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Trial registered on ANZCTR


Registration number
ACTRN12615000596505
Ethics application status
Approved
Date submitted
6/05/2015
Date registered
9/06/2015
Date last updated
10/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
An assessment of the transit times of various liquids and neutraceuticals through the various compartments of the gut using a SmartPill, Registered Trademark.
Scientific title
Assessment of the effect of intestinal permeability probes (lactulose and mannitol) and other liquids on digesta residence times in various segments of the gut determined by wireless motility capsule in healthy female subjects.
Secondary ID [1] 286653 0
None
Universal Trial Number (UTN)
Trial acronym
SmartPill trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The project will determine residence times of digesta in healthy female subjects who have been screened by a medical questionnaire. 294985 0
Condition category
Condition code
Oral and Gastrointestinal 295250 295250 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 291797 0
Other interventions
Comparator / control treatment
100 ml of water
Control group
Placebo

Outcomes
Primary outcome [1] 294998 0
To assess gastric, small intestinal and large intestinal transit time. This is a composite primary outcome.
This will be based on the pH and pressure recordings detremined by the wireless motility capsule, the SmartPill during its passage through the GI tract.
Timepoint [1] 294998 0
The recording for each participant, following the ingestion of each drink, will continue until they have voided the capsule. The sensor on the wireless motility capsule records pH every 5 seconds while the pressure is recorded every half second.
Secondary outcome [1] 314551 0
To assess cyclic variation in the gastric pressure recording extracted from the MotiliGI software (Given Imaging Corp).
Timepoint [1] 314551 0
The recording for each participant, following the ingestion of each drink, will continue until they have voided the capsule. The sensor on the wireless motility capsule records pressure every half second.

Eligibility
Key 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.
Minimum age
20 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.Ssubjects were screened using a health screening questionnaire to exclude those with a personal or strong family history of chronic gastrointestinal (GI) disorders or recent abdominal pain, nausea, vomiting, diarrhea, passage of blood and mucus in stools. Similarly subjects with dysphagia, gastric bezoars, strictures, fistulas, bowel obstructions, diverticulitis, or previous GI surgery(29) were excluded. Subjects with an implanted electromechanical medical device, smokers, those with an intake of alcohol in excess of one standard drink per day, those with aspirin sensitivity and those taking regular prescription or over the counter medications (OTC) were also excluded. In particular those subjects who consumed drugs that were likely to influence GI transit time. Similarly, those consuming vitamins, prebiotics or probiotic supplements such as lactulose were also excluded. All participants were reviewed by a clinician to validate their medical history and responses to the questions before admission to the study. Each participant received each of the five treatments in a randomized sequence at weekly intervals. The order of the treatments was randomized based on a computer generated sequence and was blinded to the subjects.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by a computer software (www.randomization.com)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study; there is no data available regarding variation of gastric motility and residence time utilizing the SmartPill with the above mentioned treatments. Hence data reporting variance between normal healthy subjects which could provide a meaningful test of statistical power are not currently available.
However previous workers have utilised similar sample size and obtained statistically significant results (Dig Dis Sci (2009) 54:2167-2174; BJN (2010) 105:1337-1342).

The effects of the various solutions on segmental transit times and on intra luminal pH will be compared by doubly repeat measure ANOVA. The dominant frequencies of cyclic variation in gastric pressure recordings will be determined by fast Fourier transforms.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2012
Actual
19/10/2012
Date of last participant enrolment
Anticipated
28/02/2013
Actual
4/02/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
6
Recruitment outside Australia
Country [1] 6862 0
New Zealand
State/province [1] 6862 0
Palmerston North

Funding & Sponsors
Funding source category [1] 291231 0
Government body
Name [1] 291231 0
The Ministry of Science and Innovation, New Zealand
Country [1] 291231 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
The New Zealand Institute for Plant & Food Research Limited.
Address
The New Zealand Institute for Plant & Food Research Limited, Private Bag 92169, Auckland Mail Centre, Auckland 1142, New Zealand
Country
New Zealand
Secondary sponsor category [1] 289907 0
None
Name [1] 289907 0
Address [1] 289907 0
Country [1] 289907 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292790 0
Massey University Human Ethics Committee: Southern A
Ethics committee address [1] 292790 0
Ethics committee country [1] 292790 0
New Zealand
Date submitted for ethics approval [1] 292790 0
26/07/2012
Approval date [1] 292790 0
07/09/2012
Ethics approval number [1] 292790 0
12/42.

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 440 440 0 0
/AnzctrAttachments/368497-Instruction sheet.pdf
Attachments [2] 441 441 0 0
/AnzctrAttachments/368497-CARD.pdf
Attachments [3] 442 442 0 0
/AnzctrAttachments/368497-Food avoidance list.pdf
Attachments [4] 443 443 0 0
/AnzctrAttachments/368497-General guidelines and SOP for use of SmartPill Receiver.pdf
Attachments [5] 444 444 0 0
/AnzctrAttachments/368497-Information sheet.pdf
Attachments [6] 446 446 0 0
/AnzctrAttachments/368497-SOP Collection of Faecal Samples.pdf

Contacts
Principal investigator
Name 57046 0
Dr Roger Graham Lentle
Address 57046 0
Institute of Food, Nutrition and Human Health, Massey University, Tennent Drive, Palmerston North 4442, New Zealand.
Country 57046 0
New Zealand
Phone 57046 0
+64 6 350 81402.
Fax 57046 0
+64 6 350 5657
Email 57046 0
R.G.Lentle@massey.ac.nz
Contact person for public queries
Name 57047 0
Ivana Roosevelt Sequeira
Address 57047 0
Institute of Food, Nutrition and Human Health, Massey University, Tennent Drive, Palmerston North 4442, New Zealand.
Country 57047 0
New Zealand
Phone 57047 0
+64 6 350 83367
Fax 57047 0
+64 6 350 5657
Email 57047 0
I.R.Sequeira@massey.ac.nz
Contact person for scientific queries
Name 57048 0
Roger Graham Lentle
Address 57048 0
Institute of Food, Nutrition and Human Health, Massey University, Tennent Drive, Palmerston North 4442, New Zealand
Country 57048 0
New Zealand
Phone 57048 0
+64 6 350 81402.
Fax 57048 0
+64 (0)6 350 5657
Email 57048 0
R.G.Lentle@massey.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAssessment of the Effect of Intestinal Permeability Probes (Lactulose and Mannitol) and Other Liquids on Digesta Residence Times in Various Segments of the Gut Determined by Wireless Motility Capsule: A Randomised Controlled Trial.2015https://dx.doi.org/10.1371/journal.pone.0143690
N.B. These documents automatically identified may not have been verified by the study sponsor.