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Trial · NCT04480554

Registered outcomes25

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

ListOutcomeTime frameDescription
PrimaryChange in sCD14Baseline, Week-4, -8, -12, -24Change in plasma sCD14 concentration over 24 weeks
SecondaryMarker of Immune Activation: Change in CD38baseline, Week-4, -8, -12, -24Change in CD38 concentration over 24 weeks
SecondaryMarker of Immune Activation: HLA-DRbaseline, Week-4, -8, -12, -24Change in HLA-DR concentration over 24 weeks
SecondaryMarker of Immune Activation: Change in PD1baseline, Week-4, -8, -12, -24Change in PD1 expression in C8+ T cells over 24 weeks
SecondaryMarker of Immune Activation: Change in CD169baseline, Week-4, -8, -12, -24Change in CD169 expression in monocytes over 24 weeks
SecondaryMarker of Immune Activation: Change in sCD163baseline, Week-4, -8, -12, -24Change in plasma sCD163 concentration over 24 weeks
SecondaryMarker of Immune Activation: Change in Type-I IFNbaseline, week -12, -24Change in type-I IFN signature over 24 weeks
SecondaryMarker of Inflammation: Change in Plasma Hr-CRPbaseline, Week-4, -8, -12, -24Change in plasma hr-CRP concentration over 24 weeks
SecondaryMarker of Inflammation: Change in D-dimerbaseline, Week-4, -8, -12, -24Change in plasma d-dimer concentration over 24 weeks
SecondaryMarker of Inflammation: Change in sTNFR-1baseline, Week-4, -8, -12, -24Change in plasma sTNFR-1 concentration over 24 weeks
SecondaryMarker of Inflammation: Change in Interleukins IL-6 and IL-10baseline, Week-4, -8, -12, -24Change in plasma IL-6 and IL-10 concentration over 24 weeks
SecondaryMarker of Inflammation: Change in TGF-betabaseline, Week-4, -8, -12, -24Change in plasma TGF-beta concentration over 24 weeks
SecondaryMarker of Bacterial Translocation: Change in LPBBaseline, Week-24Change in plasma LPB concentration at 24 weeks
SecondaryMarker of Bacterial Translocation: Change in LPSBaseline, Week-24Change in plasma LPS concentration at 24 weeks
SecondaryMarker of Bacterial Translocation: Change in Endo-CABBaseline, Week-24Change in plasma endo-CAB concentration at 24 weeks
SecondaryMarker of Bacterial Translocation: Change in Intestinal Fatty Acid-binding Protein (I-FABP)Baseline, Week-24Change in plasma I-FABP concentration at 24 weeks
SecondaryMarker of Bacterial Translocation: Change in Zonulin-1Baseline, Week-24Change in plasma Zonulin-1 concentration at 24 weeks
SecondaryMarker of Bacterial Translocation: Change in s16 rDNABaseline, Week-24Change in s16rDNA concentration at 24 weeks
SecondaryMarker of Bacterial Translocation: Change in Bacterial Butyryl-coA-coABaseline, Week-24Change in bacterial butyryl-coA-coA concentration at 24 weeks
SecondaryRetention in CareBaseline to Week-24Number of participants who were receiving treatment ar Week 4, 8, 12, 16, 20 and 24

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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