Clinical trials: Gastrointestinal Dysfunction
Autism, Autistic Disorder
Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism
The purpose of this study is to determine if human immunoglobulin given by mouth twice a day is effective in treating the persistent gastrointestinal (GI) problems such as diarrhea, constipation, abdominal pain, and bloating, in…
- Conditions
- Autism, Autistic Disorder, Child Development Disorders, Pervasive, Gastrointestinal Diseases
- Trial name
- NCT00110708
- Testing
- Oralgam (human immunoglobulin)
- Where
- 22 sites in United States
- Volunteers
- 120 people
- Sponsor
- PediaMed Pharmaceuticals
Bowel Dysfunction
Exploratory Investigation on a Novel Catheter
An exploratory, pre-market, open, prospective, interventional, clinical investigation at a limited number of centers for proof of concept of a new catheter.
- Trial name
- NCT05644912
- Testing
- Transanal irrigation (TAI)
- Where
- Netherlands
- Volunteers
- 13 people
- Sponsor
- Wellspect HealthCare
Niemann-Pick Disease, Type C
VTS-270 to Treat Niemann-Pick Type C1 (NPC1) Disease
Due to different study designs, the sponsor separated Part C into a separate registration (NCT04958642), leaving Parts A/B here in NCT02534844.
- Trial name
- NCT02534844
- Testing
- Parts A/B: Adrabetadex
- Where
- 29 sites in United States, Australia and 7 more
- Volunteers
- 56 people
- Sponsor
- Mandos LLC
Neoplasm Metastases, Hepatic Insufficiency
A Pharmacokinetic Study of Trabectedin in Patients With Advanced Malignancies and Hepatic Dysfunction
The purpose of this study is to characterize the pharmacokinetics (blood levels) of trabectedin after administration to patients with advanced malignancies and hepatic (liver) dysfunction.
- Trial name
- NCT01273493
- Testing
- Trabectedin, Dexamethasone
- Where
- 11 sites in United States, Belgium and 2 more
- Volunteers
- 15 people
- Sponsor
- Janssen Research & Development, LLC
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
- Trial name
- NCT06318169
- Testing
- Pegozafermin
- Where
- 370 sites in United States, Argentina and 25 more
- Volunteers
- 1,350 people
- Sponsor
- Hoffmann-La Roche
Metabolic Dysfunction-Associated SteatoHepatitis (MASH)
A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition
This study is researching an investigational drug, ALN-HSD called "study drug". This study is focused on participants who are known to have Metabolic dysfunction-Associated SteatoHepatitis (MASH).
- Trial name
- NASHGEN-2 (NCT05519475)
- Testing
- ALN-HSD
- Where
- 71 sites in United States, Japan and 2 more
- Volunteers
- 120 people
- Sponsor
- Regeneron Pharmaceuticals
Hepatic and Hepatobiliary Disorders
Essentiale® Paste in Patients With Gastrointestinal Symptoms in Acute or Chronic Liver Diseases
Primary Objective: To assess safety of Phosphatidylcholine paste 600 mg (ESSENTIALE® paste) oral 3 times a day for 12 weeks in patients with gastrointestinal symptoms in acute and chronic liver diseases.
- Trial name
- EPLID (NCT02517385)
- Testing
- Phosphatidylcholine
- Where
- Russia
- Volunteers
- 147 people
- Sponsor
- Sanofi
Autism Spectrum Disorder, Gastrointestinal Dysfunction
ASC - Autism Study
The ASC - Autism Pilot Study is a single center randomized open dose titrating phase I clinical intervention pilot trial with the aim of investigating safety and treatment effect of an allogeneic adipose tissue derived…
- Conditions
- Autism Spectrum Disorder, Gastrointestinal Dysfunction, Leaky Gut Syndrome, Mesenchymal Stromal Cells
- Trial name
- NCT05602116
- Testing
- Adipose tissue derived mesenchymal stromal/stem cells (Cell2Cure®)
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- Cell to Cure ApS
Fungal Infection, Acute Myelogenous Leukemia
Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115)
The purpose of this study is: to explore the potential for different dosing strategies of posaconazole oral suspension (POS) to increase plasma levels and to profile the pharmacokinetics of these dosing strategies in patients…
- Conditions
- Fungal Infection, Acute Myelogenous Leukemia, Neutropenia
- Trial name
- NCT00686543
- Testing
- Posaconazole
- Volunteers
- 75 people
- Sponsor
- Merck Sharp & Dohme LLC
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.
Liver Dysfunction
Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone in Volunteers With Impaired Hepatic Function
This is a multicenter, non-randomized, single-dose, parallel-group study. Each subject will receive a subcutaneous dose of MNTX.
- Trial name
- NCT01367522
- Testing
- SC Methylnaltrexone (MNTX)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Chronic Hepatitis B Virus Infection, Chronic Hepatitis C Virus Infection
Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal Dysfunction
The purpose of this study is to determine the effect of renal impairment on pharmacokinetics (PK) of BMS-914143.
- Trial name
- PK (NCT01708889)
- Testing
- BMS-914143 (Peginterferon Lambda-1a)
- Where
- 3 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Liver Diseases, Hepatic Insufficiency
A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease
The main purpose of this study is to measure how much of the study drug called baricitinib gets into the blood stream and how long it takes the body to get rid of it. Healthy participants and those with liver disease may enroll.
- Trial name
- NCT01870388
- Testing
- Baricitinib
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Irritable Bowel Syndrome, Gastrointestinal Diseases
Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome
The objective of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of Skal Pro in alleviating symptoms, enhancing stool consistency, improving quality of life, and addressing psychological…
- Conditions
- Irritable Bowel Syndrome, Gastrointestinal Diseases, Colonic Diseases, Functional, Intestinal Disease
- Trial name
- NCT06271538
- Testing
- Skal Pro
- Where
- Malaysia
- Volunteers
- 57 people
- Sponsor
- EP Plus Group Sdn Bhd
Unspecified Adult Solid Tumor, Chemotherapy
Irinotecan in Treating Patients With Refractory Solid Tumors and Liver Dysfunction
Drugs used in chemotherapy us different ways to stop tumor cells from dividing so they stop growing or die. Irinotecan may be effective in treating patients with refractory solid tumors and liver dysfunction.
- Conditions
- Unspecified Adult Solid Tumor, Chemotherapy, Liver Dysfunction, Neoplasms, Solid Tumor
- Trial name
- NCT00037804
- Testing
- Irinotecan
- Where
- 4 sites in United States
- Sponsor
- Pfizer
Pelvic Organ Prolapse
Restorelle® Mesh Versus Native Tissue Repair for Prolapse
The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle.
- Trial name
- NCT02162615
- Testing
- Restorelle Direct Fix A, Restorelle Direct Fix P, Native Tissue Repair Anterior
- Where
- 49 sites in United States, Australia and 4 more
- Volunteers
- 810 people
- Sponsor
- Coloplast A/S
Irritable Bowel Syndrome With Diarrhea (IBS-D)
Efficacy, Safety and Tolerability of DNK333 (25 mg Bid) in Women With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
The purpose of this study is to evaluate the efficacy of DNK333 compared to placebo for relieving symptoms of IBS-D in female patients.
- Trial name
- NCT00394173
- Testing
- DNK333
- Where
- 43 sites in United States, Canada
- Volunteers
- 180 people
- Sponsor
- Novartis
Healthy, Fatty Liver
Development of a Non-invasive Screening Tool to Predict Metabolic Dysfunction-associated Steatotic Liver Disease
A generic screening study to establish structural and/or functional baselines of specific organs.
- Conditions
- Healthy, Fatty Liver, MASLD, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
- Trial name
- MASLD (NCT04873258)
- Testing
- Bioimpedence Vector Analysis
- Where
- United Kingdom
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Richmond Research Institute
Liver Dysfunction, Rejection, Transplant
Evaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant Rejection
This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and prevent kidney transplant rejection.
- Conditions
- Liver Dysfunction, Rejection, Transplant, Transplantation, Liver
- Trial name
- NCT00117689
- Testing
- Thymoglobulin, Corticosteroid, Tacrolimus
- Where
- 16 sites in United States, Canada
- Volunteers
- 75 people
- Sponsor
- Genzyme, a Sanofi Company
Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver Disease
Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH)
This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy on TVB-2640 in subjects with non-alcoholic steatohepatitis (NASH).
- Trial name
- NCT04906421
- Testing
- TVB-2640
- Where
- 117 sites in United States, Canada and 2 more
- Volunteers
- 168 people
- Sponsor
- Sagimet Biosciences Inc.