Phase 1 N=10 Oral AGY for Celiac Disease
Celiac Disease
Primary: Number of Participants for Which Treatment Was Concluded to be Safe — 6; 18; 4; 5 participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=50 Rifaximin for the Treatment of Persistent Symptoms in Patients With Celiac Disease
Celiac Disease
Primary: Baseline Gastrointestinal Symptom Rating Scale (GSRS) Score — 2.7; 2.8 Score on a scale
Early Phase 1 N=18 Gluten Challenge Study in Celiac Disease Participants (MK-0000-402)
Celiac Disease
Primary: Percentage of α1- and α2-gliadin-reactive CD4+ T Cells in Peripheral Blood Before Gluten Challenge — 0.00364; 0.00016; 0.00049; 0.00005 Percentage of T cells
N/A N=16 Assessment of Immune Activation and Tolerance in Celiac Disease During Gluten Challenge
Celiac Disease
Primary: Change From Baseline in Small Intestine Histology Based on Villous Height to Crypt Depth (Vh:Cd) Ratio — 2.10; 2.30; -0.06; -1.53 ratio — p=0.385
Phase 2 N=153 A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet
Celiac Disease
Primary: Change in Weekly Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) Symptom Severity Score From Baseline to Week 12 — -0.128; -0.111 score on a scale — p==0.847
Phase 2 N=34 Study of the Safety, Pharmacodynamics, Efficacy, and PK of TIMP-GLIA in Subjects With Celiac Disease
Celiac Disease
Primary: Change From Baseline in Interferon-Gamma Spot Forming Units (IFN-gamma SFUs) in a Gliadin-specific Enzyme-linked Immunospot (ELISpot) at Day 20 — 3.08; 1.98; 2.01; 17.57…
Phase 2 N=64 A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease
Celiac Disease
Primary: Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12 — -62.66; -53.78; -60.17 percent change — p=0.7271
Phase 2 N=28 Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Type II Refractory Celiac Disease
Type II Refractory Celiac Disease (RCD-II) · In-situ Small Bowel T-cell Lymphoma
Primary: Percent Change From Baseline in the Percentage of Aberrant Intestinal Intraepithelial Lymphocytes With Respect to All Intraepithelial Lymphocytes — 2.45; 7.30 percent…
N/A N=20 Serum Markers in Gluten Challenge
Celiac Disease
Primary: Crypt Depth to Villous Height Ratio — 2.05; 4.33; 1.19; 2.02 ratio — p=0.670
Phase 2 N=388 PRV-015 in Gluten-free Diet Non-responsive Celiac Disease
Celiac Disease
Primary: Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Abdominal Symptoms Domain Score Through Week 24 — -1.32; -1.28; -1.21; -1.28 score on a scale…
Phase 1 N=23 Study of the Safety, Tolerability and Pharmacokinetics of TIMP-GLIA in Subjects With Celiac Disease
Celiac Disease
Primary: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 1; 2; 3; 3 Participants
Phase 2 N=12 Desensitising Celiac Disease Patients With the Human Hookworm
Celiac Disease
Primary: Duodenal Villus Height:Crypt Depth — 2.73; 2.73 Ratio — p=0.693
N/A N=45 The Effect of Gluten-free Diet on New Onset Type 1 Diabetes (T1D)
Type 1 Diabetes
Primary: Change in C-peptide Area Under the Curve Measured by Mixed-meal Tolerance Test (MMTT) Between Group on GFD and Standard Gluten-containing Diet. — 1539; 1173 pmol*min/l…
Phase 1 N=28 A Study of PVP001, PVP002, and PVP003 in Healthy Adults and PVP001 and PVP002 in Adults With Celiac Disease
Digestive System Disease
Primary: Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002 — 0; 0; 0; 0 Participants
Phase 2 N=55 A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease
Celiac Disease · Coeliac Disease
Primary: Changes From Baseline in Villous Height to Crypt Depth (Vh:Cd) as Assessed by Esophagogastroduodenoscopy With Biopsy After 2-week Gluten Challenge (GC) — -0.85; -0.61…
N/A N=6 Evaluate the Use of Optical Frequency Domain Imaging (OFDI) for Celiac Disease in Children, Adolescents and Young Adults
Celiac Disease
Primary: Number of Subjects With Changes of Villous Architecture Undergoing OFDI Imaging — 6 Participants
N/A N=29 Dietary Triggers of Gastrointestinal Symptoms in IBS Patients
Irritable Bowel Syndrome
Primary: Number of Participants With Worsening Irritable Bowel Syndrome (IBS) Symptoms Based on IBS-SSS — 8; 10; 11 Participants
Phase 1 N=41 Assessment of KAN-101 in Celiac Disease (ACeD)
Celiac Disease
Primary: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) — 4; 3; 2; 3 Participants
N/A N=53 Congenital Sucrase-Isomaltase Deficiency (CSID) Genetic Prevalence Study (GPS)
Congenital Sucrase-isomaltase Deficiency (CSID)
Primary: Prevalence of CSID Genetic Variants — 27; 0 Participants
Phase 2 N=3 Study of Safety, Tolerability, and Efficacy of Ustekinumab for Symptomatic Gastrointestinal Inflammation Associated With Common Variable Immunodeficiency
Gastrointestinal Inflammation Associated With CVID · CVID Enteropathy
Primary: Number of Participants With Increase in Infection or Serious Adverse Events (SAEs) Related to Single Dose Administration of Ustekinumab — 0 participants
N/A N=19 Crohn Disease Exclusion Diet After Single Medication De-escalation
Crohn Disease
Primary: Sustained Relapse-free Remission — 6; 5 Participants
N/A N=191 Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease
Crohn Disease
Primary: Percentage of Participants That Achieved Symptomatic Remission at Week 6 — 40; 46 Participants
Phase 2 N=45 Diet Treatment Glucose Transporter Type 1 Deficiency (G1D)
GLUT1DS1 · Epilepsy · Glut1 Deficiency Syndrome 1, Autosomal Recessive
Primary: Neuropsychological Score of Sustained Attention — 11 Participants
N/A N=50 Study of the Relationship Between Glycogen Storage Disease Type Ia and Inflammatory Bowel Disease
Inflammatory Bowel Disease · Glycogen Storage Disease Type Ia
Primary: Serologic, Genetic and Inflammatory Markers Consistent With Inflammatory Bowel Disease — 11 participants testing positive
N/A N=98 Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease
Crohn's Disease
Primary: Diagnostic Yield in Suspected Crohn's Patients (CE Prior to IC vs. IC and SBFT) — 97.3; 57.3 percentage of yield — p=<0.0001
Phase 4 N=23 Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®
Gastrointestinal Lesions · Signs and Symptoms, Digestive
Primary: GI Mucosal Lesions Change and Clinical Symptoms Using The Gastrointestinal Symptom Rating Scale (GSRS) Score — 2.99; 2.19 GSRS score — p=0.05
Phase 3 N=111 Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate
Autoimmune Disease
Primary: Changes in GI Symptom Severity After Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) — 2.28; 2.02; -0.28 Scores on a scale
N/A N=18 Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis
Eosinophilic Gastroenteritis
Primary: Percent of Participants in Complete Histologic Remission — 100 percentage of participants
N/A N=15 Autoimmune Protocol Diet and Inflammatory Bowel Disease
Crohn Disease · Ulcerative Colitis · Inflammatory Bowel Diseases
Primary: Number of Participants With Clinical Remission for Crohn's Disease — 6 Participants
Phase 3 N=89 Mucosal Healing Study in Crohn's Disease (CD)
Crohn's Disease
Primary: Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments — -6.47 score on a scale