Effect of Maolactin on Gastrointestinal Tract (GIT) Health

Study Overview
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Brief Summary
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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.

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

Conditions
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Gastrointestinal Dysfunction

Intervention / Treatment
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* Drug: High Dose Maolactin
* Drug: Low Dose Maolactin
* Drug: Maltodextrin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dose Maolactin<br>Maolactin 250mg capsule - Take 2 capsules once daily before the morning meal. | Drug: High Dose Maolactin<br>* Once daily dose of 2 capsules (250mg per capsule)<br>|
| Experimental: Low Dose Maolactin<br>Maolactin 125mg capsule - Take 2 capsules once daily before the morning meal. | Drug: Low Dose Maolactin<br>* Once daily dose of 2 capsules (125mg per capsule)<br>|
| Placebo Comparator: Maltodextrin<br>Placebo capsule - Take 2 capsules once daily before the morning meal. | Drug: Maltodextrin<br>* Once daily dose of 2 capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in upper gastrointestinal symptoms | Change in upper gastrointestinal symptoms as measured by Gastroesophageal Reflux Disease Questionnaire (GerdQ) | 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) | Day -28, Day 0, Day 14, Day 28, Day 56 | 
| Change in gut microbiome | Change in gut microbiome as measured by stool sample analysis | Day 0, Day 56 | 
| Change in stool frequency and consistency | Change in stool frequency and consistency as measured by Bristol Stool Chart | 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 | Day 0, Day 56 | 
| Change in intestinal permeability | Change in intestinal permeability as measured by 6 hour urine test | Day 0, Day 56 | 
| Change in gut inflammation | Change in gut inflammation as measured by faecal calprotectin via stool sample | Day 0, Day 56 | 
| Change in quality of life | Change in quality of life as measured by Digestion-associated Quality of Life Questionnaire (DQLQ) | Day -28, Day 0, Day 14, Day 28, Day 56 | 
| Change in diet | Change in diet as measured by 24-hour Dietary Recall | 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 | Day 0, Day 56 | 
| Change in safety | Change in safety as measured by E/LFT via including cholesterol and glucose via blood sample | Day 0, Day 56 | 
| Change in safety | Change in safety as measured by adverse events | Day -28 to Day 56 |