Clinical trial NCT06104917: Effect of Maolactin on Gastrointestinal Tract (GIT) Health
Official title: Effect of MaolactinTM Supplement on Gastrointestinal Tract (GIT) Health in Adult Subjects: a Double-blind Randomized Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gastrointestinal Dysfunction
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2023-10-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in upper gastrointestinal symptoms
timeFrame: Day -28, Day 0, Day 14, Day 28, Day 56
Secondary outcomes:
measure: Change in upper gastrointestinal symptoms
timeFrame: Day -28, Day 0, Day 14, Day 28, Day 56
measure: Change in upper gastrointestinal symptoms
timeFrame: Day -28, Day 0, Day 14, Day 28, Day 56
measure: Change in gut microbiome
timeFrame: Day 0, Day 56
measure: Change in stool frequency and consistency
timeFrame: Day -28, Day 0, Day 14, Day 28, Day 56
measure: Change in intestinal permeability
timeFrame: Day 0, Day 56
measure: Change in intestinal permeability
timeFrame: Day 0, Day 56
measure: Change in gut inflammation
timeFrame: Day 0, Day 56
measure: Change in quality of life
timeFrame: Day -28, Day 0, Day 14, Day 28, Day 56
measure: Change in diet
timeFrame: Days -27, -26, -25, Days -3, -2, -1, Days 25, 26, 27, Days 53, 54, 55
measure: Change in inflammatory markers
timeFrame: Day 0, Day 56
measure: Change in safety
timeFrame: Day 0, Day 56
measure: Change in safety
timeFrame: Day -28 to Day 56
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: RDC Clinical Pty Ltd
state: Queensland
Study officials:
References: