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Intestinal Failure clinical trials

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NCT ID: NCT06283615 Recruiting - Intestinal Failure Clinical Trials

Effect of Vitamin D on Skeletal Muscle Function and Qol in Patients With Chronic Intestinal Failure/Insufficiency

Start date: March 12, 2024
Phase: N/A
Study type: Interventional

Eligible patients were randomized into two groups: Vitamin D group and Control group. Control group: routine treatment only, no additional vitamin D intervention therapy. Vitamin D group: In addition to the conventional treatment, additional intramuscular injection of vitamin D2 was given once every two weeks, each dose of 600,000 units, and the treatment lasted for 12 weeks. The primary and secondary outcomes will be collected.

NCT ID: NCT06169774 Recruiting - Intestinal Failure Clinical Trials

Video Training Supplementation for Patients Discharged on Home Parental Nutrition

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to develop an educational video addressing the aseptic techniques to safely handle central catheters for administrating parenteral nutrition at home.

NCT ID: NCT05919680 Recruiting - Clinical trials for Intestinal Failure Associated Liver Disease

A Study of NST-6179 in Adult Subjects With Intestinal Failure-Associated Liver Disease (IFALD).

Start date: January 15, 2024
Phase: Phase 2
Study type: Interventional

This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NST-6179 in adult subjects with intestinal failure-associated liver disease (IFALD) receiving parenteral nutrition (PN). The study will be conducted in 2 sequential parts. Up to 36 adult subjects diagnosed with IFALD will be enrolled in the study, of which 18 subjects will be enrolled in each of the 2 parts and randomized (2:1) to receive NST-6179 (N=12/part) or matched placebo (N=6/part). Subjects in Part A will receive once daily (QD) oral administration of 800 mg (32 mL solution) NST-6179 or placebo for 4 weeks. The NST-6179 dose for Part B is planned to be 1200 mg QD for 12 weeks. Actual dose, however, will be determined during the safety review meeting.

NCT ID: NCT05902104 Recruiting - Hyperglycemia Clinical Trials

CGM-Assisted Management of PN

CAMP
Start date: July 6, 2023
Phase:
Study type: Observational

The purpose of this study is to learn more about changes in glucose levels in hospitalized infants with intestinal failure receiving parenteral nutrition or PN (nutrients delivered intravenously), as they transition from continuous PN (given 24 hours a day) to cycled PN (given less than 24 hours a day). There is an increased risk of glucose abnormalities with cycled PN, which can be harmful to infant growth and brain health. Continuous glucose monitors (CGM) will be used to measure interstitial glucose levels (in the tissue under the skin), which are similar to blood glucose levels. CGM is a small, minimally-invasive sensor worn on the thigh, which gives a glucose measurement every 5 minutes, and can help us understand changes in blood sugar levels without having to do a blood draw or fingerstick. CGM will be used during PN cycling for up to 30 days or until hospital discharge. If target GIR cycled PN is not reached following 3 sensor periods (up to 10 days per sensor), the parent/guardian will be approached to accept or decline participation in an optional extension phase. In the extension phase, the primary study will be repeated and CGM monitoring will continue until target GIR cycled PN is reached, up to an additional 3 sensor placements. CGM data will be hidden from the clinical team, there will be no change to routine clinical care. This study may help us understand how cycled PN affects glucose levels in infants with intestinal failure, which may help other children treated with cycled PN in the future.

NCT ID: NCT05868785 Recruiting - Osteoporosis Clinical Trials

Effect of Nocturnal Parenteral Nutrition on Bone Turnover and Energy Metabolism

NutriSync
Start date: July 13, 2023
Phase: N/A
Study type: Interventional

This clinical trial will study the effect of daytime versus nighttime parenteral nutrition on bone turnover, glucose variability, nitrogen balance, sleep and wake rhythm and peripheral clock gene expression in patients with chronic intestinal failure.

NCT ID: NCT05813535 Recruiting - Intestinal Failure Clinical Trials

8.4% Sodium Bicarbonate Locks in Intestinal Failure

Start date: December 1, 2022
Phase: Phase 2
Study type: Interventional

We plan to include children with intestinal failure, a condition where the gut is not functioning properly, leading these children to need central venous catheters (line that goes through the skin into the blood stream) for nutritional support and hydration. Such patients have a very high risk for catheter infection. The study will include placing an agent (sodium bicarbonate) into the central catheter when the catheter is not in use. This is referred to as a lock. The lock would be used daily and removed when patients start their nutritional support and hydration through the catheter.

NCT ID: NCT05315765 Recruiting - Ileus Clinical Trials

Development of a Patient Reported Outcome Measure for GastroIntestinal Recovery

PRO-diGI
Start date: October 28, 2021
Phase:
Study type: Observational

People who undergo surgery, or develop intestinal obstruction will spend a period of time without normal bowel function. This might extend beyond the normal measures of passage of flatus or tolerance of diet. This study will take a three stage approach to develop a patient reported outcome measure for gastrointestinal recovery. Stage 1: Qualitative interviews with 20-40 patients who have undergone major abdominal surgery, or conservatively managed intestinal obstruction. These interviews will identify key themes and ideas to develop the questionnaire. Stage 2: Face validity testing of questionnaire with 20 patients, using the QQ-10 questionnaire to aid assessment. The questionnaire may be edited after this. Stage 3: 250-500 patients will be asked to complete the questionnaire following surgery or treatment for intestinal obstruction. Basic demographics will also be collated. Item reduction and scale refinement will be undertaken using this dataset. This will provide a PROM of gastrointestinal recovery which is ready for validation.

NCT ID: NCT04733066 Recruiting - Clinical trials for Short Bowel Syndrome

Quality of Life in Patients With Short Bowel Syndrome Treated Without and With Teduglutide - a Prospective Nested Matched Pair Analysis

MatchedQoL
Start date: September 1, 2020
Phase:
Study type: Observational

The aim of this prospective longitudinal study is to compare the quality of life of short bowel patients prior to and on teduglutide treatment with a non-treated patient group in a matched-pair design.

NCT ID: NCT04629014 Recruiting - Clinical trials for Pediatric Intestinal Failure

Prospective Multisite Study of Quality of Life in Pediatric Intestinal Failure

Start date: February 27, 2020
Phase:
Study type: Observational

This study proposes to quantify and describe the quality of life of children with intestinal failure, and to identify the medical and socio-economic factors that impact this quality of life, using data from multiple multidisciplinary intestinal failure centers across the United States and Canada specializing in the care of these participants.

NCT ID: NCT04604275 Recruiting - Short Gut Syndrome Clinical Trials

Functional Sucrase Deficiency in Short Bowel Syndrome Patients With Intestinal Failure

Start date: February 2, 2022
Phase: Phase 2
Study type: Interventional

Short gut syndrome with intestinal failure patients may have decreased production of disaccharidases, like sucrase, an enzyme responsible for digesting sugar in foods. This can happen due to loss of bowel length from surgery or from loss of cellular function in the intestines due to use of parenteral nutrition intravenously. Therefore, patients with these conditions may not be able to digest sucrose (sugar) fully. Patients might experience abdominal distension/pain, vomiting and diarrhea when sugar is taken in orally or through the g-tube, which can limit patients' ability to increase oral or g-tube feeds in short gut syndrome patients with intestinal failure. In patients with short gut syndrome and intestinal failure, the administration of exogenous sucrase (enzyme) may improve sucrose (sugar) digestion and thus the ability to tolerate more oral or g-tube feeds.