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

Envivo Bio

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Subjects

Treatments: Device: CapScan

Study type: Interventional

Funder types: Industry

Identifiers

NCT07054593

EB02

Details and patient eligibility

About

This study is designed to evaluate the effect of proton pump inhibitors on the regional composition of the gut microbiota and metabolic profiles of health volunteers using the CapScan collection capsule.

Full description

Prospective, open-label, single-arm, non-randomized, single-center study designed to evaluate the effect of proton pump inhibitors on the regional composition of the gut microbiota and metabolic profiles of health volunteers using the CapScan collection capsule.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)