Assessment of Gastric Emptying Speed in Patients Who Experience Diarrhea Following a Trigger Meal
Pilot Study: Assessment of Gastric and Intestinal Motility Following a Trigger Meal in Patients With Post Prandial Diarrhea
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
Typ studie
Typ studie
Fáze
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- The patient must have been diagnosed as having post prandial diarrhea for at least 5 years by his/her primary care physician or gastroenterologist and is believed to have no other medical condition that would cause this medical problem. Each person must be over 18 years old and have negative testing for Celiac Disease, a normal colonoscopy within 5 years of enrollment, and a normal Hgb and sedimentation rate within 6 months of enrollment in the trial.
- The patient has provided documented written informed consent/authorization prior to initiation of any study-related procedure.
- In addition, each patient must report experiencing the onset of urgent defecation within 1 hours of eating a specific trigger which is reproducible at least 90% of the time when consume.
- The patient must be willing to comply with all of the study protocol.
Exclusion Criteria:
- The patient has had any rectal bleeding or bloody stools within the last 2 years not completely evaluated by a physician. If rectal bleeding has occurred, and the patient wants to be considered for the study, the diagnostic workup must have clearly identified the etiology for the bleeding and excluded the medical conditions listed under 3 below. The patient must be willing to allow the Study team to obtain these records for verification of the diagnosis.
- The patient has nocturnal bowel movements.
- The patient has been diagnosed with or has a family history of any of the following: ulcerative colitis, Crohn's Disease, celiac disease, sprue, other inflammatory bowel disease or has a positive test for celiac disease on screening lab and has not had a full investigation performed to exclude celiac disease.
- The patient has had unexplained anorexia or weight loss of more than 10% of body weight within 12 months of onset of study.
- Prior GI surgery except of uncomplicated appendectomy and laparoscopic cholecystectomy or history of bowel obstruction or symptoms suggestive of such within the past 2 years.
- The patient reports daily use of laxatives or stool softeners; use of fiber supplementation is permitted.
- The patient is currently using pancrealipase. Previous use of pancrealipase in the past is allowed, but patients must be off either of the medication for at least 1 week or until the patient's symptoms of post prandial diarrhea returns before participating in the study.
- Use of implanted or ambulatory electromechanical medical devices such as pacemakers, insulin pumps, and infusion pumps.
- History of gastroparesis or chronic use of reglan.
- Dysphagia to solid food and pills.
- Previous gastro-esophageal surgery including vagotomy, fundoplication, gastric bypass or ulcer surgery.
- Tobacco use within eight hours prior to capsule ingestion and during the 8 hour monitoring time.
- Alcohol use within 24 hours prior to capsule ingestion and throughout the entire monitoring period (up to 72 hours).
- BMI > 35
- Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Nerandomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Aktivní komparátor: non-trigger meal
Measurement of intestinal transport eating a "non-trigger meal".
|
Measurement of a baseline, non-trigger meal intestinal transit by using the SmartPill capsule.
Measurement of intestinal transit of a "trigger meal" baseline by using the SmartPill capsule
SmartPill capsule
|
|
Aktivní komparátor: "trigger meal baseline"
Measurement of intestinal transport after eating a "trigger meal".
|
Measurement of a baseline, non-trigger meal intestinal transit by using the SmartPill capsule.
Measurement of intestinal transit of a "trigger meal" baseline by using the SmartPill capsule
SmartPill capsule
|
|
Komparátor placeba: "trigger meal" with placebo
Measurement of intestinal transport with blinded placebo
|
Measurement of a baseline, non-trigger meal intestinal transit by using the SmartPill capsule.
Measurement of intestinal transit of a "trigger meal" baseline by using the SmartPill capsule
SmartPill capsule
ZenPep 20000 units of lipase will be provided for the participant to take with a trigger meal or an identical placebo.
This will only be given to those participants willing to consume 2 more identical "trigger meals" and will not be given for the initial baseline "non-trigger" and baseline "trigger meal".
In both of these arms, patients will also be swallowing the SmartPill Capsule.
|
|
Aktivní komparátor: "trigger meal" with enzymes (blinded)
Measurement of intestinal transport with blinded active enzyme capsule
|
Measurement of a baseline, non-trigger meal intestinal transit by using the SmartPill capsule.
Measurement of intestinal transit of a "trigger meal" baseline by using the SmartPill capsule
SmartPill capsule
ZenPep 20000 units of lipase will be provided for the participant to take with a trigger meal or an identical placebo.
This will only be given to those participants willing to consume 2 more identical "trigger meals" and will not be given for the initial baseline "non-trigger" and baseline "trigger meal".
In both of these arms, patients will also be swallowing the SmartPill Capsule.
|
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Duration of intestinal speed of a "trigger meal" compared to a non-trigger meal baseline. Optional study comparing intestinal speed of trigger meal using Pancrelipase compared to placebo.
Časové okno: 72 hour measurement per meal
|
Data from the SmartPill radiofrequency capsule that is swallowed at the beginning of the different meals will be recorded and compared.
|
72 hour measurement per meal
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Mary E Money, M.D., Washington County Hospital
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- 2010IBS-G/D eval
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