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Trial · NCT03716115

Registered outcomes21

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

ListOutcomeTime frameDescription
PrimaryComposite measure of concentration of three faecal inflammatory markers14-18 daysComposite measure of concentration of three faecal inflammatory markers (myeloperoxidase, neopterin, alpha1-antitrypsin) measured by ELISA
SecondaryLactulose:rhamnose ratio14-18 daysLactulose:rhamnose ratio of concentration in urine samples collected over 2 hours following oral administration of test dose
SecondaryPlasma lipopolysaccharide (LPS)14-18 daysPlasma LPS concentration measured by limulus amoebacyte lysate assay
SecondaryPlasma biomarker lipopolysaccharide binding protein (LBP)14-18 daysPlasma LBP concentration measured by ELISA
SecondaryPlasma fatty acid binding protein (FABP)14-18 daysPlasma FABP concentration measured by ELISA
SecondaryPlasma soluble CD1414-18 daysPlasma concentration of soluble CD14 measured by ELISA
SecondaryPlasma CD16314-18 daysPlasma concentration of CD163 measured by ELISA
SecondaryPlasma CRP14-18 daysPlasma concentration of C-reactive protein measured by ELISA
SecondaryPlasma albumin14-18 daysPlasma concentration of albumin measured by ELISA
SecondaryMortality14 days and 28 daysNumber of deaths in each treatment allocation group
SecondaryAdverse events14 days and 28 daysNumber of adverse events in each treatment allocation group
SecondaryChange in weight and length14 days and 28 daysChange in weight and length measured by experienced nurses and expressed as change in weight-for-length z score compared to WHO standard
SecondaryDays with diarrhoea14-18 daysNumber of days during which diarrhoea was experienced assessed by experienced nurses
SecondaryDays with fever14-18 daysxv. Days with fever (two or more recordings of core temperature of 37.8oC or higher in any 24 h period)
SecondaryVillus height: crypt depth ratio14-18 daysChange in villus height and crypt depth measured in endoscopic biopsies (Lusaka only)
SecondaryEpithelial leakiness14-18 daysLeakage of fluorescein into gut lumen assessed by Watson score during confocal laser endomicroscopy (Lusaka only)
SecondaryTertiary Objectives-Tertiary Endpoints- Exploratory work on glyscosylation14-18 daysGlycosylation in saliva and biopsies
OtherMetabolomics14-18 daysUntargeted metabolomic profile by mass spectroscopy, and specific measurement of citrulline, tryptophan and kynurenine
OtherTranscriptomic analysis14-18 daysUntargeted analysis of mRNA sequencing data from intestinal biopsies
OtherConfocal laser endomicroscopy14-18 daysMucosal leakiness measured by observation of plumes and luminal fluorescein during confocal laser endomicroscopy

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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