Curcumin for the Treatment of Digestive Complaints in Adults

Not Applicable

Completed

• Conditions: Gastrointestinal complaints; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12619001236189
• Lead Sponsor: Clinical Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-06
• Study Completion: 2020-02-27
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 79

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms assessed by total score on Gastrointestinal Symptom Rating Scale (GSRS)[Days 0, 30, and 60 (primary timepoint)];Taxonomic change in Intestinal bacteria as assessed by stool sample and 16S rRNA gene sequencing[Days 0 and 60 (primary timepoint)]

Secondary Outcome Measures

Name	Time	Method
Small Intestinal Bowel Overgrowth (SIBO) as assessed by SIBO lactulose breath test[Days 0 and 60];Mood quality assessed by total score on Depression, Anxiety, and Stress Scale (DASS-21)[Days 0, 30 and 60];General health assessed by Short-Form-36 (SF-36)[Days 0, 30, and 60];Pain assessed by Short-Form-36 (SF-36)[Days 0, 30, and 60];Abdominal pain assessed by Gastrointestinal Symptom Rating Scale (GSRS)[Days 0, 30, and 60];Reflux symptoms assessed by Gastrointestinal Symptom Rating Scale (GSRS)[Days 0, 30, and 60];Indigestion symptoms assessed by Gastrointestinal Symptom Rating Scale (GSRS)[Days 0, 30, and 60]