Clinical trials: Intestinal Inflammation
Crohn's Disease
Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease
To provide open-label re-treatment with PROCHYMAL to participants enrolled in companion Protocol 603 to evaluate the safety in participants with active Crohn's disease who are resistant to standard Crohn's disease therapies.
- Trial name
- NCT01233960
- Testing
- Prochymal®
- Where
- 20 sites in United States, Australia and 1 more
- Volunteers
- 73 people
- Sponsor
- Mesoblast, Inc.
Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn
Infant Formula Feeding and Necrotizing Enterocolitis in Newborns
Necrotizing enterocolitis (NEC) is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality.
- Conditions
- Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Cows Milk Allergy
- Trial name
- NCT05121753
- Testing
- Survey investigating Infant formula feeding in newborns
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Neuroganics LLC
Stress
BALANCE Study: Beneficial Effects of A Diverse Prebiotic Fibre bLend on Affect, iNflammation, Cognition, and the Gut microbiomE
This clinical trial will investigate whether a powdered prebiotic fibre blend, at two doses, can improve perceived stress levels in healthy adults with mild-severe stress levels.
- Trial name
- BALANCE (NCT07477470)
- Testing
- Prebiotic fibre blend
- Where
- United Kingdom
- Volunteers
- 120 people
- Sponsor
- Myota GmbH
Late Onset Neonatal Sepsis, Necrotizing Enterocolitis
Effects of Oral Probiotic Supplementation on the Clinical Status of Very-low-birth-weight Preterm Neonates.
The purpose of this study was to evaluate the safety of a probiotic foodstuff and its influence on emergence and development of natural intestinal flora and the clinical status of premature very low birth weight neonates.
- Conditions
- Late Onset Neonatal Sepsis, Necrotizing Enterocolitis, Infant, Very Low Birth Weight
- Trial name
- NCT02073214
- Testing
- Probiotic
- Volunteers
- 182 people
- Sponsor
- IBSS Biomed S.A.
Inflammation
Efficacy and Safety of Bovine Intestinal Alkaline Phosphatase (bIAP) During Heart Surgery
This multi-centre prospective, randomised, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of bovine intestinal alkaline phosphatase (bIAP) in reducing the pro-inflammatory post-surgical…
- Trial name
- APPIRED-II (NCT01144611)
- Testing
- bIAP bolus and 8h infusion
- Where
- Netherlands
- Volunteers
- 53 people
- Sponsor
- Alloksys Life Sciences B.V.
Overweight or Obesity, Healthy
Berries, Inflammation, and Gut Microbiome
The primary objectives are to characterize changes in indices of systemic and gut inflammation, assess host- and microbial-derived metabolite pools, and describe and link functional metagenomics and metatranscriptomic alterations…
- Trial name
- NCT04100200
- Testing
- Mixed berries, FOS, Control
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
Microbiome, Metabolic Syndrome
Dietary Fibers Effect on the Gut Microbiota Composition
The randomized double-blinded placebo-controlled multicenter study will be held in parallel groups. During 5 weeks the efficacy of different endpoints as a measure of response to the daily intake of dietary fibers (8 g of either…
- Conditions
- Microbiome, Metabolic Syndrome, Cardiovascular Risk Factor, Inflammation
- Trial name
- NCT04114513
- Testing
- Maltodextrin, Inulin, Pectin
- Where
- Russia
- Volunteers
- healthy volunteers welcome
- Sponsor
- Atlas Biomed
Functional and Motility Related Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional Dyspepsia
A Pharmacy-based Study to Learn More About How Well Iberogast Works, How it Affects the Body, How it is Used, and User Satisfaction in Patients With Functional and Motility-related (Stomach and Bowel Movement-related) Gastrointestinal Diseases, Including Irritable Bowel Syndrome
Researchers want to learn more about the day-to-day use of Iberogast in people who have functional and motility-related gastrointestinal (stomach and bowel) diseases.
- Trial name
- NCT04993989
- Testing
- Iberogast (STW5, BAY98-7411)
- Where
- Germany
- Volunteers
- 843 people
- Sponsor
- Bayer
Inflammation, Crohn's Disease
A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's Disease
This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn's disease.
- Trial name
- NCT01751152
- Testing
- NNC0114-0006
- Where
- 28 sites in United States, Bulgaria and 4 more
- Volunteers
- 53 people
- Sponsor
- Novo Nordisk A/S
Acute Respiratory Distress Syndrome, Coronavirus
Pemziviptadil (PB1046), a Long-acting, Sustained Release Human VIP Analogue, Intended to Provide Clinical Improvement to Hospitalized COVID-19 Patients at High Risk for Rapid Clinical Deterioration and Acute Respiratory Distress Syndrome (ARDS).
This is a multicenter, randomized, double-blind, parallel group study to investigate the efficacy of pemziviptadil (PB1046) by improving the clinical outcomes in hospitalized COVID-19 patients at high risk for rapid clinical…
- Conditions
- Acute Respiratory Distress Syndrome, Coronavirus, Hypoxic Respiratory Failure, Hypoxemic Respiratory Failure
- Trial name
- VANGARD (NCT04433546)
- Testing
- Pemziviptadil (PB1046), Low Dose (10 mg) Control
- Where
- 4 sites in United States
- Volunteers
- 54 people
- Sponsor
- PhaseBio Pharmaceuticals Inc.
Ulcerative Colitis
A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis
The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well…
- Trial name
- NCT06254950
- Testing
- TAK-279
- Where
- 141 sites in United States, Australia and 20 more
- Volunteers
- 213 people
- Sponsor
- Takeda
Low-grade Inflammation, Increased Intestinal Permeability
Probiotics Against Low Grade Inflammation and Increased Intestinal Permeability in the Elderly
The purpose of this study is to evaluate the ability of a blend of berries and probiotics in reducing low-grade inflammation and intestinal permeability in the elderly. The intervention period is one month.
- Trial name
- NCT02342496
- Testing
- Active, only probiotics, Active, blend of berries and probiotics
- Where
- Sweden
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Probi AB
Inflammatory Bowel Diseases, Colitis, Ulcerative
Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes
The purpose of this study is to determine if a relationship exists between Week 6 vedolizumab therapeutic drug monitoring (TDM) and Week 30 Faecal calprotectin (FCP).
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
- Trial name
- VEDO TDM RWE (NCT04567628)
- Testing
- No Intervention
- Where
- Canada
- Volunteers
- 7,873 people
- Sponsor
- Takeda
Aging Well
Gut Health, Inflammation, Hormones
Pilot exploratory study on the effect of a Bifidobacterium breve extract, as VMK223, on plasma inflammatory markers, saliva hormones, gut microbiota and tolerance in females over 50years old.
- Trial name
- NCT04267731
- Testing
- VMK223, Cellulose
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Vemico Ltd.
Crohn's Disease
An Efficacy and Safety Study of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease
The purpose of this study is to see if Epanova™ is able to maintain the symptomatic remission in subjects with Crohn's Disease who are responding to steroid induction therapy.
- Trial name
- NCT00074542
- Testing
- Epanova™ (Omega-3 Free Fatty Acids)
- Where
- 31 sites in United States, Canada
- Volunteers
- 364 people
- Sponsor
- Tillotts Pharma AG
Refractory Reflux Esophagitis
Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)
This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of…
- Trial name
- NCT01669811
- Testing
- Esomeprazole (D961H) twice daily, Esomeprazole (D961H) once daily
- Where
- 63 sites in Japan
- Volunteers
- 1,398 people
- Sponsor
- AstraZeneca
Inflammation, Crohn's Disease
Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease
This trial is conducted in Europe and North America. The aim of the trial is to assess disease activity and safety in subjects with moderately to severely active Crohn's disease (CD) when treated with NNC 0142-0000-0002.
- Trial name
- NCT01203631
- Testing
- NNC 0142-0000-0002
- Where
- 23 sites in United States, Belgium and 6 more
- Volunteers
- 78 people
- Sponsor
- Janssen Research & Development, LLC
Irritable Bowel Syndrome
Safety and Efficacy Study of PEA and Polydatin on Intestinal Inflammation and Visceral Hyperalgesia in IBS Patients
Despite the pathophysiology of IBS remains largely unsettled, several mechanisms have been proposed to explain symptom generation.
- Trial name
- CMD-IBS09(2) (NCT01370720)
- Testing
- Recoclix
- Where
- Italy
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- MARIA CRISTINA COMELLI
Inflammatory Bowel Diseases, Short Bowel Syndrome
Effects of an Amino Acid Mixture on Gastrointestinal Function, Inflammation and Fluid Balance: A Pilot Study in Patients With Inflammatory Bowel Disease
This pilot study will examine the benefit of this amino acid based hydration solution in patients with IBD who have undergone a total colectomy and have either ileostomies or jpouches.
- Conditions
- Inflammatory Bowel Diseases, Short Bowel Syndrome, Ileostomy - Stoma
- Trial name
- NCT03451253
- Testing
- amino acid mixture beverage, glucose-based sports drink
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- Entrinsic Bioscience Inc.
IBS - Irritable Bowel Syndrome, Inflammation
Study of Inflammatory Markers and Symptom Severity in Personalized Nutritional Intervention in IBS
Irritable Bowel Syndrome (IBS) is a widespread disease with variable symptoms that have an important impact on the quality of life.
- Trial name
- NCT04348760
- Testing
- Rotation Diet
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- GEK Srl