Phase
Condition
Bowel Dysfunction
Treatment
Maltodextrin
High Dose Maolactin
Low Dose Maolactin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults 18 years and over
Generally healthy
BMI <35kg/m2
Able to provide informed consent
Agree to not participate in another clinical trial while enrolled in this trial
Females using a prescribed form of birth control (e.g. oral contraceptive)
Experiencing moderate GI disturbances of the upper GI tract - 1 or multiple symptoms (reflux, heartburn, regurgitation, nausea, bloating, abdominal pain) at least once aweek for at least 3 months.
Normal dietary habits (no FODMAP diet, elimination diet, vegan diet, etc) with aminimum 2-month period of self-reported dietary stability.
Agree to not change current diet and/or exercise frequency or intensity duringentire study period
Agree to not use any dietary supplements for gut health or digestive enzymes duringthe study period
Exclusion
Exclusion Criteria:
Unstable(1) or serious illness (e.g. serious mood disorders such as depression orbipolar disorder, neurological disorders such as MS, kidney disease, liver disease,heart conditions, diabetes, thyroid gland dysfunction)
People with a past or current history of GIT conditions e.g. inflammatory boweldisease, celiac disease or cystic fibrosis as well as gastrointestinal tract surgery
Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment formalignancy within the previous 2 years
Currently taking any proton pump inhibitors [e.g., pantoprazole (Somac), rabeprazole (Pariet), omeprazole (Losec) or any anticoagulation or antiplatelet medications [e.g. Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin, dabigatran (Pradaxa),rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa), betrixaban (Bevyxxa),clopidogrel (Plavix), prasugrel (Effient), ticagrelor (Brilinta), cilostazol (Pletal) and dipyridamole (Attia, Ofcram, Persantin, Persantin Retard, Trolactin)]including low dose aspirin (acetylsalicylic acid)
Active smokers, nicotine use or drug (prescription or illegal substances) abuse
Allergic to any of the ingredients in active or placebo formula
Pregnant or lactating woman or women trying to conceive
Any condition which in the opinion of the investigator makes the participantunsuitable for inclusion (including hypercholesterolemia)
Currently participating in any other clinical trial
Footnote
(1)An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
Study Design
Connect with a study center
RDC Clinical Pty Ltd
Brisbane, Queensland 4006
AustraliaActive - Recruiting
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