Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000806460p
Ethics application status
Submitted, not yet approved
Date submitted
21/07/2025
Date registered
29/07/2025
Date last updated
29/07/2025
Date data sharing statement initially provided
29/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
An examination into the effects of a probiotic and digestive enzyme combination (Weizy and Poolzyme MULTI) in adults experiencing self-reported digestive complaints: a randomised, double-blind, placebo-controlled trial
Scientific title
An examination into the effects of a probiotic and digestive enzyme combination (Weizy and Poolzyme MULTI) in adults experiencing self-reported digestive complaints: a randomised, double-blind, placebo-controlled trial
Secondary ID [1] 314955 0
None
Universal Trial Number (UTN)
U1111-1325-6362
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal disturbances 338274 0
Condition category
Condition code
Oral and Gastrointestinal 334573 334573 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Alternative and Complementary Medicine 334574 334574 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 331556 0
Treatment: Other
Comparator / control treatment
A matching placebo (maltodextrin) capsule in terms of taste and appearance, and containing all ingredients/excipients except the active ingredient (Weizy + Poolzyme MULTI)
Control group
Placebo

Outcomes
Primary outcome [1] 342248 0
Gastrointestinal symptoms: Abdominal pain
Timepoint [1] 342248 0
Days 0 (pre-commencement of intervention), 14, 28 (primary endpoint) and 42 post-intervention commencement
Primary outcome [2] 342249 0
Gastrointestinal symptoms: Indigestion
Timepoint [2] 342249 0
Days 0 (pre-commencement of intervention), 14, 28 (primary endpoint) and 42 post-intervention commencement
Secondary outcome [1] 450099 0
Gastrointestinal symptoms: Reflux
Timepoint [1] 450099 0
Days 0 (pre-commencement of intervention), 14, 28 and 42 post-intervention commencement
Secondary outcome [2] 450100 0
Gastrointestinal symptoms: Diarrhoea
Timepoint [2] 450100 0
Days 0 (pre-commencement of intervention), 14, 28 and 42 post-intervention commencement
Secondary outcome [3] 450101 0
Gastrointestinal symptoms: Constipation
Timepoint [3] 450101 0
Days 0 (pre-commencement of intervention), 14, 28 and 42 post-intervention commencement
Secondary outcome [4] 450102 0
Stool form
Timepoint [4] 450102 0
Daily records starting day 1 (one day after commencement of intervention) to day 28 post-intervention commencement.
Secondary outcome [5] 450103 0
Daily bowel movements
Timepoint [5] 450103 0
Daily records starting day 1 (one day after commencement of intervention) to day 28 post-intervention commencement.
Secondary outcome [6] 450104 0
Abdominal pain
Timepoint [6] 450104 0
Daily records starting day 1 (one day after commencement of intervention) to day 28 post-intervention commencement.
Secondary outcome [7] 450105 0
Global Impression of Change
Timepoint [7] 450105 0
Days 14, 28 and 42 post-intervention commencement
Secondary outcome [8] 450106 0
Physical function
Timepoint [8] 450106 0
Days 0 (pre-commencement of intervention), 14, 28 and 42 post-intervention commencement
Secondary outcome [9] 450107 0
Anxiety
Timepoint [9] 450107 0
Days 0 (pre-commencement of intervention), 14, 28 and 42 post-intervention commencement
Secondary outcome [10] 450108 0
Depression
Timepoint [10] 450108 0
Days 0 (pre-commencement of intervention), 14, 28 and 42 post-intervention commencement
Secondary outcome [11] 450109 0
Fatigue
Timepoint [11] 450109 0
Days 0 (pre-commencement of intervention), 14, 28 and 42 post-intervention commencement
Secondary outcome [12] 450110 0
Sleep
Timepoint [12] 450110 0
Days 0 (pre-commencement of intervention), 14, 28 and 42 post-intervention commencement
Secondary outcome [13] 450111 0
Social activity
Timepoint [13] 450111 0
Days 0 (pre-commencement of intervention), 14, 28 and 42 post-intervention commencement
Secondary outcome [14] 450112 0
Pain
Timepoint [14] 450112 0
Days 0 (pre-commencement of intervention), 14, 28 and 42 post-intervention commencement

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opaque numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
12/01/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 319513 0
Commercial sector/Industry
Name [1] 319513 0
Giellepi S.p.A
Country [1] 319513 0
Italy
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
Country
Australia
Secondary sponsor category [1] 322009 0
Commercial sector/Industry
Name [1] 322009 0
Giellepi S.p.A
Address [1] 322009 0
Country [1] 322009 0
Italy

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318088 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 318088 0
Ethics committee country [1] 318088 0
Australia
Date submitted for ethics approval [1] 318088 0
07/07/2025
Approval date [1] 318088 0
Ethics approval number [1] 318088 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143074 0
Dr Adrian Lopresti
Address 143074 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 143074 0
Australia
Phone 143074 0
+61 8 94487376
Fax 143074 0
Email 143074 0
[email protected]
Contact person for public queries
Name 143075 0
Adrian Lopresti
Address 143075 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 143075 0
Australia
Phone 143075 0
+61 8 94487376
Fax 143075 0
Email 143075 0
[email protected]
Contact person for scientific queries
Name 143076 0
Adrian Lopresti
Address 143076 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 143076 0
Australia
Phone 143076 0
+61 8 94487376
Fax 143076 0
Email 143076 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• Individual participant data underlying published results

What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.