Effect of Proton Pump Inhibitors on Gut Microbiota Composition and Metabolites in Healthy Subjects Using CapScan

Launched by ENVIVO BIO INC · Jun 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a type of medicine called proton pump inhibitors (PPIs), which reduce stomach acid, might affect the bacteria and chemical processes in the gut of healthy people. To do this, researchers will use a special device called the CapScan capsule that collects samples from different parts of the digestive system. The study is currently not recruiting participants yet.

Adults between 18 and 85 years old who are generally healthy may be eligible to join, as long as they don’t have certain medical conditions like previous stomach or bowel surgeries, bowel blockages, or inflammatory bowel diseases. Women who can become pregnant will need to have a negative pregnancy test before joining and agree to use reliable birth control during the study. Participants will be asked to follow the study’s instructions carefully and provide informed consent. This study helps us better understand how PPIs might change the gut environment in people without existing health issues.

Gender

ALL

Eligibility 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