The Impact of Proton Pump Inhibitors on the Fecal Microbiome

NCT01822977 | Completed Phase 1

• 1 other identifier: 13-000180
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy; Clostridium Difficile Infection

Keywords

gut microbiota; proton pump inhibitor; Clostridium difficile infection; Fecal microbiome; single episode of CDI

Outcome Measures

Primary Outcomes (1)

• Changes in fecal microbial diversity due to PPI therapy

  2 months

Secondary Outcomes (1)

• Changes in fecal microbial diversity due to CDI

  2 months

Study Arms (1)

Proton pump inhibitor

NO INTERVENTION

We will recruit 10 healthy adult individuals and 5 adult patients with an initial episode of CDI cared for at Mayo Clinic in Arizona. A baseline stool sample will be collected from the healthy individuals. They will then be given a PPI, omeprazole 20 mg, to be taken once (n=5) or twice (n=5) daily for 1 month. Stool samples will be collected after 1 week and again after 1 month. A final stool sample will be collected 1 month after stopping the omeprazole. A stool sample will be collected from the CDI subjects before treatment of the infection and again 2 months after treatment to avoid enrolling those at risk for relapse (which most commonly occurs during the first 2 months after treatment).

Drug: omeprazole

Interventions

omeprazole DRUG

Proton pump inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Healthy individuals without chronic gastrointestinal problems or using antisecretory medications.
• \. Newly diagnosed first episode of CDI prior to being treated.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Clostridium Infections

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• John Di Baise, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: April 4, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

US (1)