CompletedEarly Phase 1

Mechanisms of Probiotics and Antibiotic-Associated Diarrhea

United States118 participantsStarted 2021-01-01

Plain-language 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. 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: day 7

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

Timeframe: day 30

Trial details

NCT IDNCT04414722

SponsorGeorgetown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-01

Results submitted2024-11-21

View on ClinicalTrials.gov More Antibiotic-associated Diarrhea trials