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Not yet recruitingNCT07882953SIMPACTUpdated Oct 20, 2026

SIMBA in Irritable Bowel Syndrome (IBS)

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

Updated Oct 20, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
180
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Irritable Bowel Syndrome (IBS)
  • Microbiome
03

In context

Irritable Bowel Syndrome

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18-65 years at the inclusion of the study, both female and male subjects.
  2. Provide informed consent to participate in study; willing and able to comply with study procedures.
  3. Able to swallow a capsule sized 25mm length and 9mm width (i.e. large dose omega 3 pill).
  4. Willing to maintain their diet and physical activity levels during the study.
  5. Participants with a confirmed or suspected diagnosis of Irritable Bowel Syndrome (IBS) meeting or presenting with symptoms consistent with Rome V criteria for one of the following subtypes: IBS-C, IBS-M, or IBS-D.
  6. Baseline weekly average of worst daily (in past 24 hours) abdominal bloating score of >= 3.0 on a 0-to-10-point scale.

Exclusion criteria

Exclusion Criteria:

  1. Non-English speaking.
  2. Regular use of probiotics, prebiotics or synbiotics (including food and drinks containing added probiotics and/or probiotic yogurts with live, active cultures, or kefir) within 1 month prior to screening. Non-probiotic fortified yogurt is acceptable. Potential participants may be eligible once a 1-month washout is completed.
  3. Stimulant laxative use (includes bisacodyl/Dulcolax, senna/Senekot, cascara, or fiber supplements) is allowed if it is kept unchanged in the week prior to the SIMBA capsule ingestion. Osmotic laxatives (polyethylene glycol (PEG; other trade names), milk of magnesia, lactulose), stool softeners (docusate; other trade names) or secretagogues (linaclotide/Constella, plecanatide/Trulance, tenapanor/Ibsrela should not be used within 7 days of taking the SIMBA capsules.
  4. Use of oral or intravenous antibiotics or antifungal medications (except topical antibiotics or antifungals) within the previous 12 weeks. This includes rifaximin.
  5. Use of medications known to affect gastrointestinal motility, including but not limited to prokinetics (including domperidone, metoclopramide, prucalopride), anticholinergics, opioids, GLP-1 receptor agonists, secretagogues (linaclotide, plecanatide, tenapenor), cholestyramine, colchicine, and methyldopa, unless permitted by protocol.
  6. Chronic use of salicylates, aspirin (ASA), corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), misoprostol or other medications known to affect small intestinal mucosal integrity, as determined by the Principal Investigator.
  7. Current smoker or use of tobacco, nicotine, or cannabis products including vapes, gums, gummies, or other ingestible or inhaled formats.
  8. Alcohol consumption >21 units per week, alcohol abuse, or illicit drug use.
  9. Currently dieting for weight loss or following a low-carbohydrate diet.
  10. Participation in another clinical trial within 30 days prior to enrollment.
  11. Known allergy or hypersensitivity to rifaximin.
  12. Pregnancy, lactation, planned pregnancy during the study period, or unwillingness to use an approved method of contraception if of childbearing potential.
  13. Major surgery within the previous 3 months.
  14. 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:

    • Renal disease
    • Gastrointestinal disorders (includes inflammatory bowel disease, celiac disease (treated or untreated), any eosinophilic gastrointestinal disorder, microscopic colitis)
    • Autoimmune disease (including Rheumatoid arthritis, lupus, scleroderma)
    • Metabolic disease (type 1 diabetes is excluded. Controlled Type 2 diabetes may be acceptable per investigator's discretion)
    • Cardiovascular or vascular disease
    • Respiratory disease (COPD, home oxygen use is excluded. Mild asthma (prn puffer use) may be acceptable)
    • major mental health disorder
    • Hyperthyroidism (whether controlled or not). Controlled hypothyroidism is allowable
  15. Prior fecal microbiota transplantation, less than a year before study enrollment.
  16. Cancer diagnosis or treatment within the past year (except non-melanoma skin cancer).

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.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Active comparator
    Irritable Bowel Syndrome - Diarrhea

    As confirmed by diagnosis and/or Principal Investigator assessment and measured via patient response to validated questionnaires

    Drug: Rifaximin (drug) · Device: fluid biopsy capsule

  • Active comparator
    Irritable Bowel Syndrome - Constipation

    As confirmed by diagnosis and/or Principal Investigator assessment and measured via patient response to validated questionnaires

    Drug: Rifaximin (drug) · Device: fluid biopsy capsule

  • Active comparator
    Irritable Bowel Syndrome - Mixed

    As confirmed by diagnosis and/or Principal Investigator assessment and measured via patient response to validated questionnaires

    Drug: Rifaximin (drug) · Device: fluid biopsy capsule

Interventions

  • Open label

  • Devicefluid biopsy capsule

    Collection of a fluid biopsy from the small intestine via ingestible capsule

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

07

Study locations

1 site
  • University of Calgary, Foothills Campus
    Calgary, Alberta T2N 4Z6, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

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.

Registered
Oct 6, 2026
First posted
Oct 20, 2026
StartEst.
Nov 2026
Primary completionEst.
Dec 2027
CompletionEst.
Sep 2028
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07882953
Collaborators
Nimble Science Ltd., Genome Alberta
Responsible party
Sponsor
First posted
Oct 20, 2026
Start date
Nov 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Sep 2028 (estimated)
Last update
Oct 20, 2026

Study contacts

Lynn Wilsack, MSc
Contact
lwilsack@ucalgary.ca
403 592-5045
Christopher N Andrews, MD MSc
principal investigator · University of Calgary

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Rifaximin

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