Study Design Type:
Prospective single-blinded intervention feasibility study
Methodology/Study Design:
A cohort of IBD patients and their healthy household controls will be recruited for this
study. You will be instructed to use a handheld breathalyzer device, AIRE-2, to measure
exhaled H2 and CH4 gas production, and its smartphone app, FoodMarble, will be used to
log your diet and symptoms for a period of 5 weeks, as follows:
AIRE-2 will be used before and after two meals each day - the first meal and the last
meal of the day. You will breathe into the AIRE-2 device before eating to obtain the
baseline value. After the meal, you will breathe into the AIRE-2 60 minutes
postprandially. The exhaled H2 and CH4 measurements will be automatically logged into the
FoodMarble app, which is connected via Bluetooth. You will log your food intake and
symptoms in FoodMarble. Symptoms scores will be recorded at the same time that the AIRE-
2 device is being used - 60 minutes postprandial. You will be asked not to drink alcohol
during the meals that will be recorded, as this will skew the device results. You will be
informed that you can consume alcoholic drinks after doing the postprandial breath test.
Study procedure:
Study Enrolment and Familiarization Period: At visit 1, you will be trained to use
the AIRE-2 device which McMaster has purchased from the FoodMarble company and will
be provided to you. You will also be trained to use the FoodMarble app. The
FoodMarble company is the owner of the AIRE-2 device which is being used in the
present study, the company wouldn't have access to resulting data other than
publication. Demographics, medical history, disease activity, Gastrointestinal
symptom rating scale (GSRS), Bristol stool type, medications, supplements, perceived
food intolerances and general dietary patterns will be recorded at baseline. We
shall assist you in inputting some GI and extra-intestinal symptoms (headache, foggy
mind, numbness of joints, joint pain, fainting, oral lesions, dermatitis) manually
in the FoodMarble app from the GSRS symptom questionnaire as all symptoms are not
mentioned in the app and there is a provision to edit the symptom list. After visit
1, you will have 3 days to use the device and app in order to become familiar with
its use and report any challenges and difficulties to us in visit 2 (online via
McMaster Zoom). At the end of the familiarization period, you are expected to be
comfortable using the AIRE-2 device and the FoodMarble app. No data reported during
this period will be used for the purpose of analysis or outcomes evaluation.
Baseline Period: This period starts after the familiarization week and runs for one
week, representing the beginning of the data tracking collection. During the
baseline period, you will eat your normal, typical diet, while collecting your
breath test, food and symptoms as described above. The baseline period serves to
capture the natural fluctuations of breath H2 and CH4 of each individual and to
explore the correlations with diet and symptoms. You will be instructed to take the
breath test before and 60 minutes after two major meals, every day. You will also
collect the baseline stool sample and drop it off at the study location during visit
3, at the end of this period. You will be handed the low FODMAP diet chart which
will be required in discovery period.
Discovery Period: This period starts after the baseline period and runs for four
weeks. During this period, you will document your responses to challenges with four
specific FCHOs)- Lactose, Fructose, Sorbitol, and Inulin ("Food Intolerance Kit",
FoodMarble Inc, Dublin, Ireland). The quantities of each FCHO challenge are as
follows: lactose and fructose sachets, 25g each. A sachet of lactose roughly equal
to amount of lactose present in 1 large glass of milk. A sachet of fructose is
roughly equal to amount of fructose present in 2 large apples. Sorbitol and inulin
sachets contain 10g each. A sachet of sorbitol is roughly equal to the amount of
sorbitol present in 3 pears or 1 prune. A sachet of inulin is roughly equal to the
amount of inulin present in 1 head of garlic. Each sachet has to be dissolved in 250
ml of lukewarm water. Before each challenge, you will follow a low FODMAP diet for
24h to facilitate clearance of any FCHOs from the intestine. You will be guided by a
registered dietitian (RD) regarding an appropriate low FCHO diet, supported by the
FoodMarble app, which provides a large database of low FODMAP meals and recipes. You
will log all meals during the 24h low FCHO period using the FoodMarble app. The
meals will be analyzed by the RD and scored, on a 4-point scale (poor, moderate,
good, excellent) for adherence to the low FCHO diet. Exhaled H2 and CH4 will be
measured before and 60 min after the first and last meal during this period, as
usual. After the 24h low FCHO diet, you will consume one FCHO challenge in the
morning (after the baseline breath test) and take the postprandial breath test 60
min later. You will be required to record the breath test for 3 hours after every 15
minutes as per the protocol of the kit. You will then collect the first stool sample
after the challenge and submit it to us in visit 4. Symptoms and meals will continue
to be logged in the FoodMarble app. You will also be instructed to fill in a
validated questionnaire to assess symptoms before and after the FCHO challenge
(Adult Carbohydrate Perception Questionnaire). This questionnaire will be given to
you in paper form. A 6-day washout period will be implemented in between the FCHO
challenges. During the washout period, you will follow your typical diet. The 24h
low Fodmap day, FCHO challenge, 6-day washout cycle and submission of stool samples
(visit 4-7) will be repeated until all 4 FCHO challenges have been completed. The
order of the FCHO challenges will be randomized and will be kept constant between
all of you to minimize potential co-founding factors related to the order of the
intervention. However, you will be blinded to the order.
End of the study: At the end of the discovery period, you will answer a feedback
survey to report their experience using AIRE-2 and FoodMarble.