Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000878279
Ethics application status
Approved
Date submitted
21/05/2018
Date registered
23/05/2018
Date last updated
19/09/2019
Date data sharing statement initially provided
19/09/2019
Date results provided
19/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Nutrition-Care Gut Relief Formula on Gastrointestinal Disturbances: The Gut Relief Study
Scientific title
Single-arm pre-post dose-response study of 16 weeks duration investigating the effect of the Nutrition Care Gut Relief Formula on gastrointestinal disturbances in Australian adults.
Secondary ID [1] 294941 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
moderate gastrointestinal disturbances of the upper or lower gastrointestinal tract 307913 0
dyspepsia 307914 0
Condition category
Condition code
Oral and Gastrointestinal 306957 306957 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 306958 306958 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single-arm pre-post dose-response study of 16 weeks duration investigating the effect of the Nutrition-Care Gut-Relief-Formula on gastrointestinal disturbances in Australian adults. After a run-in-phase of 4 weeks of observation only, the intervention will comprise 5g powder in sachets per day of the Gut-Relief Formula for 4 weeks, followed by 10g powder in sachets per day of the Gut-Relief Formula for 2x4 weeks. The commercially available Gut-Relief Formula contains a mixture of 10 herbs and nutrients*, which have individually shown to relief gastrointestinal disturbances. Adherence will be assessed after 4, 8 and 12 weeks by count of remaining sachets of the investigational product
* The Gut Relief Formula powder - to be dissolved in water - contains Curcuma, Glutamine, Quercetin, Glucosamin hydrochloride, Aloe vera, Ulmus rubra, Guar gum, Pectin, Peppermint oil, Sodium phosphate.
Intervention code [1] 301263 0
Treatment: Other
Comparator / control treatment
Run-in phase of 4 weeks with no intervention, baseline data will be compared to data at enrolment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305946 0
Symptom Relief
measured by questionnaires
Questionnaires: Dyspepsia Leeds Short Form, Bristol stool chart, Birmingham IBS Symptom Q, GERD-Q Symptom Score, Pain-VAS scale, Tolerability, other symptoms Q
Timepoint [1] 305946 0
12, 8, 4 weeks of intervention compared to baseline (0 weeks) and before run-in phase (-4 weeks)
Primary outcome [2] 305947 0
Quality of Life
assessed by questionnaires: IBS-QoL, GERD-QoL, GERD-Health related QoL
Timepoint [2] 305947 0
12, 8, 4 weeks of intervention compared to baseline (0 weeks) and before run-in phase (-4 weeks)
Primary outcome [3] 305949 0
Composite primary outcome: Microbial Character by Stool test by multiplex PCR-DNA analysis to assess microbial richness and microbial diversity, and Firmicute/Bacteroides Ratio
Timepoint [3] 305949 0
12 weeks of intervention compared to baseline (0 weeks) after run-in phase
Secondary outcome [1] 347090 0
Inflammatory markers by serum assay:
TNF-alpha, IL-1 beta, IL6, IL8
Timepoint [1] 347090 0
12 weeks of intervention compared to baseline (0 weeks) after run-in phase
Secondary outcome [2] 347091 0
Intestinal permeability/ leaky gut: by urine test kit
Lactulose/Mannitol ratio
Timepoint [2] 347091 0
12 weeks of intervention compared to baseline (0 weeks) after run-in phase

Eligibility
Key inclusion criteria
Adults with moderate gastrointestinal disturbances (upper and/or lower gastrointestinal tract).
Participants may experience one or multiple symptoms at least once a week for at least 3 months:

Of the upper gastrointestinal tract:
Suffering from Indigestion, Heartburn, Regurgitation, and/or Nausea at least once weekly for at least 3 months assessed by Short Form Leeds dyspepsia questionnaire
and/or
Of the lower gastrointestinal tract:
IBS-like symptoms, assessed by the ROME IV criteria
a. IBS with predominant constipation: Bristol stool type 1 & 2 (more than 25%), type 6 & 7 (< 25%)
b. IBS with predominant diarrhea: Bristol stool type 1 & 2 (< 25%), type6 & 7 (more than 25%)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Gastrointestinal disturbances due to other causes, e.g. pregnancy, cancer
• If applicable, has been on medication for at least 2 months
• Planned surgery, medication change in the next 3-4 months/ during the study
• Intolerance or allergy to any of the ingredients in the Gut Relief Formula

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No allocation concealment. After a run-in period of 4 weeks, all participants will be allocated to 5g/ day of Gut-Relief Formula for 4 weeks, and 10g/ day of Gut Relief Formula for 2x4 weeks.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
pre-post study design: 4 week run-in phase will serve as control = pre = before intervention
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be performed using SPSS (PASW version 18). Statistical significance will be set at p<0.05. This is a pilot study and differences within the group (pre- and post-intervention) will be analysed with repeated measures ANOVA at 4, 8, and 12 weeks compared to baselines at 0 and -4 weeks (before run-in as control) for questionnaires, and at 12 weeks compared to baseline (0 weeks) for stool, urine, and blood tests. Subgroup analysis of participants with only upper or only lower gastrointestinal symptoms will be explored.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/06/2018
Actual
4/06/2018
Date of last participant enrolment
Anticipated
4/02/2019
Actual
4/02/2019
Date of last data collection
Anticipated
4/06/2019
Actual
3/05/2019
Sample size
Target
50
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 22724 0
3122 - Hawthorn
Recruitment postcode(s) [2] 22725 0
3123 - Auburn
Recruitment postcode(s) [3] 22726 0
3121 - Burnley

Funding & Sponsors
Funding source category [1] 299526 0
Commercial sector/Industry
Name [1] 299526 0
Nutrition Care Pharmaceuticals Pty Ltd
Country [1] 299526 0
Australia
Primary sponsor type
Individual
Name
A/Prof Dr Karin Ried
Address
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
Country
Australia
Secondary sponsor category [1] 298859 0
None
Name [1] 298859 0
Address [1] 298859 0
Country [1] 298859 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300423 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 300423 0
Ethics committee country [1] 300423 0
Australia
Date submitted for ethics approval [1] 300423 0
09/04/2018
Approval date [1] 300423 0
21/05/2018
Ethics approval number [1] 300423 0
0044N_2018

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

Contacts
Principal investigator
Name 83618 0
A/Prof Karin Ried
Address 83618 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
Country 83618 0
Australia
Phone 83618 0
+ 61 3 9912 9545
Fax 83618 0
Email 83618 0
[email protected]
Contact person for public queries
Name 83619 0
Karin Ried
Address 83619 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
Country 83619 0
Australia
Phone 83619 0
+ 61 3 9912 9545
Fax 83619 0
Email 83619 0
[email protected]
Contact person for scientific queries
Name 83620 0
Karin Ried
Address 83620 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
Country 83620 0
Australia
Phone 83620 0
+ 61 3 9912 9545
Fax 83620 0
Email 83620 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
no individual data will be divulged to respect participant privacy; however summary de-identified data will be shared in peer-reviewed publication


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
SourceTitleYear of PublicationDOI
EmbaseHerbal formula improves upper and lower gastrointestinal symptoms and gut health in Australian adults with digestive disorders.2020https://dx.doi.org/10.1016/j.nutres.2020.02.008
N.B. These documents automatically identified may not have been verified by the study sponsor.