Shannon Diversity Index, percentage of change):

    This outcome measures the percentage change in baseline diversity of bacterial species in the fecal microbiota, using the Shannon Diversity Index. Percent change within each treatment group was calculated comparing the Shannon diversity index at each follow-up day (i.e., day 7) to day 0 (baseline). The Shannon Diversity Index is a commonly used method to quantify microbial diversity, incorporating both the richness (the number of different species) and evenness (the distribution of species) within a sample. A positive percentage change reflects an increase in microbial diversity, while a negative percentage change indicates a decrease in microbial diversity compared to the microbial diversity at baseline.

    Measured: day 7

  2. Percentage Change in Baseline Diversity of Bacterial Species in Fecal Microbiota

    Percentage Change in Baseline Diversity of Bacterial Species in Fecal Microbiota (based on the Shannon Diversity Index, percentage of change):

    This outcome measures the percentage change in baseline diversity of bacterial species in the fecal microbiota, using the Shannon Diversity Index. Percent change within each treatment group was calculated comparing the Shannon diversity index at each follow-up day (i.e., day 14) to day 0 (baseline). The Shannon Diversity Index is a commonly used method to quantify microbial diversity, incorporating both the richness (the number of different species) and evenness (the distribution of species) within a sample. A positive percentage change reflects an increase in microbial diversity, while a negative percentage change indicates a decrease in microbial diversity compared to the microbial diversity at baseline.

    Measured: day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start1 Jan 2021
  3. Primary completion1 May 2023
  4. Study completion1 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04414722
Sponsor's protocol ID
2020-2431
Other IDs
R33AT009622
Acronym
OURBIOTIC
Status last verified
Feb 2025
First submitted
1 Jun 2020
Last updated
25 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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