Clinical trials: Intestinal Failure
Short Bowel Syndrome
Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC)
The primary objective of the trial is to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC.
- Trial name
- STARSnutrition (NCT04964986)
- Testing
- Apraglutide
- Where
- 2 sites in Belgium, France
- Volunteers
- 10 people
- Sponsor
- VectivBio AG
Renal Failure Chronic
Probiotics and Low Protein Diet in Advanced Chronic Kidney Disease
Here the investigators will perform a double-blinded randomized placebo-controlled clinical trial to evaluate the synergic effect of low protein diet and prebiotics in reducing the microbial inflammatory uremic toxins.
- Trial name
- ProLowCKD (NCT04204005)
- Testing
- Probiotics
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Probiotical S.p.A.
Colorectal Neoplasms
A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen
The study is designed to demonstrate that the combination of AG-013736 with either FOLFIRI or FOLFOX is superior to FOLFIRI or FOLFOX in combination with bevacizumab (Avastin) in delaying tumor progression in the second-line…
- Trial name
- NCT00615056
- Testing
- Bevacizumab (avastin), FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU]), AG-013736 (axitinib)
- Where
- 83 sites in United States, Canada and 6 more
- Volunteers
- 171 people
- Sponsor
- Pfizer
Short Bowel Syndrome
Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF
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.
- Trial name
- STARS (NCT04627025)
- Testing
- apraglutide
- Where
- 68 sites in United States, Argentina and 16 more
- Volunteers
- 164 people
- Sponsor
- VectivBio AG
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD).
- Trial name
- NCT02476994
- Testing
- Clinolipid, Intralipid
- Where
- 4 sites in United States
- Volunteers
- 1 people
- Sponsor
- Baxter Healthcare Corporation
Metabolic Disorder; Carbohydrate, Absorption, Intestine
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content Consumed Alone.
This study aimed at determining the 4-hours postprandial blood glucose and insulin responses to the ingestion of cereal product differing by their SDS content.
- Trial name
- NCT02538653
- Testing
- Sandwich biscuit high in SDS, Co-extruded cereal low in SDS
- Where
- Australia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Mondelēz International, Inc.
Fecal Incontinence
Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.
- Trial name
- TRANSFORM (NCT01090739)
- Testing
- TOPAS Treatment for Fecal Incontinence
- Where
- 14 sites in United States
- Volunteers
- 207 people
- Sponsor
- ASTORA Women's Health
Colorectal Neoplasms
Asian Subjects With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy
The purpose of this study is to assess if Regorafenib in combination with best supportive care will slow down tumor progression and result in increased survival in patients with metastatic colorectal cancer.
- Trial name
- CONCUR (NCT01584830)
- Testing
- Regorafenib (BAY73-4506)
- Where
- 25 sites in China, Hong Kong and 3 more
- Volunteers
- 204 people
- Sponsor
- Bayer
Advanced Solid Tumors or Non-Hodgkin's Lymphoma (NHL)
A Phase 1/2 Trial of SRA737 in Subjects With Advanced Cancer
The purpose of this clinical study is to establish the safety profile, determine the maximum tolerated dose (MTD) and recommend a Phase 2 dose and schedule of SRA737; and to evaluate the efficacy of SRA737 in…
- Trial name
- NCT02797964
- Testing
- SRA737
- Where
- 15 sites in United Kingdom
- Volunteers
- 107 people
- Sponsor
- Sierra Oncology LLC - a GSK company
Short Bowel Syndrome
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
The purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and generate additional long-term safety data.
- Trial name
- EASE SBS 5 (NCT07197944)
- Testing
- Glepaglutide
- Where
- 33 sites in United States, Austria and 12 more
- Volunteers
- 90 people
- Sponsor
- Zealand Pharma
Intestinal Failure
AI-driven Total Parenteral Nutrition Platform
This study tests whether an artificial intelligence (AI) tool can help doctors order total parenteral nutrition (TPN) for babies in the neonatal intensive care unit (NICU).
- Trial name
- NCT07414576
- Testing
- AI-driven total parenteral nutrition (TPN)
- Where
- United States
- Volunteers
- 260 people
- Sponsor
- Takeoff41, Inc.
Chronic Kidney Failure
Observational Study of Kibow Biotics in Dialysis Patients
A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "Enteric DialysisTM".
- Trial name
- NCT01450670
- Testing
- Kibow Biotics
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Kibow Pharma
Colorectal Carcinoma
A Phase II Study of Cetuximab Plus Irinotecan in Patients With EGFR-detectable Metastatic Colorectal Carcinoma
To evaluate the response rate of cetuximab plus irinotecan combination therapy in subjects with EGFR-detectable metastatic colorectal carcinoma who have documented progressive disease to irinotecan-based chemotherapy and who have…
- Trial name
- NCT00362102
- Testing
- Cetuximab
- Volunteers
- 38 people
- Sponsor
- Eli Lilly and Company
Metastatic Colorectal Cancer
Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy
This is a randomized, double-blind, placebo-controlled multi-center phase III study to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed on/after all approved…
- Trial name
- NCT01103323
- Testing
- Regorafenib (Stivarga, BAY73-4506), Best Supportive Care (BSC)
- Where
- 171 sites in United States, Argentina and 17 more
- Volunteers
- 760 people
- Sponsor
- Bayer
Short Bowel Syndrome
Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects
This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912(sonefpeglutide) in adult subjects with SBS-associated intestinal…
- Trial name
- NCT04775706
- Testing
- HM15912 Active
- Where
- 15 sites in United States, Belgium and 6 more
- Volunteers
- 18 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Chronic Kidney Failure
Pilot-Scale Clinical Trials of Kibow Biotics® in Chronic Kidney Failure
The bowel can serve as a complement to the kidneys' excretory function A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been called "enteric…
- Trial name
- Probiotics (NCT00760162)
- Where
- 2 sites in United States
- Volunteers
- 180 people
- Sponsor
- Kibow Pharma
Chronic Kidney Disease
Observational Study of Kibow Biotics in Chronic Kidney Failure Patients on Dialysis
A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "Enteric DialysisTM".
- Trial name
- NCT01450709
- Testing
- Kibow Biotics
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Kibow Pharma
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care (Intralipid) from 7 up to 90 days to develop Essential Fatty Acid…
- Trial name
- NCT04555044
- Testing
- Clinolipid, Intralipid
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Baxter Healthcare Corporation
Colorectal Carcinoma, CRC
Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma
The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in colorectal carcinoma patients who are refractory to…
- Trial name
- NCT01394939
- Testing
- JX-594, Irinotecan
- Where
- 11 sites in United States, Canada and 1 more
- Volunteers
- 52 people
- Sponsor
- Jennerex Biotherapeutics
Colorectal Neoplasms, Neoplasm Metastasis
Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen
The main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan…
- Trial name
- VELOUR (NCT00561470)
- Testing
- Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®), FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
- Where
- 221 sites in United States, Argentina and 26 more
- Volunteers
- 1,226 people
- Sponsor
- Sanofi