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Proton Pump Inhibitors and Gut Health Study

This study is looking at how proton pump inhibitors (PPIs), a common type of medication, affect the bacteria (microbiota) and other substances (metabolites) in your gut. Researchers will use a special capsule called CapScan to collect samples from your gut. The study aims to identify changes in these gut bacteria and metabolites after taking PPIs. You can join if you are a healthy adult between 18 and 85 years old. The study will be considered successful if it can identify the types of gut bacteria and metabolites present after two months. The current recruitment status is unclear.

Study design
This is an open-label, single-arm study, meaning all 44 participants will receive the same intervention and everyone will know what treatment is being given. It is not randomized, and it will be conducted at a single location.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements for gut bacteria and metabolites will be taken at 2 months.

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NCT07054593

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

Not Yet Recruiting
PHASE1Ages 18–85InterventionalBasic science
Envivo Bio Inc
~44 participants
Updated 2025-07-08 on ClinicalTrials.gov
What's tested:CapScan

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Identification of the gut microbial taxa using DNA sequencing of the samples obtained from the CapScan devices
Measured over 2 months
+1 more outcome measured

Conditions

Healthy Subjects

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Healthy Subjects

Where it's being run

1 sites across 1 states
California1

Who to contact

Jennifer Taufui
[email protected]
650-988-7530
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Identification of the gut microbial taxa using DNA sequencing of the samples obtained from the CapScan devices2 months

    A primary endpoint is to identify and quantitate the relative abundance of the gut microbial taxa using at least 3 million metagenomic DNA sequencing reads in at least 75% of the samples obtained from the CapScan devices.

  • Identification of the gut metabolites using liquid chromatography - mass spectrometry of the samples obtained from the CapScan devices2 months

    A primary endpoint is to identify at least 1,500 annotated gut metabolites from the intestinal tract in at least 75% of the samples obtained from the CapScan devices.