Clinical trials: Gastrointestinal Dysfunction
Autism Spectrum Disorder, Autism
Autism Spectrum Disorder (ASD) Neurodevelopmental Disorder With Issues Social Behavior, Communication Issues, GI Dysfunction. Study is Multimodal Interventions Targeting These Pathways With cSVF, Stored MSCs, FMT and Diet Modification. Role of Autoimmunity, Gut-brain Issues, & Issues Examined.
Autism spectrum disorder (ASD) is a neurodevelopmental condition with core deficits in social communication and behavior, often accompanied by gastrointestinal (GI) and metabolic dysfunction.
- Conditions
- Autism Spectrum Disorder, Autism, Autism Spectral Disorder
- Trial name
- GARM-Autism (NCT07546942)
- Testing
- Autologous MSC isolation, concentration, and cryopreservation of adult mesenchymal stem cells, Fecal Biomicrome Transplantation (FMT), Ketogenic RESET Diet Protocol
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Black Tie Medical, Inc.
Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-alcoholic Fatty Liver Disease
Alternate Dosing Study of MK-6024 in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (MK-6024-016)
This study will evaluate the effect of efinopegdutide administration once every 2 weeks (Q2W) versus once weekly (Q1W) on mean relative reduction from baseline in liver fat content (LFC) after 28 weeks, as well as the safety and…
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-alcoholic Fatty Liver Disease, Nonalcoholic Fatty Liver Disease, Liver Disease
- Trial name
- NCT06482112
- Testing
- Efinopegdutide
- Where
- 39 sites in United States, Puerto Rico
- Volunteers
- 124 people
- Sponsor
- Merck Sharp & Dohme LLC
Infant Nutrition Disorders, Gastrointestinal Dysfunction
Management of Infant Digestive Disorders and Quality of Life
The objective of the study is to measure the evolution of the quality of life in infants between 0 and 5 months old, not breastfed and suffering from regurgitation or colic.
- Trial name
- NCT04462640
- Testing
- Management of Infant Digestive Disorders and Quality of Life
- Where
- France
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Metabolic Dysfunction-associated Steatotic Liver Disease, Chronic Hepatitis b
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ACT500 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Complicated With Chronic Hepatitis B
This study is a Phase Ib, multicenter randomized, double-blind, dose-escalation, placebo-controlled trial designed to evaluate the safety, tolerability, PK, and PD profiles of multiple-dose ACT500 in participants with metabolic…
- Trial name
- NCT07589400
- Testing
- ACT500 Tablets
- Where
- 4 sites in China
- Volunteers
- 24 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Hepatic Failure, Liver Failure
Cardiox Liver Function Test Pivotal Trial
Performance evaluation of LFT Dye Monitor System using ICG - plasma disappearance rate value (PDR) to assess liver function in normal patients as well as in patients with mild to severe hepatic impairment compared to manual Serum…
- Trial name
- LFT-0002 (NCT02552901)
- Testing
- 0.1 mg/kg ICG Dose, 0.5 mg/kg ICG dose
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Cardiox Corporation
Cancer, Bowel Dysfunction
Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
Study SB-767905/008 was a multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in participants…
- Trial name
- NCT00135577
- Testing
- alvimopan
- Where
- 40 sites in United States, Canada and 11 more
- Volunteers
- 67 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Ileus
Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus
Patients undergoing major abdominal surgery are at highest risk for developing Postoperative Ileus (POI), occurring in nearly all cases.
- Trial name
- NCT00205842
- Testing
- alvimopan
- Where
- United States
- Volunteers
- 660 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Fatty Liver Disease, Nonalcoholic
Investigation of the Efficacy of a Probiotic Mixture in Moderate Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Mechanistic Trial
The goal of this clinical trial is to evaluate whether a specific probiotic mixture can improve liver health in adults with moderate metabolic dysfunction-associated steatotic liver disease (MASLD).
- Conditions
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Fatty Liver Disease, Nonalcoholic, Overweight (BMI > 25)
- Trial name
- NCT07193927
- Testing
- Lactiplantibacillus plantarum Probiotic Mixture
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- AB Biotics, SA
Non-alcoholic Fatty Liver Disease
A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and…
- Trial name
- ZENITH-1 (NCT07221227)
- Testing
- Efimosfermin alfa
- Where
- 91 sites in United States, Australia and 7 more
- Volunteers
- 1,200 people
- Sponsor
- GlaxoSmithKline
Urinary Incontinence, Fecal Incontinence
Safety and Performance of UCon for the Treatment of the Symptoms of Overactive Bladder (OAB) / Bowel Dysfunction (BD)
This clinical investigation is a single-arm, prospective, multicentre, early feasibility study, which is used to evaluate the device design of UCon with respect to initial clinical safety and device performance in a small number…
- Conditions
- Urinary Incontinence, Fecal Incontinence, Urge Incontinence, Nocturia
- Trial name
- NCT05368246
- Testing
- UCon
- Where
- 3 sites in Denmark
- Volunteers
- 80 people
- Sponsor
- InnoCon Medical
Ileus
Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/ Postoperative Ileus
Patients undergoing major abdominal surgery are at highest risk for developing postoperative ileus (POI), occurring in nearly all cases.
- Trial name
- NCT00388479
- Testing
- Alvimopan
- Where
- United States
- Volunteers
- 666 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Acute-On-Chronic Liver Failure, Ascites
Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®
A Phase 2, multi-center, randomized, controlled, open-label study to evaluate the effects of the intraperitoneal, liposomal formulation VS-01 in patients with an acute episode of hepatic and/or extrahepatic organ dysfunctions and…
- Trial name
- NCT05900050
- Testing
- VS-01 on top of SOC, SOC (Control Group)
- Where
- 26 sites in United States, Belgium and 5 more
- Volunteers
- 15 people
- Sponsor
- Genfit
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called MASH. In this study, researchers are looking at the effect of ALN-CIDEB on reducing liver fat, liver…
- Trial name
- NCT07631637
- Testing
- ALN-CIDEB
- Where
- 16 sites in United States, Puerto Rico
- Volunteers
- 150 people
- Sponsor
- Regeneron Pharmaceuticals
Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
Evaluating the Pharmacokinetics and Safety of Miricorilant
A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis, Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Non-alcoholic Fatty Liver Disease (NAFLD)
- Trial name
- NCT07553663
- Testing
- Miricorilant
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Corcept Therapeutics
Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH)
A Real-world Assessment in Implementation of the MASH Patient Care Pathway in Chinese Population Using the Meinian Health Check-up Database
The primary objective of this study is to estimate the proportion of people with low/intermediate/high risk of advanced fibrosis in at risk Chinese population based on the European Association for the Study of the Liver (EASL)…
- Trial name
- IMPACT MASH (NCT06741111)
- Testing
- No treatment given
- Where
- India
- Volunteers
- 1,233,970 people
- Sponsor
- Novo Nordisk A/S
Constipation, Gastrointestinal Dysfunction
Effect of Polydextrose on Fecal Bulk and Bowel Function in Mildly Constipated Subjects
Polydextrose (PDX) (8-30g/day) has been reported to increase faecal bulk and consistency, leading to easier stool passage in healthy subjects.
- Trial name
- NCT05309837
- Testing
- Polydextrose
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Tate & Lyle
Ileus
Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus
Patients undergoing major abdominal surgery are at highest risk for developing postoperative ileus (POI), occurring in nearly all cases.
- Trial name
- NCT00388401
- Testing
- Alvimopan
- Where
- United States
- Volunteers
- 510 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Hyperoxaluria, Nonalcoholic Fatty Liver Disease
A Study of BMN 255 in Participants With Non-Alcoholic Fatty Liver Disease And Hyperoxaluria
The purpose of this study is to test the safety of BMN 255 and to learn about the effect BMN 255 has on you and your hyperoxaluria associated with NAFLD, and compare these effects with a placebo.
- Conditions
- Hyperoxaluria, Nonalcoholic Fatty Liver Disease, Kidney Stone
- Trial name
- NCT06138327
- Testing
- BMN 255
- Where
- 7 sites in United States
- Sponsor
- BioMarin Pharmaceutical
Postoperative Gastrointestinal Dysfunction
A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection
The objective of this study is to compare the efficacy of naldemedine versus placebo and to assess its effect on the time to gastrointestinal (GI) recovery following surgeries that include bowel resection and bowel transection.
- Trial name
- NCT04355169
- Testing
- Naldemedine
- Where
- 8 sites in United States
- Volunteers
- 2 people
- Sponsor
- Shionogi
Liver Cirrhosis
A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH)
This study is open to adults with a type of confirmed liver condition called compensated cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH).
- Trial name
- NCT07325526
- Testing
- BI 3802876
- Where
- 27 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Boehringer Ingelheim