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Trial · NCT06718686

Registered outcomes16

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

ListOutcomeTime frameDescription
PrimaryChange in stool and serum short-chain fatty acid levels10 weeksChange in SCFA in stool and serum in rifaximin SSD phase vs placebo phase
PrimaryChange in bile acids in stool and serum10 weeksChange in bile acids in stool and serum in rifaximin SSD phase vs placebo phase
SecondarySystemic inflammatory change10 weeksserum lipopolysaccharide-binding protein (LBP), inflammatory cytokines (IL-6, TNF-α, IL-10, IL-1β) in placebo phase vs Rifaximin SSD phase
SecondaryStool microbiome composition10 weeks16SrRNA microbiome composition and diversity change in placebo vs Rifaximin SSD phase
SecondaryChange in dementia biomarkers10 weeksPlasma concentrations of Aβ42 and Aβ40 to calculate amyloid-β (Aβ)42/40 ratio and plasma concentration of phospho-tau (p-tau)181 in placebo vs Rifaximin SSD phase
SecondaryMMSE10 weeksChange in MMSE between the 2 phases
SecondaryCognitive testing using Psychometric Hepatic Encephalopathy Score10 weeksChange in PHES in placebo vs rifaximin SSD phase
SecondaryClinical Dementia Rating - Sum of Boxes (CDR-SB)10 weeksChange in CDR-SB in placebo vs Rifaximin SSD phase
SecondaryEncephalApp Stroop performance10 weeksChange in off time and on time in seconds between placebo and rifaximin SSD phases
SecondaryCritical flicker fusion analysis10 weekschange in threshold to see CFF fusion in rifaximin SSD vs placebo phases
SecondaryKatz Index of Independence in Activity of Daily Living (ADL)10 weekschange in the score above judged by caregivers in placebo vs Rifaximin SSD phase
SecondaryLawton-Brody Instrumental Activities of Daily Living (IADL)10 weeksChange in instrument score above by caregivers in rifaximin SSD vs placebo phase
SecondaryZarit Burden Interview short form10 weeksChange in instrument score above by caregivers in rifaximin SSD vs placebo phase
SecondarySickness Impact profile10 weekschange in score of the QOL instrument above in placebo vs rifaximin SSD phases
SecondaryPROMIS-2910 weekschange in score of the QOL instrument above in placebo vs rifaximin SSD phases
SecondarySafety10 weeksSerious adverse event rates in placebo versus rifaximin SSD phases

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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