Effect of Maolactin on Gastrointestinal Tract (GIT) Health

Launched by RDC CLINICAL PTY LTD · Oct 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called Maolactin on gastrointestinal (GI) health, specifically focusing on upper GI disturbances like reflux, heartburn, nausea, and bloating. The study will last for 12 weeks, including a 4-week period where participants will not receive any treatment, followed by 8 weeks of receiving either Maolactin or a placebo (a non-active treatment). This trial is designed to see if Maolactin can help improve symptoms for people experiencing moderate GI issues at least once a week for the last three months.

To be eligible for this trial, participants should be at least 18 years old, generally healthy, and have a body mass index (BMI) of less than 35. They should also have been experiencing specific GI symptoms regularly. It's important that participants do not have a history of serious illnesses or certain GI conditions and are not taking medications that could interfere with the study. Participants can expect to follow their usual diet and lifestyle throughout the trial, and they will need to avoid other dietary supplements or clinical trials during this period. If you or a loved one are experiencing persistent GI issues, this study may provide an opportunity to explore a potential treatment option.

Gender

ALL

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.