Clinical trials: Gastrointestinal Function
Functional Gastrointestinal Disorders, Vagus Nerve Autonomic Disorder
A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders
The purpose of this study is to see if using a micro-current through a device called a TENS (Transcutaneous Electrical Nerve Stimulator) unit helps to improve functional gastrointestinal disorder (FGID) symptoms in children by…
- Conditions
- Functional Gastrointestinal Disorders, Vagus Nerve Autonomic Disorder, Irritable Bowel Syndrome, Nausea
- Trial name
- NCT04247100
- Testing
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Gisela Grotewold Chelimsky
Functional Gastrointestinal Disorders
Defining Adolescent Nausea Through Brain Imaging and Neurostimulation Response
This study evaluates the efficacy of auricular neurostimulation via an non-invasive percutaneous electrical nerve field stimulator (PENFS) in adolescents with functional nausea.
- Trial name
- NCT03675321
- Testing
- Active Auricular Neurostimulation
- Where
- United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Medical College of Wisconsin
Infantile Colic, Infantile Functional Gastrointestinal Disorders
A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants.
- Trial name
- NCT00655083
- Testing
- Nepadutant
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Menarini Group
Hepatic Steatosis, Bariatric Surgery Candidate
Hepatic Mitochondrial Function in Youth
Assess the impact of bariatric surgery on hepatic energy metabolism and glucose and insulin dynamics in obese youth
- Conditions
- Hepatic Steatosis, Bariatric Surgery Candidate, Adolescent Obesity, Obesity
- Trial name
- MANGO (NCT03587727)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Colorado, Denver
Functional Gastrointestinal Disorders
Behavioral Therapy in Patients With Rumination
The study aim is to diagnose patients with the rumination syndrome defined by the Rome IV criteria and to treat them with behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed…
- Trial name
- NCT05232097
- Testing
- Behavioral therapy, Physiotherapy
- Where
- 2 sites in Finland
- Volunteers
- 11 people
- Sponsor
- Helsinki University Central Hospital
Functional Abdominal Pain, Functional Dyspepsia
Efficacy of Open Label Placebo in Children With FGIDs
This study is aimed at investigating the efficacy of placebo for symptom relief in children with abdominal pain related functional gastrointestinal disorders.
- Conditions
- Functional Abdominal Pain, Functional Dyspepsia, Irritable Bowel Syndrome, Functional Gastrointestinal Disorders
- Trial name
- Placebo (NCT02389998)
- Testing
- Hyoscyamine
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Boston Children's Hospital
Cystic Fibrosis
A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Participants With Cystic Fibrosis (CF)
This study will evaluate the effects of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) on cough and physical activity using wearable technology in CF participants.
- Trial name
- NCT04969224
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 19 sites in Australia, Belgium and 2 more
- Volunteers
- 82 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF…
- Trial name
- NCT03447249
- Testing
- VX-659/TEZ/IVA, IVA
- Where
- 101 sites in United States, Australia and 9 more
- Volunteers
- 385 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Autism Spectrum Disorder
Efficacy of Vivomixx on Behaviour and Gut Function in Autism Spectrum Disorder
The purpose of this study is to assess the effects of 3 months supplementation with the multi strain probiotic Vivomixx on the overall function, aberrant behaviours and frequency of gastrointestinal symptoms in children with…
- Trial name
- VIVO-ASD (NCT03369431)
- Testing
- Vivomixx
- Where
- United Kingdom
- Volunteers
- 69 people
- Sponsor
- University College, London
Cystic Fibrosis
Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
Many people with Cystic Fibrosis (CF) are troubled by symptoms from their stomach and bowels: their gastrointestinal (GI) tract.
- Trial name
- GIFT-CF1 (NCT03566550)
- Testing
- MRI scans
- Where
- United Kingdom
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Nottingham University Hospitals NHS Trust
Obstructed Defecation Syndrome, Rectocele
Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM
The stapled transanal rectal resection (STARR procedure) is an effective treatment for obstructed defecation syndrome (ODS) caused by intussusception and rectocele.
- Conditions
- Obstructed Defecation Syndrome, Rectocele, Intussusception, SNS
- Trial name
- STARR (NCT00673400)
- Testing
- Stapled transanal rectum resection
- Where
- Switzerland
- Volunteers
- 52 people
- Sponsor
- Cantonal Hospital of St. Gallen
Diabetes Mellitus, Type 1
A Research Trial of Aralast in New Onset Diabetes (RETAIN)
The drug Alpha-1 Antitrypsin (AAT, Aralast NP) is being tested in this study as an anti-inflammatory drug (a medication that decreases inflammation, which is part of the body's normal ability to fight infection and respond to…
- Trial name
- RETAIN (NCT01183468)
- Testing
- Aralast NP 45 mg dose, Aralast NP 90 mg dose, Aralast NP 180 mg dose
- Where
- 15 sites in United States
- Volunteers
- 17 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cystic Fibrosis
A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)
The purpose of this study evaluates the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who were heterozygous for F508del and a minimal function mutation (F/MF participants).
- Trial name
- NCT05033080
- Testing
- VX-121/TEZ/D-IVA, ELX/TEZ/IVA, IVA
- Where
- 139 sites in United States, Australia and 10 more
- Volunteers
- 435 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Functional Gastrointestinal Disorders, Irritable Bowel Syndrome
Does Improving Vagal Tone Increase Mitochondrial Bioenergetics
This study evaluates the effect of auricular neurostimulation on mitochondrial bioenergetics and inflammation through vagal nerve modulation via non-invasive percutaneous electrical nerve field stimulator in children with…
- Conditions
- Functional Gastrointestinal Disorders, Irritable Bowel Syndrome, Dyspepsia, Functional Abdominal Pain Syndrome
- Trial name
- NCT03931330
- Testing
- Percutaneous neurostimulation
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Medical College of Wisconsin
Cystic Fibrosis
Trikafta in Cystic Fibrosis Patients
This clinical study will enroll 42 participants without the F508del mutation, carrying partial function or N1303K mutations not approved for Trikafta, and who are not expected to be approved for CFTR modulator treatment in the…
- Trial name
- NCT03506061
- Testing
- Trikafta
- Where
- 2 sites in United States
- Volunteers
- 42 people
- Sponsor
- Emory University
Cystic Fibrosis
A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation
The purpose of this study is to evaluate the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who are homozygous for F508del, heterozygous for F508del and a gating (F/G) or residual…
- Trial name
- NCT05076149
- Testing
- VX-121/TEZ/D-IVA, ELX/TEZ/IVA, IVA
- Where
- 170 sites in United States, Australia and 18 more
- Volunteers
- 597 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Irritable Bowel Syndrome
Chronic Gastrointestinal Sequelae of an Acute Outbreak of Bacterial Gastroenteritis in Walkerton Ontario
Acute Bacterial dysentery leads to chronic symptoms of disturbed bowel habit in a minority of individuals. This condition known as post infectious irritable bowel syndrome (PI-IBS) remains poorly understood.
- Trial name
- NCT00235326
- Where
- Canada
- Volunteers
- 4,561 people, healthy volunteers welcome
- Sponsor
- McMaster University
Cystic Fibrosis
Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic Fibrosis
To evaluate the change in forced expiratory volume (FEV1) from baseline to Day 28-30 between Cipro Inhale-treated and placebo-treated subjects after a 4-week treatment period.
- Trial name
- NCT00645788
- Testing
- Ciprofloxacin (Cipro Inhale, BAYQ3939)
- Where
- 86 sites in United States, Australia and 7 more
- Volunteers
- 288 people
- Sponsor
- Bayer
Cystic Fibrosis
A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Particpants 6 Years and Older and F/MF Genotypes
The study evaluates the long-term safety and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination (TC) in participants with CF who are 6 years of age and older with F/MF genotypes.
- Trial name
- NCT04545515
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 34 sites in Australia, Canada and 8 more
- Volunteers
- 120 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Functional Gastrointestinal Disorders
Systematic Pediatric Assessment of Rome Criteria (SPARC)
While gastroenterologists care for many of the pediatric patients with Functional gastrointestinal disorders (FGIDs), the majority of the burden continues to be borne by general pediatricians, especially with respect to initial…
- Trial name
- SPARC (NCT04773158)
- Testing
- Clinical Decision Support
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Indiana University