Recruiting
Phase 1

Microbiome Sampling

Sponsor:

Envivo Bio Inc

Code:

NCT06298409

Conditions

Small Intestinal Bacterial Overgrowth

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CapScan collection capsule

Study Details

Brief summary:

We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO)

Conditions

Small Intestinal Bacterial Overgrowth

Study ID

NCT06298409

Start date

Feb 15, 2024

Status verified date

Jun, 2025

Completion date

Feb 28, 2026

Anticipated

Primary completion date

Feb 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Males or females 18 years of age or older and 80 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.
  • Positive for at least one clinical symptom consistent with SIBO.
  • Positive lactulose breath test for SIBO, by Hydrogen (H2) criteria.
  • Prescribed, but has not started, a two-week course of Rifaximin for SIBO.

Exclusion Criteria:

  • History of any of the following: Prior gastric or esophageal surgery, including lap banding or bariatric surgery, bowel obstruction, gastric outlet obstruction, diverticulitis, inflammatory bowel disease, ileostomy or colostomy, gastric or esophageal cancer, achalasia, esophageal diverticulum, active dysphagia or odynophagia.
  • Actively taking a proton-pump-inhibitor medication within 30 days of enrollment
  • 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 Design

Enrollment

34 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Interventions

CapScan collection capsule

The CapScan collection capsule is a single-use device that collects fluids from the gastrointestinal tract for analysis ex-vivo.

Primary outcome measure

  • Sampling of gut microbiota [ Time Frame: 56 days ]
  • Sampling of gut metabolome [ Time Frame: 56 days ]

Central Contacts and Locations

Central contacts

Jennifer Taufui

(650) 988-7530svgistaff@gmail.com

Locations

Silicon Valley Gastroenterology

Recruiting

Mountain View, California, United States, 94040

Contacts

Jennifer Taufui

svgistaff@gmail.com

More Information

Sponsor

Envivo Bio Inc

Last update posted

Jun 11, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Envivo Bio Inc on 2025-06-11.