Proton Pump Inhibitor Impact on Gut Microbiota and Metabolic Profiles in Healthy Volunteers
This study observes how a Proton Pump Inhibitor affects the gut microbiota and metabolic profiles in healthy volunteers. We will identify key bacteria and metabolites in your gut using DNA sequencing and liquid chromatography-mass spectrometry.
Data Collection
Basic Science Study
Summary
Study start date: December 1, 2025
Actual date on which the first participant was enrolled.This study investigates how proton pump inhibitors (PPIs), a type of medication often used to reduce stomach acid, affect the bacteria and metabolic processes in the stomach and intestines of healthy individuals. Understanding these effects is important because the gut microbiome plays a crucial role in overall health, and changes in its composition can influence various bodily functions. By focusing on healthy volunteers, this research aims to gather basic scientific knowledge that could potentially lead to improved understanding of gut health and the impact of medications like PPIs. Participants in the study will take part in a trial where they use a special device called the CapScan capsule to collect samples from different regions of their gut. This capsule is swallowed and collects data as it travels through the digestive system. The study does not involve randomization, meaning every participant receives the same treatment and there is no placebo group. The main goal is to observe how the PPIs change the gut bacteria and metabolic profiles, providing valuable insights into the gut's response to these medications without focusing on direct health benefits or risks since this is an early phase study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.44 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
INCLUSION CRITERIA Subjects must meet all of the following criteria to be included in the study: * Males or females 18 years of age or older and 85 years of age or younger at the time of the first Screening Visit. * ASA Classification 1 or 2. * For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit. Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence). * Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form. EXCLUSION CRITERIA Subjects with any of the following conditions or characteristics must be excluded from the study: * History of any of the following: * prior gastric or esophageal surgery, including bariatric surgery * bowel obstruction * gastric outlet obstruction * gastroparesis * acute diverticulitis * inflammatory bowel disease * ileostomy or colostomy * gastric or esophageal cancer * achalasia * active dysphagia or odynophagia * Daily PPI use in the last 30 days * Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding * Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study * A clinical condition that, in the judgment of the investigator, could potentially pose a health risk to the subject while involved in the study
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Silicon Valley Gastroenterology
Mountain View, United StatesOpen Silicon Valley Gastroenterology in Google Maps