Gastrointestinal DysfunctionPhase 3NCT06104917
Effect of Maolactin on Gastrointestinal Tract (GIT) Health
A Phase 3 study testing High Dose Maolactin, Low Dose Maolactin and Maltodextrin in people with Gastrointestinal Dysfunction, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Dysfunction
- What is being tested?
- High Dose Maolactin, Low Dose Maolactin and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteAustralia
- Study dates
- 21 Feb 2024to 23 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of MaolactinTM Supplement on Gastrointestinal Tract (GIT) Health in Adult Subjects: a Double-blind Randomized Placebo-controlled Study
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
- Being tested
- High Dose Maolactin, Low Dose Maolactin, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dose MaolactinDrug
Once daily dose of 2 capsules (2 capsules containing 250mg active proteins per capsule; equivalent to 500mg active proteins per day)
Low Dose MaolactinDrug
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)
MaltodextrinDrug
Once daily dose of 2 capsules
| Study group | Role | What they receive |
|---|---|---|
| High Dose Maolactin | Experimental | Maolactin 500mg per day - 2 capsules containing 250mg active proteins per capsule; equivalent to 500mg active proteins per day Receives: 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 Receives: Drug: Low Dose Maolactin |
| Maltodextrin | Placebo comparator | Placebo capsule - 2 capsules containing Maltodextrin per day Receives: Drug: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in upper gastrointestinal symptoms
Change in upper gastrointestinal symptoms as measured by Gastrointestinal Symptom Rating Scale (GSRS)
Measured: Day -28, Day 0, Day 14, Day 28, Day 56
Secondary outcomes (12)
Change in upper gastrointestinal symptoms
Change in upper gastrointestinal symptoms as measured by Gastroesophageal Reflux Disease Questionnaire (GerdQ)
Measured: Day -28, Day 0, Day 14, Day 28, Day 56
Change in upper gastrointestinal symptoms
Change in upper gastrointestinal symptoms as measured by Bloating Symptoms VAS (BSVAS)
Measured: Day -28, Day 0, Day 14, Day 28, Day 56
Change in gut microbiome
Change in gut microbiome as measured by stool sample analysis
Measured: Day 0, Day 56
Change in stool frequency and consistency
Change in stool frequency and consistency as measured by Bristol Stool Chart
Measured: Day -28, Day 0, Day 14, Day 28, Day 56
Change in intestinal permeability
Change in intestinal permeability as measured by Plasma Zonulin via blood sample
Measured: Day 0, Day 56
Change in intestinal permeability
Change in intestinal permeability as measured by 6 hour urine test
Measured: Day 0, Day 56
Change in gut inflammation
Change in gut inflammation as measured by faecal calprotectin via stool sample
Measured: Day 0, Day 56
Change in quality of life
Change in quality of life as measured by Digestion-associated Quality of Life Questionnaire (DQLQ)
Measured: Day -28, Day 0, Day 14, Day 28, Day 56
Change in diet
Change in diet as measured by 24-hour Dietary Recall
Measured: Days -27, -26, -25, Days -3, -2, -1, Days 25, 26, 27, Days 53, 54, 55
Change in inflammatory markers
Change in inflammation as measured by inflammatory markers (TNFα, interleukin (IL)-1β, IL-6, and IL-8, CRP, Nf-Kb) via blood test
Measured: Day 0, Day 56
Change in safety
Change in safety as measured by E/LFT via including cholesterol and glucose via blood sample
Measured: Day 0, Day 56
Change in safety
Change in safety as measured by adverse events
Measured: Day -28 to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start21 Feb 2024
- Primary completion23 Jul 2025
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DysfunctionStudies of the same condition, open and under way.
- More trials run by RDC Clinical Pty LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Maolac
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104917
- Sponsor's protocol ID
- MAOGIT
- Status last verified
- Jun 2025
- First submitted
- 23 Oct 2023
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of MaolactinTM Supplement on Gastrointestinal Tract (GIT) Health in Adult Subjects: a Double-blind Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06104917
- Acronym / sponsor ID
- MAOGIT
- Conditions
- Gastrointestinal Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Maolac
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 23 Jul 2025 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose Maolactin | Experimental | Drug: High Dose MaolactinMaolactin 500mg per day - 2 capsules containing 250mg active proteins per capsule; equivalent to 500mg active proteins per day |
| Low Dose Maolactin | Experimental | Drug: Low Dose MaolactinMaolactin 250mg per day - 1 capsule containing 250mg active proteins per capsule and 1 capsule containing maltodextrin only; equivalent to 250mg active proteins per day |
| Maltodextrin | Placebo comparator | Drug: MaltodextrinPlacebo capsule - 2 capsules containing Maltodextrin per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Dose MaolactinOnce daily dose of 2 capsules (2 capsules containing 250mg active proteins per capsule; equivalent to 500mg active proteins per day) | Drug | High Dose Maolactin |
| Low Dose MaolactinOnce 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) | Drug | Low Dose Maolactin |
| MaltodextrinOnce daily dose of 2 capsules | Drug | Maltodextrin |
Primary outcome
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)
12 secondary outcomes
Change in upper gastrointestinal symptoms
Time frame: Day -28, Day 0, Day 14, Day 28, Day 56
Change in upper gastrointestinal symptoms
Time frame: Day -28, Day 0, Day 14, Day 28, Day 56
Change in gut microbiome
Time frame: Day 0, Day 56
Change in stool frequency and consistency
Time frame: Day -28, Day 0, Day 14, Day 28, Day 56
Change in intestinal permeability
Time frame: Day 0, Day 56
Change in intestinal permeability
Time frame: Day 0, Day 56
Change in gut inflammation
Time frame: Day 0, Day 56
Change in quality of life
Time frame: Day -28, Day 0, Day 14, Day 28, Day 56
Change in diet
Time frame: Days -27, -26, -25, Days -3, -2, -1, Days 25, 26, 27, Days 53, 54, 55
Change in inflammatory markers
Time frame: Day 0, Day 56
Change in safety
Time frame: Day 0, Day 56
Change in safety
Time frame: Day -28 to Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing High Dose Maolactin, Low Dose Maolactin and Maltodextrin in people with Gastrointestinal Dysfunction, run by RDC Clinical Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in upper gastrointestinal symptoms (time frame: Day -28, Day 0, Day 14, Day 28, Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.