Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001148965
Ethics application status
Approved
Date submitted
26/09/2019
Date registered
2/11/2020
Date last updated
29/09/2024
Date data sharing statement initially provided
2/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Modulation of the Gastrointestinal Microbiome with probiotics and subsequent Methane production as a novel approach to treat constipation
Scientific title
Modulation of the Gastrointestinal Microbiome with probiotics and subsequent Methane production as a novel approach to treat constipation
Secondary ID [1] 299415 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
constipation 314592 0
Condition category
Condition code
Oral and Gastrointestinal 312930 312930 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single center, randomized, double-blind, controlled study in which patients are randomised to placebo, and different doses of a patented mixture of probiotic strains.

Patients will be randomised according to a random block procedure at between 1 and 4 weeks after the baseline assessment to receive either for 30 days a probiotic strain mixture at a dose of 25 billion Colony-forming units in diffusion chambers (cfu/d) with food or probiotics at a dose of 50 billion Colony-forming units in diffusion chambers (cfu/d) with food or identical placebo.
Probiotic - Bifidobacterium lactis SFI 105 B. longum SFI 009 Lactobacillus plantarum SFI 219 L. rhamnosus SFI 220 L. acidophilus SFI 201 L. casei SFI 207 L. reuteri
SFI 223
Adherence will be monitored by drug tablet return
Intervention code [1] 315664 0
Treatment: Other
Comparator / control treatment
Placebo: Microcrystalline cellulose (70%w/w), Sodium Alginate (20%w/w), Calcium Carbonate (6.5%w/w) and Stearic Acid (3.5% w/w)
Control group
Placebo

Outcomes
Primary outcome [1] 321529 0
Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire- constipation severity
Timepoint [1] 321529 0
Baseline single assessment and a single assessment at any point between day 25 and 30 post baseline
Primary outcome [2] 321530 0
Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) – impact of Constipation
Timepoint [2] 321530 0
Baseline single assessment and a single assessment at any point between day 25 and 30 post baseline
Primary outcome [3] 321531 0
Methane production is assessed via a hydrogen breath test after a glucose test meal
Timepoint [3] 321531 0
Baseline single assessment and a single assessment at any point between day 25 and 30 post baseline
Secondary outcome [1] 375257 0
Methanogenic gut flora VOC markers assessed from intestinal mucosal biopsy samples (gastric and duodenal)
Timepoint [1] 375257 0
Baseline single assessment and a single assessment at any point between day 25 and 30 post baseline
Secondary outcome [2] 375258 0
Hospital and Anxiety and Depression Scale – anxiety and depression
Timepoint [2] 375258 0
Baseline single assessment and a single assessment at any point between day 25 and 30 post baseline
Secondary outcome [3] 375259 0
Total SAGIS score- symptom burden
Timepoint [3] 375259 0
Baseline single assessment and a single assessment at any point between day 25 and 30 post baseline
Secondary outcome [4] 385739 0
DNA extracted from stool specimens will be used to assess specific changes in stool microbial communities
Timepoint [4] 385739 0
Baseline single assessment and a single assessment at any point between day 25 and 30 post baseline
Secondary outcome [5] 385740 0
Inflammatory blood markers and cytokines including interleukin-8 (IL-8), interleukin-1ß (IL-1ß), interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor (TNF), and interleukin-12p70 (IL-12p70)
Timepoint [5] 385740 0
Baseline single assessment and a single assessment at any point between day 25 and 30 post baseline

Eligibility
Key inclusion criteria
18 years of age and older
Presence of constipation symptoms for at least 6 months and in the first instance a baseline methane exhalations > 10 ppm.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients younger than 18 years and older than 80 years of age.
Exclusion of any relevant conditions that can interfere with the study objectives including:
Medical co morbidities that are related to constipation
Diagnosis of diabetes
Previous surgery that may account for constipation
Receiving ongoing antibiotic treatment

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
A single center, randomized, double-blind, controlled study in which patients are randomised to placebo, and different doses of a patented mixture of probiotic strains.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis of variance to explore the effects of treatment and dose on the respective outcome parameters.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/11/2020
Actual
22/09/2021
Date of last participant enrolment
Anticipated
28/12/2025
Actual
Date of last data collection
Anticipated
28/01/2026
Actual
Sample size
Target
90
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14870 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 28137 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 303922 0
Charities/Societies/Foundations
Name [1] 303922 0
Princess Alexandra Hospital Hospital Foundation
Country [1] 303922 0
Australia
Primary sponsor type
Hospital
Name
Metro South Hosptial and Health Service
Address
199 Ipswich Rd
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 304075 0
Other
Name [1] 304075 0
Translational Research Institute
Address [1] 304075 0
37 Kent St
Woolloongabba QLD 4102
Country [1] 304075 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304423 0
Metro South HREC
Ethics committee address [1] 304423 0
Ethics committee country [1] 304423 0
Australia
Date submitted for ethics approval [1] 304423 0
14/03/2019
Approval date [1] 304423 0
25/06/2019
Ethics approval number [1] 304423 0
HREC/2019/QMS/47579

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

Contacts
Principal investigator
Name 96906 0
Prof Gerald Holtmann
Address 96906 0
Department of Gastroenterology & Hepatology
Princess Alexandra Hospital
Woolloongabba QLD 4102
Country 96906 0
Australia
Phone 96906 0
+61 07 3176 7792
Fax 96906 0
+61 7 3176 5111
Email 96906 0
[email protected]
Contact person for public queries
Name 96907 0
Natasha Koloski
Address 96907 0
Department of Gastroenterology & Hepatology
Princess Alexandra Hospital
Woolloongabba QLD 4102
Country 96907 0
Australia
Phone 96907 0
+61 0407126897
Fax 96907 0
+61 7 3176 5111
Email 96907 0
[email protected]
Contact person for scientific queries
Name 96908 0
Gerald Holtmann
Address 96908 0
Department of Gastroenterology & Hepatology
Princess Alexandra Hospital
Woolloongabba QLD 4102
Country 96908 0
Australia
Phone 96908 0
+61 07 3176 7792
Fax 96908 0
+61 7 3176 5111
Email 96908 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only group results will be reported


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.