Clinical trials: Feeding
Exocrine Pancreatic Insufficiency
Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)
Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis.
- Trial name
- NCT02598128
- Testing
- RELiZORB
- Where
- 11 sites in United States
- Volunteers
- 34 people
- Sponsor
- Alcresta Therapeutics, Inc.
Norovirus Infections
A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants
The primary objective of this study is to evaluate the safety and tolerability of an oral bivalent GI.1/GII.4 norovirus vaccine administration in healthy lactating female participants and to assess the short-term immunogenicity…
- Trial name
- NCT07254728
- Testing
- VXA-G1.1-NN, VXA-G2.4-NS
- Where
- 5 sites in South Africa
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Vaxart
Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use
Food and Insulin Effect on QT/QTC Interval of ECG
Moxifloxacin is routinely used as a probe to confirm assay sensitivity in thorough electrocardiogram (ECG) studies. It has been shown that a meal shortens the QT interval, which may affect pharmacokinetics (PK) and/or…
- Conditions
- Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use, C-Peptide Effects on the QT/QTc Interval, Moxifloxacin ECG Profile in Fed and Fasted State
- Trial name
- C11035 (NCT01642485)
- Testing
- Moxifloxacin 400 mg fasted, FDA breakfast, Continental breakfast
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Richmond Pharmacology Limited
Colitis, Ulcerative, Crohn's Disease
Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease
The purpose of this study is to assess the concentration of vedolizumab in breast milk of lactating women with active ulcerative colitis (UC) or Crohn's disease (CD) who are receiving vedolizumab therapeutically.
- Trial name
- NCT02559713
- Testing
- Vedolizumab
- Where
- 7 sites in United States
- Volunteers
- 11 people
- Sponsor
- Takeda
Covid-19 Testing
Study Utilizing BIOZEK COVID-19 Antigen Rapid Test
This is a research study to evaluate the Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test (Saliva) and BIOZEK COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) on samples that are self-collected; and to perform…
- Trial name
- NCT04926779
- Testing
- Biozek Covid-19 Antigen Rapid Test (Saliva)
- Where
- 2 sites in United States
- Volunteers
- 185 people
- Sponsor
- Mach-E B.V.
Intrauterine Devices
Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs
Study to analyze electronic medical records of women using an intrauterine device (IUD). The study was required by the FDA for the marketed IUD Mirena (US Post-marketing requirement; short name of study: APEX IUD).
- Trial name
- APEX IUD (NCT03754556)
- Testing
- Intrauterine device
- Where
- 4 sites in United States
- Volunteers
- 326,658 people, healthy volunteers welcome
- Sponsor
- Bayer
Aspiration Pneumonia, Malnutrition
Nutrition Monitoring and Feeding Optimization With the smART+ System - Comparative Study
The smART+ is a comprehensive modular patient care system intended for ICU patients. The main purpose of the study is the optimization of the delivery of nutrition.
- Trial name
- NCT04098224
- Testing
- smART+ System
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- ART Medical Ltd.
Binge Eating Disorder
SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
The primary objective of the study is to demonstrate the efficacy of SPD489 compared with placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating Disorder at Visit 8 (Weeks 11 and 12) as measured by…
- Trial name
- NCT01718509
- Testing
- SPD489 (Lisdexamfetamine dimesylate)
- Where
- 48 sites in United States, Germany
- Volunteers
- 390 people
- Sponsor
- Shire
Binge Eating Disorder
SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
The primary objective of the study is to demonstrate the efficacy of SPD489 compared with placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating Disorder at Visit 8 (Weeks 11 and 12) as measured by…
- Trial name
- NCT01718483
- Testing
- SPD489 (Lisdexamfetamine dimesylate)
- Where
- 50 sites in United States, Germany and 2 more
- Volunteers
- 383 people
- Sponsor
- Shire
Hemostasis, Perforation Colon
MANTIS Endoscopic Clipping Study
This study is intended to document procedural and clinical effectiveness in consecutive cases in which at least one MANTIS clip is selected, pertaining to use of a new endoscopic clipping device MANTIS™ including but not limited…
- Conditions
- Hemostasis, Perforation Colon, Feeding Tube Complication, Endoscopy
- Trial name
- NCT05653843
- Testing
- Endoscopic clip placement in the gastrointestinal tract.
- Where
- 10 sites in United States, Canada and 4 more
- Volunteers
- 240 people
- Sponsor
- Boston Scientific Corporation
Binge Eating Disorder
Open Label Extension in Adults With Binge Eating Disorder (BED)
To evaluate the safety and tolerability of SPD489 administered as a daily morning dose (50 or 70mg) in the treatment of moderate to severe binge eating disorder (BED) in adults
- Trial name
- NCT01657019
- Testing
- Lisdexamfetamine dimesylate
- Where
- 89 sites in United States, Germany and 1 more
- Volunteers
- 604 people
- Sponsor
- Shire
Enteral Nutrition
Feasibility Study to Evaluate Safety of ENvizion Medical™ ENVUE™ System
This is a single center, non-randomized feasibility clinical evaluation that is designed to affirm the safety of the ENVUE™ System guidance during the placement of the ENvizion Medical™ enteral feeding tubes.
- Trial name
- NCT03505593
- Testing
- ENVUE System
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Envizion Medical Ltd.
Healthy
Bioequivalence Study of Fenofibric Acid Versus Tricor® (Fenofibrate)
This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers under fasting conditions.
- Trial name
- NCT00961116
- Testing
- Fenofibric Acid (Fibricor™) 105 mg Tablet, Fenofibrate (Tricor®) 145 mg Tablet
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Binge-Eating Disorder
A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder
The primary objective of this study is to assess the efficacy of 2 doses of centanafadine sustained-release (SR) (200 milligrams [mg] and 400 mg total daily dose [TDD]) compared with placebo in adults with moderate to severe…
- Trial name
- NCT05113953
- Testing
- Centanafadine
- Where
- 25 sites in United States
- Volunteers
- 147 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Cystic Fibrosis
Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study
Protocol 0000498: Multicenter, open label study to evaluate the effect of sustained RELiZORB (immobilized lipase) cartridge use during enteral feeding on fat absorption, as well as safety and tolerability of sustained RELiZORB…
- Trial name
- ASSURE (NCT02750501)
- Testing
- RELiZORB (immobilized lipase) cartridge, Impact Peptide 1.5
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Alcresta Therapeutics, Inc.
Critical Illness, Enteral Nutrition
TAK-954 in Critically Ill Participants With Enteral Feeding Intolerance (EFI)
The purpose of this study is to assess the treatment effect of intravenous TAK-954 in improving the average daily protein adequacy received through enteral nutrition in critically-ill participants developing EFI.
- Conditions
- Critical Illness, Enteral Nutrition, Enteral Feeding Intolerance
- Trial name
- NCT03477903
- Testing
- TAK-954, Metoclopramide, Normal Saline
- Where
- 44 sites in United States, Australia and 2 more
- Volunteers
- 1 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Healthy Lactating Women
A Study Of Pregabalin (Lyrica) Drug Levels In Urine, Plasma And Breast Milk Of Healthy Lactating Women
This is a pharmacokinetic study to determine the safety and tolerability of pregabalin in healthy lactating women. The objectives are to determine whether pregabalin is secreted in breast milk and if so, to characterize…
- Trial name
- NCT01727791
- Testing
- pregabalin (Lyrica)
- Where
- Belgium
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Colic
Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance
The present pilot study is aimed to obtain preliminary data on the effect of three ascending oral dose levels of nepadutant on the relief of symptoms associated with feeding intolerance.
- Trial name
- NCT01532518
- Testing
- Nepadutant
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- Menarini Group
Multiple Sclerosis, Clinically Isolated Syndrome
A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab
This study will evaluate the pharmacokinetics of ocrelizumab in the breastmilk of lactating women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] treated with…
- Trial name
- SOPRANINO (NCT04998851)
- Testing
- Ocrelizumab
- Where
- 8 sites in United States, Spain and 1 more
- Volunteers
- 26 people
- Sponsor
- Hoffmann-La Roche
Nutrition, Healthy, Behavior, Eating
Good Bowls: Eat Well At Work
The goal of this clinical trial is to improve the health of workers at their worksite by providing subsidized healthy meals supported by nutrition education and behavioral nudges using mobile health and Bluetooth technology.
- Trial name
- EWAW (NCT05776303)
- Testing
- Good Bowls, Good Bowls + App Nudges
- Where
- United States
- Volunteers
- 201 people, healthy volunteers welcome
- Sponsor
- Equiti Food, LLC