Health TrialsbyHealthPanel

Evaluating the Effect Of Rifaximin on the Gut Microbiota and Metabolome in SIBO Using CapScan®

ConditionSmall Intestinal Bacterial Overgrowth
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEnvivo Bio Inc

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • CapScan collection capsule

    Device

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Sampling of gut microbiota

\> 75% of the retrieved CapScan devices to provide at least 3 million metagenomic DNA sequencing reads of gut microbes from the intestinal tract, and at least 900 annotated gut metabolites.

Time frame
56 days
2

Sampling of gut metabolome

\>75% of the retrieved CapScan devices to provide at least 900 annotated gut metabolites.

Time frame
56 days

Secondary outcomes

1

Effect of rifaximin on gut microbiota

Determine the effect of rifaximin on the regional compositions of the gut microbiota among SIBO patients by assessing the diversity, centroids and distributions of microbial taxa from sequenced CapScan samples of each subject before and after rifaximin at 5 time points.

Time frame
56 days
2

Effect of rifaximin on gut metabolome

Determine the effect of rifaximin on the regional compositions of the gut metabolites among SIBO patients by assessing the changes to metabolite classes and metabolic pathways as measured by LC/MS-MS analysis of CapScan samples for each subject before and after rifaximin at 5 time points.

Time frame
56 days

Other outcomes

Sponsors and contacts

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Envivo Bio Inc

Lead sponsor

Source ClinicalTrials.gov
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