The Impact of Proton Pump Inhibitors on the Fecal Microbiome

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01822977

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Healthy Clostridium Difficile Infection	Drug: omeprazole	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Proton pump inhibitor 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

Arm

Intervention/Treatment

No Intervention: Proton pump inhibitor

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

Outcome Measures

Primary Outcome Measures

Changes in fecal microbial diversity due to PPI therapy [2 months]

Secondary Outcome Measures

Changes in fecal microbial diversity due to CDI [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).