None listed
Conditions
Brief summary
To determine mean residence times of digesta in the various segments of the gut when liquid material is given using a wireless motility capsule, the SmartPill.
Interventions
1) The presence of a single dose of aspirin (600mg), vitamin C (500mg), lactulose (10g) mannitol (5g) , berry extract (high osmolality and diverse chemical composition) in a set ingested volume of drink (100 ml of water). Each subject will be randomized to receive each of the five treatments [including a negative control of water (100 ml) only]. The treatments will be delivered in randomized order and administered at 1 week intervals, intervals calculated from the day the SmartPill, Registered T
1) The presence of a single dose of aspirin (600mg), vitamin C (500mg), lactulose (10g) mannitol (5g) , berry extract (high osmolality and diverse chemical composition) in a set ingested volume of drink (100 ml of water). Each subject will be randomized to receive each of the five treatments [including a negative control of water (100 ml) only]. The treatments will be delivered in randomized order and administered at 1 week intervals, intervals calculated from the day the SmartPill, Registered Trademark, is voided. 2) The consumption of the SmartPill (SmartPill Corporation, Buffalo, NY, USA). The use of this wireless motility capsule as a basis for deriving segmental transit times has recently been attested in a position statement of the American and European Neurogastorenterology and Motility Societies (Neurogastroenterol Motil (2011)23:8-23). This is a study to observe transit times in normal subjects and will be deduced from SmartPill data according to changes in pH and ambient intraluminal pressure. The SmartPill will enable us to assess these transit times in ambulant human subjects. The device is in the form of a pill 11.7mm x 26.8mm which is swallowed and continuously monitors and transmits lumen pH, pressure and temperature as it traverses the GI tract. The transmitted data is captured and stored on a data logger which is worn on a belt around the waist. Hence it is possible to determine gastric residence time (rise in pH and change in pressure wave form when the capsule enters the duodenum), the small intestinal residence time (fall in pH and change in motility pattern as capsule enters the colon) and the colonic residence time (fall in temperature as capsule exits the rectum) as well as determine the contractile work and pattern within each segment.The estimated transit time for the SmartPill is over a period of 24 - 120 hours.
Sponsors
The New Zealand Institute for Plant & Food Research Limited.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy female volunteers of 165-170cm; 65-70kg between the age of 20 and 40 years will be screened by questionnaire for general medical health, gut health, ongoing consumption of medication, dietary supplements, dietary peculiarities and smoking. Inclusion criteria is as follows: (1) Participants will be non smokers with no history of gastrointestinal diseases including recent gut infection evidenced by a recent history of abdominal pain, nausea, vomiting, diarrhea, passage of blood and mucus in stools. (2) Participants will be taking no ongoing prescription or OTC medication or multivitamins except for contraceptive pills. (3) Not taking any medications that affect gastrointestinal motility such as pro-kinetics, narcotic analgesics, antispasmodics, or pills to treat diarrhea and constipation. (4) The number of standard alcohol drinks consumed per week will be calculated from results of alcohol consumption in the questionnaire to ensure that participants do not exceed a moderate alcohol intake.
Exclusion criteria
Participants will be screened by a Health Questionnaire to determine participation in the study. Volunteers who will be excluded are those that: (1) Are of small stature (no less than 165-170cm; apprx 65-70 kg), (2) Are smokers or tobacco chewers, (3) Exceed the intake of one standard alcohol drink per day, (4) Have a history of gastrointestinal diseases including recent gut infection evidenced by a recent history of abdominal pain, nausea, vomiting, diarrhea, passage of blood and mucus in stools, (5) Suffer from any inter current gastrointestinal disorder (contraindicated dysphagia, gastric bezoars, strictures, fistulas, bowel obstructions, diverticulitis, previous gastrointestinal surgery) and are likely to retain the capsule in the stomach (as has rarely been reported), (6) Have implanted electromechanical medical devices and medications that influence gastrointestinal transit time, (7) Have an earlier diagnosis of diabetes, cancer, Crohn’s disease, ulcerative colitis, irritable bowel disease, (8) Have undergone abdominal surgery, (9) Have a BMI < 18.5 or > 30kg/m2, (10) Are pregnant or lactating, (11) Have irregular menstrual cycles, (12) Have a high dietary fibre intake or on a vegetarian diet, (13) Have food allergies, (14) Have a history of or current urinary tract infections, vaginal conditions that cause discharge, (15) Have aspirin sensitivity, (16) Take ongoing prescription medication, antibiotics, OTC medication or multivitamins, (17) Take prebiotic and probiotic and fibre supplements such as lactulose.
Outcome results
None listed