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Trial · NCT04991311

Registered outcomes27

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

ListOutcomeTime frameDescription
PrimaryChange in Absorption of Wet Weight/Fluidsfrom Week 0 (baseline) to Week 24
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
SecondaryChange in Absorption of Energyfrom Week 0 (baseline) to Week 24
Oral intake minus fecal excretion: measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. Energy absorption was measured by bomb calorimetry.
SecondaryChange in Absorption of Carbohydratesfrom Week 0 (baseline) to Week 24
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
SecondaryChange in Absorption of Lipidsfrom Week 0 (baseline) to Week 24
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
SecondaryChange in Absorption of Proteinsfrom Week 0 (baseline) to Week 24
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
SecondaryChange in Absorption of Sodiumfrom Week 0 (baseline) to Week 24
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
SecondaryChange in Absorption of Potassiumfrom Week 0 (baseline) to Week 24
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
SecondaryChange in Absorption of Calciumfrom Week 0 (baseline) to Week 24
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
SecondaryChange in Absorption of Magnesiumfrom Week 0 (baseline) to Week 24
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
SecondaryChange in Weekly Parenteral Support (PS) Volumefrom Week 0 (baseline) to Week 12Only for participants with Short Bowel Syndrome with Intestinal Failure (SBS-IF). PS use was recorded in patient diaries throughout the trial, including type and volume used.
SecondaryChange in Weekly PS Volumefrom Week 0 (baseline) to Week 24Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
SecondaryChange in Weekly PS Carbohydratesfrom Week 0 (baseline) to Week 12Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
SecondaryChange in Weekly PS Carbohydratesfrom Week 0 (baseline) to Week 24Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
SecondaryChange in Weekly PS Lipidsfrom Week 0 (baseline) to Week 12Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
SecondaryChange in Weekly PS Lipidsfrom Week 0 (baseline) to Week 24Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
SecondaryChange in Weekly PS Proteinsfrom Week 0 (baseline) to Week 12Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
SecondaryChange in Weekly PS Proteinsfrom Week 0 (baseline) to Week 24Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
SecondaryChange in Weekly PS Sodiumfrom Week 0 (baseline) to Week 12Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
SecondaryChange in Weekly PS Sodiumfrom Week 0 (baseline) to Week 24Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
SecondaryChange in Weekly PS Potassiumfrom Week 0 (baseline) to Week 12Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.

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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