None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 100 adults aged 18 to 75 years with self-reported GI complaints will be randomly assigned to receive a probiotic and digestive enzyme combination (Weizy + Poolzyme MULTI) or a placebo for 4 weeks. Changes in self-reported gastrointestinal symptoms, stool consistency, and general well-being will be assessed for 6 weeks to examine changes in symptoms during and 2 weeks after the cessation of supplementation. It is hypothesised that compared to the placebo, supplementation with the probiotic and digestive enzyme combination (Weizy + Poolzyme MULTI) will result in greater improvement in gastrointestinal symptoms, stool consistency, and general wellbeing.
Interventions
Probiotic and digestive enzyme combination (Weizy + Poolzyme MULTI) or placebo capsules for 4 weeks (1 capsule taken orally, twice daily, at the start of main meals, preferably with dinner, and breakfast OR lunch). Each active capsule will contain 200 mg of Poolzyme MULTI and 60mg (2 billion CFU/g) of Weizy, Adherence to capsule intake will be measured by a count of capsules returned at week 4.
Probiotic and digestive enzyme combination (Weizy + Poolzyme MULTI) or placebo capsules for 4 weeks (1 capsule taken orally, twice daily, at the start of main meals, preferably with dinner, and breakfast OR lunch). Each active capsule will contain 200 mg of Poolzyme MULTI and 60mg (3 billion CFU/g) of Weizy, Adherence to capsule intake will be measured by a count of capsules returned at week 4.
Sponsors
Clinical Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Generally healthy adults (male and female) aged between 18 to 75 years. 2. At least an 8-week history of gastrointestinal complaints such as recurrent abdominal pain, discomfort, bloating, or distention associated with a change in the frequency of bowel movements, and/or a change in the form (appearance) of stool. 3. Mean scores of 3 or more on abdominal pain or indigestion questions in the Gastrointestinal Symptom Rating Scale. 4. Consumes at least 2 meals daily, comprising breakfast, lunch or dinner. 5. Non-smoker. 6. BMI between 18 and 30 kg/m2. 7. No plan to commence new treatments over the study period. 8. Understand, willing and able to comply with all study procedures. 9. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Exclusion criteria
1. A history of major gastrointestinal surgery. 2. Alarm features associated with bowel habits, such as recent changes in bowel habits (onset less than three months), rectal bleeding, sudden weight loss, occult blood in stool, anaemia, anal fissures, bleeding haemorrhoids, or a significant family history of irritable bowel disease or gastrointestinal cancer at a young age. 3. Medical conditions, including but not limited to: active or a history of inflammatory bowel disease, diagnosis of gastroparesis, active/ongoing infection, uncontrolled diabetes mellitus, chronic renal failure, liver disease, cardiac disease, severe chronic obstructive pulmonary disease, significant neurological disease, cancer/ malignancy in the last 5 years, diagnosed lactose or fructose intolerance, immunocompromised or have an immunodeficiency syndrome of any kind. 4. Diagnosis of infectious gastroenteritis within 1 month before screening. 5. Any significant surgeries over the last year that continue to affect daily function or planned surgery during the study period. 6. Started any new treatment for digestive symptoms in the last 8 weeks. 7. Use of any antibiotics, antifungals, antivirals, or antiparasitic medicines within 8 weeks before screening. 8. Use of antipsychotic medications or systemic steroids within 3 months before screening. 9. Currently taking the following medications more than three days a week: opiates, non-steroidal anti-inflammatory drugs, laxatives, anti-diarrhoeals, cholestyramine, colchicine, iron supplements, antispasmodics, or benzodiazepines. 10. In the last 4 weeks before screening, commenced or changed prescription medications or have an expectation to change during the study period. 11. In the last 4 weeks before screening, the use of supplements containing probiotics, prebiotics, or digestive enzymes, or having an expectation to start during the study period. 12. In the last 4 weeks before screening, commenced or changed over-the-counter supplements that may affect digestive function, or have an expectation to change during the study period. 13. Dietary or lifestyle changes in the last 8 weeks that might affect GI function, or having an expectation to make changes during the study period. 14. Alcohol intake greater than 14 standard drinks per week. 15. Current or 12-month history of regular illicit drug use. 16. Pregnant women, women who are breastfeeding, or women who intend to fall pregnant during the study period. 17. Participation in any other clinical trial in the last 4 weeks.
Outcome results
None listed