A Phase 1 interventional study of Rifaximin (drug) and fluid biopsy capsule in Irritable Bowel Syndrome (IBS) and Microbiome, sponsored by University of Calgary. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by University of Calgary · Phase 1, Interventional, and Basic science
This study is intended to characterize longitudinal changes in the small intestinal microbiome following rifaximin treatment in participants with Irritable Bowel Syndrome (IBS) over a 12 week period.
The goal of this open-label interventional trial is to evaluate the changes in the small intestinal microbiome in a population of 180 adults with irritable bowel syndrome (IBS) over a twelve week period. The study will compare microbiome data collected with the SIMBA capsule before, during and after treatment, along with qualitative questionnaires.
1,084 studies on the registry are indexed under Irritable Bowel Syndrome; 196 are open to participants now.
This study's planned enrollment of 180 is above the median of 70 across 869 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →University of Calgary is the lead sponsor of 699 studies on the registry; 192 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
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Exclusion Criteria:
Any significant medical condition that, in the opinion of the Principal Investigator or Qualified Investigator, could interfere with study participation, intervention, or outcome assessment, including:
Concomitant Supplements Participants taking supplements that are judged by the investigators not to interfere with study outcomes (e.g., vitamins, omega-3 fatty acids, creatine monohydrate) may continue use, provided the dose remains unchanged throughout the study, are not taken within 6 hours on either side of capsule ingestion, and no new supplements are introduced unless medically recommended.
Pregnancy Assessment Females of childbearing potential will be assessed for pregnancy risk through self-report. A urine β-hCG test will be required if pregnancy status is uncertain. Participants who become pregnant during the study will discontinue the study medication immediately and notify the investigators.
As confirmed by diagnosis and/or Principal Investigator assessment and measured via patient response to validated questionnaires
Drug: Rifaximin (drug) · Device: fluid biopsy capsule
As confirmed by diagnosis and/or Principal Investigator assessment and measured via patient response to validated questionnaires
Drug: Rifaximin (drug) · Device: fluid biopsy capsule
As confirmed by diagnosis and/or Principal Investigator assessment and measured via patient response to validated questionnaires
Drug: Rifaximin (drug) · Device: fluid biopsy capsule
Open label
Collection of a fluid biopsy from the small intestine via ingestible capsule
Change in small intestinal microbiome composition
Difference in small intestinal microbiome composition (Community Distance Index) within participant
Time frame: Baseline and 4 weeks post end of treatment
Change in Abdominal Pain Severity (VAS-IBS)
Change in participant's abdominal pain sub-score measured using the Visual Analogue Scale for Irritable Bowel Syndrome (VAS-IBS)
Time frame: Baseline and 4 weeks post end of treatment
Difference in Dominant Microbial Composition Index Among IBS Rome V Subtypes
Dominant microbial composition index will be developed using shotgun metagenomic sequencing and metabolome analysis of capsule samples for each IBS sub-type (D, C and M) by collating sample results for participants by study arm. This microbial composition index for each arm will be described and differences compared.
Time frame: Baseline and 4 weeks post end of treatment
Change in Antimicrobial Resistance Gene Burden and Microbial Antimicrobial Resistance
Characterize intrinsic antimicrobial resistance (AMR) profiles of microbial species and subspecies identified in small intestinal samples via shotgun sequencing, measured through copy numbers of NCBI AMRFinder+ genome annotations.
Time frame: Baseline and 4 weeks post end of treatment
Predictive Accuracy of Baseline Multi-Omic Features for Clinical Response to Rifaximin
Microbiome feature selection and documentation (p-Values, effect size) based on Linear Mixed Effect modelling of clinical response. Model performance metrics (e.g., discrimination, calibration, and predictive accuracy) for predicting clinical response to rifaximin using baseline clinical characteristics and small intestinal multi-omic features measured via shotgun sequencing and metabolomic analysis.
Time frame: Baseline and 4 weeks post end of treatment
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rifaximin