Effect of Maolactin on Gastrointestinal Tract (GIT) Health

Last updated: April 1, 2025
Sponsor: RDC Clinical Pty Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

Bowel Dysfunction

Treatment

Maltodextrin

High Dose Maolactin

Low Dose Maolactin

Clinical Study ID

NCT06104917
MAOGIT
  • Ages > 18
  • All Genders

Study 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

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 aweek for at least 3 months.

  • Normal dietary habits (no FODMAP diet, elimination diet, vegan diet, etc) with aminimum 2-month period of self-reported dietary stability.

  • Agree to not change current diet and/or exercise frequency or intensity duringentire study period

  • Agree to not use any dietary supplements for gut health or digestive enzymes duringthe study period

Exclusion

Exclusion Criteria:

  • Unstable(1) or serious illness (e.g. serious mood disorders such as depression orbipolar 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 boweldisease, celiac disease or cystic fibrosis as well as gastrointestinal tract surgery

  • Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment formalignancy 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 participantunsuitable 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.

Study Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: Maltodextrin
Phase: 3
Study Start date:
February 21, 2024
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • RDC Clinical Pty Ltd

    Brisbane, Queensland 4006
    Australia

    Active - Recruiting

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