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Completed

NCT Number: NCT06104917

Effect of Maolactin on Gastrointestinal Tract (GIT) Health

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.

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Key information

Conditions

Gastrointestinal Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

RDC Clinical Pty Ltd

Brisbane, Queensland, 4006, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Dose Maolactin

Drug

Once daily dose of 2 capsules (2 capsules containing 250mg active proteins per capsule; equivalent to 500mg active proteins per day)

Low Dose Maolactin

Drug

Once daily dose of 2 capsules (1 capsule containing 250mg active proteins per capsule and 1 capsule containing maltodextrin only; equivalent to 250mg active proteins per day)

Maltodextrin

Drug

Once daily dose of 2 capsules

Primary outcomes

  1. Change in upper gastrointestinal symptoms

    Time frame: Day -28, Day 0, Day 14, Day 28, Day 56

    Change in upper gastrointestinal symptoms as measured by Gastrointestinal Symptom Rating Scale (GSRS)

Secondary outcomes

  1. Change in upper gastrointestinal symptoms

    Time frame: Day -28, Day 0, Day 14, Day 28, Day 56

    Change in upper gastrointestinal symptoms as measured by Gastroesophageal Reflux Disease Questionnaire (GerdQ)

  2. Change in upper gastrointestinal symptoms

    Time frame: Day -28, Day 0, Day 14, Day 28, Day 56

    Change in upper gastrointestinal symptoms as measured by Bloating Symptoms VAS (BSVAS)

  3. Change in gut microbiome

    Time frame: Day 0, Day 56

    Change in gut microbiome as measured by stool sample analysis

  4. Change in stool frequency and consistency

    Time frame: Day -28, Day 0, Day 14, Day 28, Day 56

    Change in stool frequency and consistency as measured by Bristol Stool Chart

  5. Change in intestinal permeability

    Time frame: Day 0, Day 56

    Change in intestinal permeability as measured by Plasma Zonulin via blood sample

  6. Change in intestinal permeability

    Time frame: Day 0, Day 56

    Change in intestinal permeability as measured by 6 hour urine test

  7. Change in gut inflammation

    Time frame: Day 0, Day 56

    Change in gut inflammation as measured by faecal calprotectin via stool sample

  8. Change in quality of life

    Time frame: 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)

  9. Change in diet

    Time frame: 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

  10. Change in inflammatory markers

    Time frame: 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

  11. Change in safety

    Time frame: Day 0, Day 56

    Change in safety as measured by E/LFT via including cholesterol and glucose via blood sample

  12. Change in safety

    Time frame: Day -28 to Day 56

    Change in safety as measured by adverse events

Sponsors and collaborators

Lead sponsor

RDC Clinical Pty Ltd

Industry

Collaborators

  • Maolac

Registry information

Official study title

Effect of MaolactinTM Supplement on Gastrointestinal Tract (GIT) Health in Adult Subjects: a Double-blind Randomized Placebo-controlled Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 27, 2023
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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