Clinical trials: Malabsorption Syndromes
Celiac Disease
Study of the Safety, Pharmacodynamics, Efficacy, and PK of TIMP-GLIA in Subjects With Celiac Disease
Subjects enrolled in this study will be evaluated for immune responses and histological changes in the small bowel following 2 doses of TIMP-GLIA or placebo and a 14-day oral gluten challenge.
- Trial name
- NCT03738475
- Testing
- TIMP-GLIA
- Where
- 8 sites in United States
- Volunteers
- 34 people
- Sponsor
- Takeda
Short Bowel Syndrome
Study of Teduglutide in Japanese Participants With Short Bowel Syndrome
The objectives of this clinical study are to evaluate the safety, efficacy, and pharmacokinetics (PK) of teduglutide in Japanese participants with short bowel syndrome (SBS) who are dependent on parenteral nutrition/intravenous…
- Trial name
- NCT03663582
- Testing
- Teduglutide, Syringe, Needle
- Where
- 5 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Shire
Bile Acid Malabsorption, Cholelithiasis
Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy
Investigate serial plasma samples of fibroblast growth factor 19 (FGF19) after oral stimulation with chenodeoxycholic acid in the same subjects before and after elective cholecystectomy
- Trial name
- BACH (NCT03168555)
- Testing
- chenodeoxycholic acid
- Where
- Denmark
- Volunteers
- 23 people
- Sponsor
- Zealand University Hospital
Short Bowel Syndrome
Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome
The purpose of the study is to evaluate the safety, efficacy/pharmacodynamics (PD) and pharmacokinetics (PK) of teduglutide treatment in infants with short bowel syndrome (SBS) dependent on parenteral (PN) support.
- Trial name
- NCT03571516
- Testing
- Teduglutide, Standard Medical Therapy, Syringe
- Where
- 8 sites in Finland, France and 2 more
- Volunteers
- 10 people
- Sponsor
- Shire
Hyperhomocysteinemia, Obesity
Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children
The purpose of the present study was to determine whether folic acid supplementation could reduce plasma homocysteine in obese children and to determine the association between dietary folate, serum folate and homocysteine level…
- Trial name
- NCT01766310
- Testing
- Folic Acid
- Where
- 2 sites in Thailand
- Volunteers
- 50 people
- Sponsor
- Queen Sirikit National Institute of Child Health
Total Parenteral Nutrition-induced Cholestasis
Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is effective in treating parenteral nutrition associated…
- Trial name
- NCT01845116
- Testing
- Omegaven®
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Wake Forest University Health Sciences
Short Bowel Syndrome
Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.
- Trial name
- NCT00930644
- Testing
- teduglutide
- Where
- 23 sites in United States, Canada and 7 more
- Volunteers
- 88 people
- Sponsor
- Shire
Short Bowel Syndrome
Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support
The purpose of this study is to determine if an investigational treatment (teduglutide) is safe and effective in Japanese children (age 4 months through 15 years of age) with SBS who are dependent on parenteral support.
- Trial name
- NCT02980666
- Testing
- Teduglutide
- Where
- 5 sites in Japan
- Volunteers
- 10 people
- Sponsor
- Shire
Celiac Disease
A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet
The main aim is to see how TAK-062 works to reduce celiac-related symptoms and improve small intestinal damage due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in…
- Trial name
- NCT05353985
- Testing
- TAK-062, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar
- Where
- 102 sites in United States, Belgium and 6 more
- Volunteers
- 153 people
- Sponsor
- Takeda
Primary Bile Acid Malabsorption, Secondary Bile Acid Malabsorption
Obeticholic Acid in Bile Acid Diarrhoea
The investigators propose to develop studies of obeticholic acid (OCA) in patients with bile acid diarrhoea. OCA is a semisynthetic bile acid, also known as 6αethylchenodeoxycholic acid or INT747,and is a potent farnesoid X…
- Conditions
- Primary Bile Acid Malabsorption, Secondary Bile Acid Malabsorption, Chronic Diarrhoea
- Trial name
- OBADIAH1 (NCT01585025)
- Testing
- Obeticholic acid
- Where
- 2 sites in United Kingdom
- Volunteers
- 35 people
- Sponsor
- Imperial College Healthcare NHS Trust
Chronic Diarrhea, Irritable Bowel Syndrome With Diarrhea
Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption
To compare with a randomized trial (n=15 per treatment group), effects of colesevelam and placebo treatment, on colonic transit, bowel functions, permeability and tight junction expression in rectosigmoid mucosa of IBS-D with…
- Conditions
- Chronic Diarrhea, Irritable Bowel Syndrome With Diarrhea, Bile Acid Malabsorption
- Trial name
- NCT03270085
- Testing
- Colesevelam
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Mayo Clinic
Gastrointestinal Inflammation Associated With CVID, CVID Enteropathy
Study of Safety, Tolerability, and Efficacy of Ustekinumab for Symptomatic Gastrointestinal Inflammation Associated With Common Variable Immunodeficiency
Background: Some people with Common Variable Immunodeficiency Disease (CVID) have gastrointestinal inflammation. This can cause diarrhea, weight loss, and not being able to absorb nutrition from food.
- Trial name
- NCT02199496
- Testing
- Stelara (ustekinumab)
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Short Bowel Syndrome
Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)
This study will follow participants who completed the TED-C14-006 study. The purpose of this study is to evaluate the long-term safety and efficacy of teduglutide in pediatric participants with Short Bowel Syndrome (SBS).
- Trial name
- NCT02954458
- Testing
- TED, SOC, Syringe
- Where
- 22 sites in United States, Belgium and 4 more
- Volunteers
- 61 people
- Sponsor
- Shire
Short Bowel Syndrome
Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS)
Treatment for 3.5-8 weeks with GH (0.05 mg/kg/day) +GLN+Diet, followed by continued compliance to the individualized oral diet and enteral GLN, will result in reduced volume of TPN infusion/week and/or reduced frequency of TPN…
- Trial name
- NCT00742157
- Testing
- Growth Hormone
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of Nebraska
Cystic Fibrosis, Pancreatic Insufficiency
Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF)
Multicenter, explorative, phase IIIb, open-label study to assess the efficacy and safety of Ultrase® MT12, in the control of steatorrhea and clinical signs and symptoms of malabsorption in CF children with pancreatic…
- Trial name
- NCT00880100
- Testing
- Ultrase® MT12
- Where
- 15 sites in United States
- Volunteers
- 49 people
- Sponsor
- Forest Laboratories
Vitamin D Deficiency, Gastrointestinal Diseases
Ultraviolet Light And Vitamin D In Subjects With Fat Malabsorption Or After Gastric Bypass Surgery
Patients with fat malabsorption due to Crohn's disease, ulcerative colitis, or other causes including cystic fibrosis, among others, or who have undergone gastric bypass have increased incidence of vitamin D deficiency relative…
- Trial name
- NCT01910792
- Testing
- Sperti Lamp
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Boston University
Irritable Bowel Syndrome, Diarrhea
Does Welchol (Colesevelam Hydrochloride) Improve Colonic Transit in Diarrhea-predominant Irritable Bowel Syndrome (D-IBS)?
Our hypothesis is that the medication approved for treatment of high blood cholesterol levels, Colesevelam HCl (WELCHOL), decreases colonic transit and permeability in patients with diarrhea due to irritable bowel syndrome.
- Trial name
- welchol (NCT00911612)
- Testing
- Colesevelam
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Mayo Clinic
Short Bowel Syndrome
Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC)
The primary objective of the trial is to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC.
- Trial name
- STARSnutrition (NCT04964986)
- Testing
- Apraglutide
- Where
- 2 sites in Belgium, France
- Volunteers
- 10 people
- Sponsor
- VectivBio AG
Short Bowel Syndrome
A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021
This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.
- Trial name
- STEPS3 (NCT01560403)
- Testing
- Teduglutide
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Shire
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD).
- Trial name
- NCT02476994
- Testing
- Clinolipid, Intralipid
- Where
- 4 sites in United States
- Volunteers
- 1 people
- Sponsor
- Baxter Healthcare Corporation