Effect of Maolactin on gastrointestinal health
Effect of MaolactinTM Supplement on Gastrointestinal Tract (GIT) Health in Adult Subjects: a Double-blind Randomized Placebo-controlled Study
This study is testing if a new supplement called Maolactin can help adults with moderate gastrointestinal issues like reflux, heartburn, and nausea feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RDC Clinical Pty Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Brisbane, Queensland) |
| Trial ID | NCT06104917 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effectiveness of Maolactin on gastrointestinal health. The study involves three groups: one receiving a high dose of Maolactin, another receiving a low dose, and a control group receiving maltodextrin. Participants will undergo a 12-week intervention period following a 4-week run-in phase to assess their upper gastrointestinal disturbances. The trial aims to determine if Maolactin can alleviate symptoms such as reflux, heartburn, and nausea in adults experiencing moderate GI disturbances.
Who should consider this trial
Good fit: Ideal candidates are generally healthy adults aged 18 and over who experience moderate upper GI disturbances at least once a week for the past three months.
Not a fit: Patients with serious or unstable illnesses, such as severe mood disorders or neurological disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve gastrointestinal health and quality of life for patients suffering from upper GI disturbances.
How similar studies have performed: While this specific approach may be novel, similar studies investigating dietary interventions for gastrointestinal health have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Brisbane, Queensland
- RDC Clinical Pty Ltd — Brisbane, Queensland, Australia (Recruiting)
Study contacts
- Study coordinator: Amanda Rao, PhD
- Email: amanda@rdcglobal.com.au
- Phone: +61 414 488 559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.