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OpenTrials
Completed

NCT Number: NCT01822977

The Impact of Proton Pump Inhibitors on the Fecal Microbiome

The investigators hypothesis is that daily use of a proton pump inhibitor (PPI) is associated with significant alterations in the healthy fecal microbiome that are similar to those seen in persons with an initial episode of clostridium difficile infection (CDI).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Table 1. Inclusion Criteria for Healthy Volunteers:

  • Healthy individuals without chronic gastrointestinal problems or using antisecretory medications.

Table 2. Inclusion Criteria for Clostridium difficile infection subjects:

  • Newly diagnosed first episode of CDI prior to being treated.

Table 3. Exclusion Criteria for Healthy Subjects:

  • Prior gastrointestinal surgery that has altered the anatomy of the esophagus, stomach, or small/large intestine including appendectomy and cholecystectomy.
  • Chronic daily use of any medications that could alter gastrointestinal secretory or motor function (see Table 2).
  • Gastrointestinal, cardiovascular, endocrine, renal, or other chronic disease likely to affect gastrointestinal motility (e.g., uncontrolled diabetes mellitus).
  • Females of childbearing age who are not practicing at least one form of birth control at least one month prior to starting the PPI or are pregnant or lactating (a pregnancy test will be performed on female subjects prior to PPI use).
  • Significant untreated psychiatric disease.

Table 4. Prohibited Medications:

  • Antibiotics within 2 months of the stool sample collection.
  • Probiotics (e.g., Florastor, Align, Flora-Q, VSL#3, lactobacillus, bifidobacterium) within 2 weeks of the stool sample collection.
  • Fiber supplements (e.g., Metamucil, Citrucel, Benefiber), unless maintained on a stable dose for the last 3 months.
  • Chronic use of medications that alter gastric pH: proton pump inhibitors (e.g., omeprazole, lansoprazole, esomeprazole, pantoprazole, rabeprazole, dexlansoprazole) and histamine2 receptor antagonists (e.g., cimetidine, famotidine, ranitidine).
  • Chronic use of medications that affect gastrointestinal motility and/or transit including prokinetic agents (e.g., metoclopramide (Reglan), tegaserod (Zelnorm), domperidone (Motilium), erythromycin), narcotic analgesic agents (e.g., methadone, fentanyl, oxycodone, codeine, morphine, hydromorphone), laxatives including mineral oil, anticholinergic agents (e.g., Bentyl, Levsin), and antidiarrheal agents (e.g., Kaopectate (donnagel), Pepto-Bismol (bismuth subsalicylate), Imodium (loperamide), Lomotil (atropine with diphenoxylate), codeine, tincture of opium).

Treatment and study plan

Omeprazole

Drug

Primary outcomes

  1. Changes in fecal microbial diversity due to PPI therapy

    Time frame: 2 months

Secondary outcomes

  1. Changes in fecal microbial diversity due to CDI

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

The Impact of Proton Pump Inhibitors on the Fecal Microbiome and Their Relationship to Clostridium Difficile Infection

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 4, 2013
Registry last updated
Aug 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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