Effect of Maolactin on Gastrointestinal Tract (GIT) Health

Gastrointestinal Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06104917
• Other study ID #: MAOGIT
• Status: Recruiting
• Phase: Phase 3
• Start date: February 21, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2024
• Source: RDC Clinical Pty Ltd
• Contact: Amanda Rao, PhD
• Phone: +61 414 488 559
• Email: amanda[@]rdcglobal.com.au
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 28, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Dysfunction

Intervention

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

Locations

Country	Name	City	State
Australia	RDC Clinical Pty Ltd	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
RDC Clinical Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change in gut microbiome	Change in gut microbiome as measured by stool sample analysis	Day 0, Day 56
Secondary	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
Secondary	Change in intestinal permeability	Change in intestinal permeability as measured by Plasma Zonulin via blood sample	Day 0, Day 56
Secondary	Change in intestinal permeability	Change in intestinal permeability as measured by 6 hour urine test	Day 0, Day 56
Secondary	Change in gut inflammation	Change in gut inflammation as measured by faecal calprotectin via stool sample	Day 0, Day 56
Secondary	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
Secondary	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
Secondary	Change in inflammatory markers	Change in inflammation as measured by inflammatory markers (TNFa, interleukin (IL)-1ß, IL-6, and IL-8, CRP, Nf-Kb) via blood test	Day 0, Day 56
Secondary	Change in safety	Change in safety as measured by E/LFT via including cholesterol and glucose via blood sample	Day 0, Day 56
Secondary	Change in safety	Change in safety as measured by adverse events	Day -28 to Day 56