N/A
Completed N=60
Proton Pump Inhibitors and Dysbiosis in Cirrhosis
Cirrhosis · Healthy
Source: ClinicalTrials.gov NCT01458990 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Number of Patients With Overgrowth of Oral Microbiota in Their Stool After PPI Therapy Withdrawal or Initiation — 45; 15 Participants
Summary
The purpose of this study is to find out whether the use of medications that suppress acid in your stomach can change the composition of your bowel bacteria.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Overgrowth of Oral Microbiota in Their Stool After PPI Therapy Withdrawal or Initiation |
45; 15 | — |
| SECONDARY Number of Patients With Adverse Events During Initiation or Withdrawal of PPI Therapy |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria for PPI initiation study:
- Cirrhosis not on current PPI or acid suppressive therapy
- No systemic antibiotics or probiotics
Exclusion Criteria for PPI initiation study:
- On systemic antibiotics
- On PPI or acid suppression therapy already
- unable to give informed consent
- Allergy to proton pump inhibitors
Inclusion Criteria for PPI withdrawal study:
- Cirrhosis on current PPI for an FDA-unapproved indication
- No systemic antibiotics or probiotics
Exclusion Criteria for PPI withdrawal study:
- On systemic absorbable antibiotics
- On PPI or acid suppression therapy for an FDA-approved indication
- unable to give informed consent
- unwilling to withdraw PPI
Data sourced from ClinicalTrials.gov (NCT01458990). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.