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Trial · NCT07882953

SIMBA in Irritable Bowel Syndrome (IBS)

NCT07882953, Phase 1, Not yet recruiting, University of Calgary

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. SIMBA in Irritable Bowel Syndrome (IBS). Trials, record NCT07882953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07882953

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
SIMBA in Irritable Bowel Syndrome (IBS)
NCT number
NCT07882953
Status
Not yet recruiting
Phases
Phase 1
Enrollment
180 participants, estimated
Lead sponsor
University of Calgary
Conditions
Irritable Bowel Syndrome (IBS), Microbiome
Interventions
Rifaximin (drug), fluid biopsy capsule
First posted
2026-10-20
Last updated
2026-10-20

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in small intestinal microbiome compositionBaseline and 4 weeks post end of treatmentDifference in small intestinal microbiome composition (Community Distance Index) within participant
SecondaryChange in Abdominal Pain Severity (VAS-IBS)Baseline and 4 weeks post end of treatmentChange in participant's abdominal pain sub-score measured using the Visual Analogue Scale for Irritable Bowel Syndrome (VAS-IBS)
SecondaryDifference in Dominant Microbial Composition Index Among IBS Rome V SubtypesBaseline and 4 weeks post end of treatment
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.
SecondaryChange in Antimicrobial Resistance Gene Burden and Microbial Antimicrobial ResistanceBaseline and 4 weeks post end of treatment
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.
SecondaryPredictive Accuracy of Baseline Multi-Omic Features for Clinical Response to RifaximinBaseline and 4 weeks post end of treatment
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.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07882953

GET https://conductscience.org/api/trials/v1/NCT07882953/registered