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| Name | Class |
|---|---|
| Maolac | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose Maolactin | Experimental | Maolactin 500mg per day - 2 capsules containing 250mg active proteins per capsule; equivalent to 500mg active proteins per day |
|
| 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 |
|
| Maltodextrin | Placebo Comparator | Placebo capsule - 2 capsules containing Maltodextrin per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.](streamdown:incomplete-link)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical Pty Ltd | Brisbane | Queensland | 4006 | Australia |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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| 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 |
|
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 |