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Intestinal Failure clinical trials

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NCT ID: NCT06391762 Completed - Clinical trials for Short Bowel Syndrome

Level of Deprivation Assessment in a Population of Short-bowel Syndrome Patients With Intestinal Failure

PRECAR-SGC
Start date: December 28, 2023
Phase:
Study type: Observational

The association between social deprivation and chronic disease is regularly examined but there are no data available on patients with intestinal failure due to short bowel syndrome (SBS-IF). First, the investigators aim to characterize this population and then to assess if insecurity is associated with some disease criteria.

NCT ID: NCT05909228 Completed - Osteoporosis Clinical Trials

Bone Markers in Pediatric IF

Start date: March 31, 2023
Phase:
Study type: Observational

Poor bone health is a well-recognized but poorly understood complication in children with intestinal failure (IF) who are dependent on parenteral nutrition (PN). Previously, we showed that children with IF have decreased bone turnover markers. It is currently unknown if optimization of parenteral nutrition is related to improved bone turnover markers. Serum concentrations of bone markers (osteocalcin, bone-specific alkaline phosphatase and c-telopeptide) will be measured in 30 IF patients treated at a multidisciplinary intestinal rehabilitation and home PN program at the Hospital for Sick Children and compared to bone markers in 30 age- and sex-matched healthy controls.

NCT ID: NCT05857254 Completed - Clinical trials for Chronic Intestinal Failure

Treatment Adherence of Home Parenteral Nutrition in Patients With Chronic Intestinal Failure. (QANPIC)

Start date: June 29, 2023
Phase:
Study type: Observational

This observational, cross-sectionnal, multicentric study evaluates treatment adherence of home parenteral nutrition in patients with chronic intestinal failure.

NCT ID: NCT05011370 Completed - Clinical trials for Intestinal Failure-associated Liver Disease

Prevalence of Liver Disease in Patients Dependent on Parenteral Nutrition

THRIVE-1
Start date: August 23, 2021
Phase:
Study type: Observational

This is a multi-center prospective cross-sectional observational study that will assess the prevalence of liver disease in patients dependent on parenteral nutrition (PN) for 4 or more days per week. Liver disease will be determined by the presence of choline deficiency, cholestasis (confirmed by elevated serum alkaline phosphatase (ALP) liver isoenzyme level), and steatosis (confirmed by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF). The objective of this study is to investigate the presence/prevalence of liver disease in patients dependent on PN (≥4 days a week).

NCT ID: NCT04981262 Completed - Clinical trials for Short Bowel Syndrome

Improved Quality of Life in Children With Intestinal Failure

Start date: September 2, 2021
Phase: N/A
Study type: Interventional

Children with intestinal failure have a lack of tolerance for food in the intestine. The children are dependent on intravenous nutrition over a long period of time period to ensure growth and development. The condition is characterized by bacterial overgrowth in the intestine, with nausea, vomiting, diarrhea and flatulence as physical symptoms. Mental health is affected in the form of lower quality of life, lack of school participation and less social contact with peers. The investigators own (unpublished) data show that children with intestinal failure have a lower quality of life than healthy people. Standard treatment is antibiotics, but the effect of these is short-lived, and many must have repeated courses. Prebiotics are indigestible carbohydrates (fiber) in foods that positively affect the bacterial flora and promote intestinal health. In this project the investigators want to see if supply of prebiotics can change the bacterial balance, reduce symptoms of bacterial overgrowth and increase quality of life. The study is unique, as Prebiotics have not previously been used in the treatment of intestinal failure. If successful, it can pave the way for a new and better treatment method that can potentially be transferred to other conditions with imbalance in the intestinal flora. The study is a randomized intervention study and is consist of two phases. In phase 1, the effect of 4 weeks of open intervention with prebiotics is studied to establish so-called "proof of concept". Data from phase 1 are used to look at connections between the composition of intestinal flora, nutritional status and bowel function. The intervention involves the use of a prebiotic product (Stimulance, Nutricia), which is added to childs regular food. In phase 2, patients are randomized into two groups. One group will continue with the product for 6 months, while the other group does not receive prebiotics.

NCT ID: NCT04964986 Completed - Clinical trials for Short Bowel Syndrome

Metabolic Balance Study of Apraglutide in Patients With SBS-IF and Colon-in-Continuity

STARSnutrition
Start date: June 14, 2021
Phase: Phase 2
Study type: Interventional

The primary objective of the trial is to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC.

NCT ID: NCT04627025 Completed - Clinical trials for Short Bowel Syndrome

Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF

STARS
Start date: January 26, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.

NCT ID: NCT03869957 Completed - Intestinal Failure Clinical Trials

Effect of Parenteral Nutrition With n-3 PUFAs on Patients With Intestinal Failure

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

Randomized, double-blind, controlled clinical trial to evaluate the effect of parenteral nutrition (PN) supplemented with lipid emulsions containing 0.1-0.2 g omega 3 polyunsaturated fatty acids (n-3 PUFA)/kg body weight/day for 7 days on malondialdehyde (MDA) levels, a marker of lipoperoxidation of reactive species, compared with a control group (without n-3 PUFA) in patients with intestinal failure (IF).

NCT ID: NCT03222232 Completed - Intestinal Failure Clinical Trials

Catheter Salvage in Intestinal Failure Patients

Start date: January 1, 2002
Phase: N/A
Study type: Observational

This is an observational study evaluating a catheter salvage strategy in relation to catheter-related bloodstream infections in patients with chronic intestinal failure dependent on home parenteral support. The study is confined to the period 2002 to 2016.

NCT ID: NCT01986153 Completed - Intestinal Failure Clinical Trials

Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients

Start date: December 2013
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to determine if patients on long-term olive oil-based parenteral nutrition have an adequate essential fatty acid status and immune status, compared to age- and sex-matched healthy controls.