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Not yet recruiting NCT07054593

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

Phase I Interventional Healthy Subjects

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CapScan.
Who it may be relevant to
Registry conditions: Healthy Subjects. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-Label, Pilot Study Designed To Evaluate The Effect Of A Proton Pump Inhibitor On The Regional Composition Of The Gut Microbiota And Metabolic Profiles Of Health Volunteers Using The Capscan® Samplng Capsule

Overview

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.

Detailed 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.

Interventions

  • Device CapScan
    Gut sampling capsule

Primary outcome measures

  • Identification of the gut microbial taxa using DNA sequencing of the samples obtained from the CapScan devices [Time frame: 2 months]
  • Identification of the gut metabolites using liquid chromatography - mass spectrometry of the samples obtained from the CapScan devices [Time frame: 2 months]
Secondary outcome measures (2)
  • Detect changes in composition of gut microbial taxa using DNA sequencing in subjects before and after omeprazole treatment [Time frame: 2 months]
  • Detect changes in composition of gut metabolites using liquid chromatography - mass spectrometry in subjects before and after omeprazole treatment [Time frame: 2 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Silicon Valley Gastroenterology — Mountain View

Identifiers

NCT: NCT07054593 · EB02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗