Gastrointestinal Dysfunction
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled, 3 arm parallel group study of 12 weeks duration, with a 4-week run-in period as the control phase and an 8-week intervention period, to investigate the effectiveness of the treatment on upper GI disturbance.
Interventions
DRUGHigh Dose Maolactin
Once daily dose of 2 capsules (2 capsules containing 250mg active proteins per capsule; equivalent to 500mg active proteins per day)
DRUGLow Dose Maolactin
Once daily dose of 2 capsules (1 capsule containing 250mg active proteins per capsule and 1 capsule containing maltodextrin only; equivalent to 250mg active proteins per day)
DRUGMaltodextrin
Once daily dose of 2 capsules
Sponsors
Maolac
RDC Clinical Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 a week for at least 3 months. * Normal dietary habits (no FODMAP diet, elimination diet, vegan diet, etc) with a minimum 2-month period of self-reported dietary stability. * Agree to not change current diet and/or exercise frequency or intensity during entire study period * Agree to not use any dietary supplements for gut health or digestive enzymes during the study period
Exclusion criteria
* Unstable(1) or serious illness (e.g. serious mood disorders such as depression or bipolar 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 bowel disease, celiac disease or cystic fibrosis as well as gastrointestinal tract surgery * Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for malignancy 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 participant unsuitable 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in upper gastrointestinal symptoms | Day -28, Day 0, Day 14, Day 28, Day 56 | Change in upper gastrointestinal symptoms as measured by Gastrointestinal Symptom Rating Scale (GSRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in safety | Day 0, Day 56 | Change in safety as measured by E/LFT via including cholesterol and glucose via blood sample |
| Change in upper gastrointestinal symptoms | Day -28, Day 0, Day 14, Day 28, Day 56 | Change in upper gastrointestinal symptoms as measured by Gastroesophageal Reflux Disease Questionnaire (GerdQ) |
| Change in gut microbiome | Day 0, Day 56 | Change in gut microbiome as measured by stool sample analysis |
| Change in stool frequency and consistency | Day -28, Day 0, Day 14, Day 28, Day 56 | Change in stool frequency and consistency as measured by Bristol Stool Chart |
| Change in inflammatory markers | Day 0, Day 56 | Change in inflammation as measured by inflammatory markers (TNFα, interleukin (IL)-1β, IL-6, and IL-8, CRP, Nf-Kb) via blood test |
| Change in gut inflammation | Day 0, Day 56 | Change in gut inflammation as measured by faecal calprotectin via stool sample |
| Change in quality of life | Day -28, Day 0, Day 14, Day 28, Day 56 | Change in quality of life as measured by Digestion-associated Quality of Life Questionnaire (DQLQ) |
| Change in diet | Days -27, -26, -25, Days -3, -2, -1, Days 25, 26, 27, Days 53, 54, 55 | Change in diet as measured by 24-hour Dietary Recall |
| Change in intestinal permeability | Day 0, Day 56 | Change in intestinal permeability as measured by Plasma Zonulin via blood sample |
Countries
Australia
Outcome results
None listed