Effect of Maolactin on Gastrointestinal Tract (GIT) Health

RDC Clinical

Status and phase: Active, not recruiting; Phase 3

Conditions: Gastrointestinal Dysfunction

Treatments: Drug: High Dose Maolactin; Drug: Maltodextrin; Drug: Low Dose Maolactin

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06104917

MAOGIT

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

High Dose Maolactin

Experimental group

Description:

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

Treatment:

Drug: High Dose Maolactin

Low Dose Maolactin

Experimental group

Description:

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

Treatment:

Drug: Low Dose Maolactin

Maltodextrin

Placebo Comparator group

Description:

Placebo capsule - 2 capsules containing Maltodextrin per day

Treatment:

Drug: Maltodextrin