Clinical trials: Intestinal Infection
HIV Enteropathy, Diarrhea With HIV
Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea
This study is being conducted to evaluate the safety and tolerability of crofelemer 125 mg twice a day, taken orally, over 48 weeks of therapy in human immunodeficiency virus-positive (HIV+) subjects with diarrhea.
- Trial name
- NCT01374490
- Testing
- Crofelemer
- Where
- 21 sites in United States
- Volunteers
- 250 people
- Sponsor
- Bausch Health Americas, Inc.
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the…
- Conditions
- Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications, Lymphoproliferative Disorders, Allogeneic Hematopoietic Cell Transplant
- Trial name
- ALLELE (NCT03394365)
- Testing
- tabelecleucel
- Where
- 71 sites in United States, Australia and 7 more
- Volunteers
- 115 people
- Sponsor
- Pierre Fabre Medicament
Shigellosis, Bacillary Dysentery
SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers
This is a first-in-human, single-center, single-blinded, observer-masked randomized, dose escalation (two doses), placebo-controlled study in healthy volunteers.
- Trial name
- NCT02797236
- Testing
- SF2a-TT15 vaccine, SF2a-TT15 vaccine + adjuvant
- Where
- Israel
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Sepsis, Multiple Organ Dysfunction Syndrome
Bovine Intestinal Alkaline Phosphatase for the Treatment of Patients With Sepsis
Eligible patients will receive either AP or matching placebo in a double blind, randomized design and following a 2:1 ratio. All medication will be given in addition to standard care for sepsis patients.
- Trial name
- NCT00430859
- Testing
- Alkaline Phosphatase
- Where
- 10 sites in Belgium, Netherlands
- Volunteers
- 37 people
- Sponsor
- AM-Pharma
Acquired Immunodeficiency Syndrome, Healthy Volunteers
Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in HIV+ Patients With Non-Infectious Diarrhea
This study is intended to evaluate: 1. Any changes in the gut microbiome from baseline compared to end of study in both healthy (HIV-negative) subjects and HIV+ patients with or without chronic diarrhea, following one month of…
- Conditions
- Acquired Immunodeficiency Syndrome, Healthy Volunteers, HIV/AIDS, HIV Diarrhea
- Trial name
- NCT04192487
- Testing
- Crofelemer delayed-release tablets 125mg
- Where
- 3 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Napo Pharmaceuticals, Inc.
Solid Tumor, Adult, Advanced Solid Tumor
A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101, a novel anti VISTA IgG1 monoclonal antibody as monotherapy or in combination with cemiplimab in patients with…
- Conditions
- Solid Tumor, Adult, Advanced Solid Tumor, Head and Neck Cancer, Breast Cancer
- Trial name
- NCT05864144
- Testing
- SNS-101 (anti-VISTA), Cemiplimab
- Where
- 10 sites in United States
- Volunteers
- 98 people
- Sponsor
- Sensei Biotherapeutics, Inc.
Pneumonia, Pneumococcal, Diabetes Mellitus
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
Primary care visits are a key aspect of clinical care focused on helping patients to close care gaps related to preventive care such as vaccination, diabetes testing, statin therapy and cancer screening.
- Conditions
- Pneumonia, Pneumococcal, Diabetes Mellitus, Breast Cancer, Colorectal Cancer
- Trial name
- NCT05799976
- Testing
- Text message nudge
- Where
- United States
- Volunteers
- 29,334 people, healthy volunteers welcome
- Sponsor
- Mitesh Patel
Clostridioides Difficile Infection
ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection
Cohort 1: Subjects who had a Clostridioides difficile infection (CDI) recurrence in study SERES-012 within 8 weeks of receipt of study drug will be eligible.
- Trial name
- NCT03183141
- Testing
- SER-109
- Where
- 107 sites in United States, Canada
- Volunteers
- 263 people
- Sponsor
- Seres Therapeutics, Inc.
Helicobacter Pylori Infection, Gastrointestinal Dysbiosis
Bacillus Probiotics With Bismuth Quadruple Therapy for Helicobacter Pylori Infection
Helicobacter pylori (H. pylori) is a very common gastrointestinal disease that colonises the human gastric mucosa and is a primary risk factor for chronic gastritis, peptic ulcer disease, and gastric cancer.
- Conditions
- Helicobacter Pylori Infection, Gastrointestinal Dysbiosis, Antibiotic-associated Adverse Events
- Trial name
- NCT07827170
- Testing
- RO water, LiveSpo CLAUSY, LiveSpo DIA30
- Where
- Vietnam
- Volunteers
- 336 people
- Sponsor
- Anabio R&D
Hemorrhoids, Hemorrhoids, Internal
SCI-Pex Study - Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids
The SCI-Pex study is a multicenter, prospective, non-controlled investigation on PexyEazy®, a new device for treatment of hemorrhoids based on the mucopexy method.
- Conditions
- Hemorrhoids, Hemorrhoids, Internal, Suture; Complications, Infection or Inflammation, Rectal Diseases
- Trial name
- SCI-Pex (NCT05782010)
- Testing
- PexyEazy
- Where
- 3 sites in Sweden
- Volunteers
- 35 people
- Sponsor
- Developeration AB
Infectious, Colitis
A Two-Arm, Multi-Centre Clinical Evaluation of the xTAG Gastrointestinal Pathogen Panel
The xTAG Gastrointestinal Pathogen Panel (xTAG GPP) is a PCR-based assay to detect the presence or absence of gastrointestinal (GI) pathogens from human stool specimens.
- Conditions
- Infectious, Colitis, Gastroenteritis
- Trial name
- NCT01326013
- Where
- 6 sites in United States, Canada
- Volunteers
- 1,534 people
- Sponsor
- Luminex Molecular Diagnostics
Cryptosporidiosis
A Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Participants
This study aims to characterize the pediatric cryptosporidiosis disease profile with respect to clinical presentation.
- Trial name
- NCT07716410
- Where
- 4 sites in Kenya, Malaysia and 1 more
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Solid Tumors, Genital Neoplasm, Female
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent and in combination with chemotherapy administered intravenously in participants…
- Conditions
- Advanced Solid Tumors, Genital Neoplasm, Female, Urogenital Neoplasms, Lung Neoplasm
- Trial name
- START-001 (NCT05592626)
- Testing
- STAR0602, Irinotecan (Camptosar), Docetaxel (Taxotere)
- Where
- 19 sites in United States, Canada and 2 more
- Volunteers
- 366 people
- Sponsor
- Marengo Therapeutics, Inc.
Colitis, HIV Infections
A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Large Intestine in Patients With AIDS
To attempt to demonstrate the efficacy of ganciclovir (DHPG) treatment of cytomegalovirus (CMV) colitis in AIDS patients by evaluating both clinical and virologic parameters.
- Trial name
- NCT00002273
- Testing
- Ganciclovir
- Where
- United States
- Sponsor
- Hoffmann-La Roche
Erythema Migrans of Lyme Disease
Effect of Saccharomyces Boulardii CNCM I-745 on Gut Microbiota in Patients Undergoing Antibiotic Therapy (in the Context of Erythema Migrans (Early Skin Form of Lyme Borreliosis))
The aim of this study is to assess the effect of Saccharomyces boulardii CNCM I-745 on gut microbiota in patients undergoing antibiotic therapy (in the context of erythema migrans (early skin form of Lyme borreliosis)).
- Trial name
- SUBLYME (NCT06451913)
- Testing
- Amoxicillin + Saccharomyces boulardii CNCM I-745, Stool samples, BSFS : Bristol Stool Form Scale
- Where
- Slovenia
- Volunteers
- 120 people
- Sponsor
- Biocodex
Diffuse Astrocytoma, IDH-Mutant, Glioblastoma, IDH-wildtype
Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
This multi-site, Phase 1/2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 alone for the treatment of patients with radiographically-confirmed…
- Conditions
- Diffuse Astrocytoma, IDH-Mutant, Glioblastoma, IDH-wildtype, Brain Metastases, Adult, Cervical Cancer
- Trial name
- NCT06047379
- Testing
- NEO212 Oral Capsule, Ipilimumab, Pembrolizumab
- Where
- 8 sites in United States
- Volunteers
- 134 people
- Sponsor
- Neonc Technologies, Inc.
Diarrhea, Travelers Diarrhea
Clinical Study to Assess the Efficacy of Once-daily IMM-124E (Travelan®) in a Controlled Human Infection Model.
This is a randomized, double-blind, placebo-controlled study to investigate a single daily dose of Travelan® protects healthy adult volunteers from moderate-to-severe diarrhea upon challenge with Enterotoxigenic Escherichia coli…
- Conditions
- Diarrhea, Travelers Diarrhea, Infectious Diarrhea
- Trial name
- NCT05933525
- Testing
- Travelan
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Immuron Ltd.
HIV-associated Enteropathy
Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
The purpose of the study is to evaluate the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g twice a day (BID) and SBI 5.0 g versus placebo on supporting nutrient…
- Trial name
- NCT01828593
- Testing
- Serum-derived bovine immunoglobulin protein isolate (SBI)
- Where
- 10 sites in United States
- Volunteers
- 103 people
- Sponsor
- Entera Health, Inc
Herpes Simplex, HIV Infections
A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients
To determine the safety and efficacy of oral valacyclovir hydrochloride ( 256U87 ) compared to acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients with CD4 counts = or > 100 cells/mm3.
- Trial name
- NCT00002084
- Testing
- Valacyclovir hydrochloride, Acyclovir
- Where
- 46 sites in United States
- Sponsor
- Glaxo Wellcome
Advanced Solid Tumor, Unresectable Solid Tumor
A Beta-only IL-2 ImmunoTherapY Study
This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a…
- Conditions
- Advanced Solid Tumor, Unresectable Solid Tumor, Clear Cell Renal Cell Carcinoma, Triple Negative Breast Cancer
- Trial name
- ABILITY-1 (NCT05086692)
- Testing
- MDNA11, Pembrolizumab (KEYTRUDA®)
- Where
- 28 sites in United States, Australia and 6 more
- Volunteers
- 160 people
- Sponsor
- Medicenna Therapeutics, Inc.