Effect of Maolactin on Gastrointestinal Tract (GIT) Health
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High Dose Maolactin Maolactin 250mg capsule - Take 2 capsules once daily before the morning meal. |
Drug: High Dose Maolactin
Once daily dose of 2 capsules (250mg per capsule)
|
| Experimental: Low Dose Maolactin Maolactin 125mg capsule - Take 2 capsules once daily before the morning meal. |
Drug: Low Dose Maolactin
Once daily dose of 2 capsules (125mg per capsule)
|
| Placebo Comparator: Maltodextrin Placebo capsule - Take 2 capsules once daily before the morning meal. |
Drug: Maltodextrin
Once daily dose of 2 capsules
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 upper gastrointestinal symptoms [Day -28, Day 0, Day 14, Day 28, Day 56]
Change in upper gastrointestinal symptoms as measured by Bloating Symptoms VAS (BSVAS)
- 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 intestinal permeability [Day 0, Day 56]
Change in intestinal permeability as measured by Plasma Zonulin via blood sample
- Change in intestinal permeability [Day 0, Day 56]
Change in intestinal permeability as measured by 6 hour urine 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 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 safety [Day 0, Day 56]
Change in safety as measured by E/LFT via including cholesterol and glucose via blood sample
- Change in safety [Day -28 to Day 56]
Change in safety as measured by adverse events
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- RDC Clinical Pty Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MAOGIT