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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06104917




Registration number
NCT06104917
Ethics application status
Date submitted
23/10/2023
Date registered
27/10/2023
Date last updated
3/04/2024

Titles & IDs
Public title
Effect of Maolactin on Gastrointestinal Tract (GIT) Health
Scientific title
Effect of MaolactinTM Supplement on Gastrointestinal Tract (GIT) Health in Adult Subjects: a Double-blind Randomized Placebo-controlled Study
Secondary ID [1] 0 0
MAOGIT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Dysfunction 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - High Dose Maolactin
Treatment: Drugs - Low Dose Maolactin
Treatment: Drugs - Maltodextrin

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

Experimental: Low Dose Maolactin - 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

Placebo comparator: Maltodextrin - Placebo capsule - 2 capsules containing Maltodextrin per day


Treatment: Drugs: High Dose Maolactin
Once daily dose of 2 capsules (2 capsules containing 250mg active proteins per capsule; equivalent to 500mg active proteins per day)

Treatment: Drugs: Low Dose Maolactin
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)

Treatment: Drugs: Maltodextrin
Once daily dose of 2 capsules
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in upper gastrointestinal symptoms
Timepoint [1] 0 0
Day -28, Day 0, Day 14, Day 28, Day 56
Secondary outcome [1] 0 0
Change in upper gastrointestinal symptoms
Timepoint [1] 0 0
Day -28, Day 0, Day 14, Day 28, Day 56
Secondary outcome [2] 0 0
Change in upper gastrointestinal symptoms
Timepoint [2] 0 0
Day -28, Day 0, Day 14, Day 28, Day 56
Secondary outcome [3] 0 0
Change in gut microbiome
Timepoint [3] 0 0
Day 0, Day 56
Secondary outcome [4] 0 0
Change in stool frequency and consistency
Timepoint [4] 0 0
Day -28, Day 0, Day 14, Day 28, Day 56
Secondary outcome [5] 0 0
Change in intestinal permeability
Timepoint [5] 0 0
Day 0, Day 56
Secondary outcome [6] 0 0
Change in intestinal permeability
Timepoint [6] 0 0
Day 0, Day 56
Secondary outcome [7] 0 0
Change in gut inflammation
Timepoint [7] 0 0
Day 0, Day 56
Secondary outcome [8] 0 0
Change in quality of life
Timepoint [8] 0 0
Day -28, Day 0, Day 14, Day 28, Day 56
Secondary outcome [9] 0 0
Change in diet
Timepoint [9] 0 0
Days -27, -26, -25, Days -3, -2, -1, Days 25, 26, 27, Days 53, 54, 55
Secondary outcome [10] 0 0
Change in inflammatory markers
Timepoint [10] 0 0
Day 0, Day 56
Secondary outcome [11] 0 0
Change in safety
Timepoint [11] 0 0
Day 0, Day 56
Secondary outcome [12] 0 0
Change in safety
Timepoint [12] 0 0
Day -28 to Day 56

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Clinical Pty Ltd - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
RDC Clinical Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06104917
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amanda Rao, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 414 488 559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06104917