Effect of Maolactin on Gastrointestinal Tract (GIT) Health

NCT06104917 | Completed Phase 3

• 1 other identifier: MAOGIT
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in upper gastrointestinal symptoms

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

  Day -28, Day 0, Day 14, Day 28, Day 56

Secondary Outcomes (12)

• Change in upper gastrointestinal symptoms

  Day -28, Day 0, Day 14, Day 28, Day 56

• Change in upper gastrointestinal symptoms

  Day -28, Day 0, Day 14, Day 28, Day 56

• Change in gut microbiome

  Day 0, Day 56

• Change in stool frequency and consistency

  Day -28, Day 0, Day 14, Day 28, Day 56

• Change in intestinal permeability

  Day 0, Day 56

Study Arms (3)

High Dose Maolactin

EXPERIMENTAL

Maolactin 500mg per day - 2 capsules containing 250mg active proteins per capsule; equivalent to 500mg active proteins per day

Drug: High Dose Maolactin

Low Dose Maolactin

EXPERIMENTAL

Maolactin 250mg per day - 1 capsule containing 250mg active proteins per capsule and 1 capsule containing maltodextrin only; equivalent to 250mg active proteins per day

Drug: Low Dose Maolactin

Maltodextrin

PLACEBO COMPARATOR

Placebo capsule - 2 capsules containing Maltodextrin per day

Drug: Maltodextrin

Interventions

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)

High Dose Maolactin

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)

Low Dose Maolactin

Maltodextrin DRUG

Once daily dose of 2 capsules

Maltodextrin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead
• Maolac: collaborator

Study Sites (1)

RDC Clinical Pty Ltd

Brisbane, Queensland, 4006, Australia

Location

MeSH Terms

Interventions

maltodextrin

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: February 21, 2024
• Primary Completion: July 23, 2025
• Study Completion: July 23, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)