Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 65 Years|
Inclusion Criteria:- Healthy subjects - Celiac disease and wheat allergy excluded by antigen test - Age 18-65 - BMI 18,5 - 30 - Normal liver, thyroid and kidney functions
Exclusion Criteria:- Pacemaker or other implanted electronical device - Crohn's disease, ulcerative colitis or acute diverticulitis - Dysphagia or difficulties with swallowing - Surgery on the GI tract within the last 3 months - Intestinal obstruction - Gastric bezoar - Severe constipation - Medication that majorly affects GI tract (e.g. laxatives, antacids) - Antibiotic treatment within the last 6 months - Blood donation or participating in a another clinical trial within the last month
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Turku|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Kaisa Linderborg, PhD|
|Principal Investigator Affiliation||Associate professor|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption|
Part 1 will be conducted as a double-blind, randomized and placebo-controlled cross-over study. Healthy subjects will be recruited to the study. The aim is to recruit 15 participants for the part 1. The study will be conducted with a cross-over setting, where the subjects will go through exposure meals and SmartPill ingestion three times (three different oat products) in a randomized order. The study meals are identical in appearance and fiber content. After consuming the meal subjects will ingest the SmartPill capsule, which will send data on intestinal pH, pressure and temperature to the external portable device. Before and during the passage of capsule the subjects will fill a symptom and food diary. The capsule will exit the body in 1 to 3 days and the data collected by the external device will be collected and analyzed. Before the oat exposure the subjects will give a fecal and a blood sample. In addition, 24 hours urine samples will be collected.
Experimental: Oat meal 1
A single gluten-free oat containing meal number 1 before ingesting the SmartPill capsule. Dietary intervention. Gluten free oats and gastrointestinal health
Placebo Comparator: Placebo meal
A single meal which does not contain oats before ingesting the SmartPill capsule. Dietary intervention: gluten-free oats and gastrointestinal health.
Experimental: Oat meal 2
A single gluten-free oat containing meal number 2 before ingesting the SmartPill capsule. Dietary intervention. Gluten free oats and gastrointestinal health
Other: - Gluten free oats and gastrointestinal health
Subjects will be served 3 different test meals in a randomized order in the cross-over design
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.