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Trial registered on ANZCTR


Registration number
ACTRN12619001236189
Ethics application status
Approved
Date submitted
23/08/2019
Date registered
6/09/2019
Date last updated
14/10/2021
Date data sharing statement initially provided
6/09/2019
Date results provided
14/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Curcumin for the Treatment of Digestive Complaints in Adults
Scientific title
Effects of curcumin on digestive symptoms and intestinal bacteria in adults with self-reported digestive complaints: a randomised, double-blind, placebo-controlled study
Secondary ID [1] 299003 0
None
Universal Trial Number (UTN)
U1111-1238-9393
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal complaints 314012 0
Condition category
Condition code
Oral and Gastrointestinal 312400 312400 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One capsule containing 500mg of a proprietary curcumin extract (Curcugen™) will be consumed once daily for 8 weeks by adults aged between 18 and 65 years. Adherence to capsule intake will be monitored through capsule return and count.
Intervention code [1] 315271 0
Treatment: Drugs
Comparator / control treatment
Placebo (containing microcellulose) is matched to the saffron tablets in terms of taste and appearance but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 321041 0
Gastrointestinal symptoms assessed by total score on Gastrointestinal Symptom Rating Scale (GSRS)
Timepoint [1] 321041 0
Days 0, 30, and 60 (primary timepoint)
Primary outcome [2] 321042 0
Taxonomic change in Intestinal bacteria as assessed by stool sample and 16S rRNA gene sequencing
Timepoint [2] 321042 0
Days 0 and 60 (primary timepoint)
Secondary outcome [1] 373769 0
Small Intestinal Bowel Overgrowth (SIBO) as assessed by SIBO lactulose breath test
Timepoint [1] 373769 0
Days 0 and 60
Secondary outcome [2] 373770 0
Mood quality assessed by total score on Depression, Anxiety, and Stress Scale (DASS-21)
Timepoint [2] 373770 0
Days 0, 30 and 60
Secondary outcome [3] 374076 0
General health assessed by Short-Form-36 (SF-36)
Timepoint [3] 374076 0
Days 0, 30, and 60
Secondary outcome [4] 374404 0
Pain assessed by Short-Form-36 (SF-36)
Timepoint [4] 374404 0
Days 0, 30, and 60
Secondary outcome [5] 374640 0
Abdominal pain assessed by Gastrointestinal Symptom Rating Scale (GSRS)
Timepoint [5] 374640 0
Days 0, 30, and 60
Secondary outcome [6] 374641 0
Reflux symptoms assessed by Gastrointestinal Symptom Rating Scale (GSRS)
Timepoint [6] 374641 0
Days 0, 30, and 60
Secondary outcome [7] 374642 0
Indigestion symptoms assessed by Gastrointestinal Symptom Rating Scale (GSRS)
Timepoint [7] 374642 0
Days 0, 30, and 60

Eligibility
Key inclusion criteria
1. Healthy adults (male and female) between 18 and 65
2. Mild-to-moderate severity gastrointestinal complaints as measured by the Gastrointestinal Symptom Rating Scale (GSRS) (total score between 10 and 29)
3. Medication-free for at least 3 months. Use of analgesics (once a week) or contraceptive pills are permissible.
4. Non-smoker
5. BMI between 20 and 35
6. No plan to change diet or commence new treatments over study period
7. Willing to complete an online informed consent form detailing all pertinent aspects of the trial
8. Willing and able to take prescribed curcumin/placebo capsules for 8 weeks
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Alcohol consumption > 14 standard drinks per week
2. Current or 12-month history of illicit drug abuse
3. Pregnant women, women who are breastfeeding or women who intended to fall pregnant.
4. Suffering from medical conditions including but not limited to: gastrointestinal disease, functional gastrointestinal disorder, diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease/gallstones/biliary disease, endocrine disease, psychiatric disorder, and neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury)
5. Currently taking curcumin supplements
6. Antibiotic use in the 4-weeks prior to study commencement
7. Current use of supplements that may affect digestive function, unless been on stable dose over last 60 days before baseline assessment
8. Currently taking prebiotic or probiotic supplements

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)
Participants will be randomly allocated into placebo and treatment groups. These groups are named group 1 and group 2 and the primary investigator and participants will be unaware of which treatment these groups represent. Each participant will be allocated a participant number (1 to 80) based on the order of inclusion in the study. A computer-generated software will randomly assign the numbers 1 to 80 into either group 1 or 2.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on previous studies using curcumin, we are predicting an effect size of 0.6. Based on this, a total sample size of 72 is required. This gives an 80% chance of finding an effect at a statistical significance of 0.05. In this study, we will be recruiting 80 participants, which should give us a suitable power to find an effect, even after dropouts.

Pre and post analyses will be conducted to determine changes in the following:
1. Gastrointestinal Symptom Rating Scale (GSRS) (total and subscale scores reflux, abdominal pain, indigestion, diarrhoea, and constipation)
2. Intestinal microbial diversity and bacterial compositions
3. Small Intestinal Bowel Overgrowth (SIBO)
4. Depression, Anxiety, and Stress Scale (DASS-21) (total and subscale scores)
5. Short Form-36 (SF-36) subscale scores

Comparisons will be made between the two conditions to determine if changes are significantly different.

These analyses will be conducted via a repeated-measures analysis of variance via SPSS

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/09/2019
Actual
6/09/2019
Date of last participant enrolment
Anticipated
31/01/2020
Actual
20/12/2019
Date of last data collection
Anticipated
27/03/2020
Actual
27/02/2020
Sample size
Target
80
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 303538 0
Commercial sector/Industry
Name [1] 303538 0
DolCas Biotech, LLC
Country [1] 303538 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
38 Arnisdale Rd Duncraig WA 6023
Country
Australia
Secondary sponsor category [1] 303607 0
None
Name [1] 303607 0
Address [1] 303607 0
Country [1] 303607 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304066 0
National Institute of Integrative Medicine (NIIM)
Ethics committee address [1] 304066 0
Ethics committee country [1] 304066 0
Australia
Date submitted for ethics approval [1] 304066 0
25/06/2019
Approval date [1] 304066 0
25/08/2019
Ethics approval number [1] 304066 0
0056E_2019

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

Contacts
Principal investigator
Name 95702 0
Dr Adrian Lopresti
Address 95702 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 95702 0
Australia
Phone 95702 0
+61894487376
Fax 95702 0
+61894478217
Email 95702 0
[email protected]
Contact person for public queries
Name 95703 0
Adrian Lopresti
Address 95703 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 95703 0
Australia
Phone 95703 0
+61894487376
Fax 95703 0
+61894478217
Email 95703 0
[email protected]
Contact person for scientific queries
Name 95704 0
Adrian Lopresti
Address 95704 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 95704 0
Australia
Phone 95704 0
+61894487376
Fax 95704 0
+61894478217
Email 95704 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by principal investigator by emailing the principal investigator [email protected]


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
EmbaseEfficacy of a curcumin extract (CurcugenTM) on gastrointestinal symptoms and intestinal microbiota in adults with self-reported digestive complaints: a randomised, double-blind, placebo-controlled study.2021https://dx.doi.org/10.1186/s12906-021-03220-6
N.B. These documents automatically identified may not have been verified by the study sponsor.