ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1238-9393

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Gastrointestinal complaints

Condition category

Condition code

Oral and Gastrointestinal

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]

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]

Gastrointestinal symptoms assessed by total score on Gastrointestinal Symptom Rating Scale (GSRS)

Timepoint [1]

Days 0, 30, and 60 (primary timepoint)

Primary outcome [2]

Taxonomic change in Intestinal bacteria as assessed by stool sample and 16S rRNA gene sequencing

Timepoint [2]

Days 0 and 60 (primary timepoint)

Secondary outcome [1]

Small Intestinal Bowel Overgrowth (SIBO) as assessed by SIBO lactulose breath test

Timepoint [1]

Days 0 and 60

Secondary outcome [2]

Mood quality assessed by total score on Depression, Anxiety, and Stress Scale (DASS-21)

Timepoint [2]

Days 0, 30 and 60

Secondary outcome [3]

General health assessed by Short-Form-36 (SF-36)

Timepoint [3]

Days 0, 30, and 60

Secondary outcome [4]

Pain assessed by Short-Form-36 (SF-36)

Timepoint [4]

Days 0, 30, and 60

Secondary outcome [5]

Abdominal pain assessed by Gastrointestinal Symptom Rating Scale (GSRS)

Timepoint [5]

Days 0, 30, and 60

Secondary outcome [6]

Reflux symptoms assessed by Gastrointestinal Symptom Rating Scale (GSRS)

Timepoint [6]

Days 0, 30, and 60

Secondary outcome [7]

Indigestion symptoms assessed by Gastrointestinal Symptom Rating Scale (GSRS)

Timepoint [7]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

DolCas Biotech, LLC

Address [1]

9 Lenel Road,
Landing, NJ 07850, USA

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

National Institute of Integrative Medicine (NIIM)

Ethics committee address [1]

21 Burwood Rd
Hawthorn VIC 3122

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/06/2019

Approval date [1]

25/08/2019

Ethics approval number [1]

0056E_2019

Summary

Brief summary

In this randomised, double-blind, placebo-controlled study, 80 adults who are currently experiencing digestive complaints will be randomly assigned to receive capsules containing either a curcumin extract (500mg a day) or placebo for 60 days. We will assess change in digestive symptoms, intestinal bacteria, general mood, and overall quality of life.

Trial website

https://clinicalresearch.com.au/cra-studies/curcumin-gut-study/

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Adrian Lopresti

Address

Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023

Country

Australia

Phone

+61894487376

Fax

+61894478217

adrian@clinicalresearch.com.au

Contact person for public queries

Name

Adrian Lopresti

Address

Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023

Country

Australia

Phone

+61894487376

Fax

+61894478217

adrian@clinicalresearch.com.au

Contact person for scientific queries

Name

Adrian Lopresti

Address

Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023

Country

Australia

Phone

+61894487376

Fax

+61894478217

adrian@clinicalresearch.com.au

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 adrian@clinicalresearch.com.au

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

Source	Title	Year of Publication	DOI
Embase	Efficacy 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.	2021	https://dx.doi.org/10.1186/s12906-021-03220-6

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically