Irritable Bowel Syndrome
Conditions
Keywords
Curcumin, IBS and microbiota
Brief summary
To evaluate the effect of curcumin food supplement on gut microbiota of children with irritable bowel syndrome (IBS) and to review any correlation between the changes in the microbiota with symptoms.
Detailed description
This is a prospective, placebo-controlled, double blinded, randomized control trial. This study will evaluate the effect of curcumin food supplement on gut microbiota of children with irritable bowel syndrome. Curcumin is a commonly used spice in Asian cooking and has a very good safety profile. Developing preparation of this compound for targeted delivery in the GI tract would provide a novel way to treat common FGID. This study will provide preliminary data for future studies to evaluate the role of gut microbiota in the pathophysiology of pain predominant FGID and how food supplements can be used to manipulate the microbiota.
Interventions
DIETARY_SUPPLEMENTCurcumin
The curcumin food supplement will be administered in the form of capsules. Participants in the treatment arm will take 50 mg twice or three times a day, depending on their body weight. Participants will take the curcumin capsules for eight weeks.
DIETARY_SUPPLEMENTPlacebo
The placebo will be administered in the form of capsules. Participants in the placebo arm will take a capsule twice or three times a day, depending on their body weight. Participants will take the placebo capsules for eight weeks. The placebo capsule will be similar in size, shape and color to the curcumin capsule and they will contain inert food powder.
Sponsors
Clinical & Translational Science Institute of Southeast Wisconsin
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 10 to 18 years old * Fulfill the Rome IV criteria for diarrhea predominant IBS * English speaking * Able to swallow curcumin/placebo capsules
Exclusion criteria
* Weigh less than 35 kg * On any form of dietary restrictions * Taken probiotics one month before enrollment * Antibiotic treatment one month before enrollment * IBD * Celiac disease * Peptic ulcer disease * H. Pylori gastritis * Abnormality of gastrointestinal tract * Previous abnormal endoscope * Previous abdominal surgeries * Gall stones * Biliary tract obstructions * Liver pathologies * Liver failure * Active GI infection * Positive stool cultures * Drug or alcohol abuse * Concomitant immunological/hematological/neoplastic/heart/ renal/pulmonary condition * Any other medical condition or taking any form of drug(s) which can explain the current symptoms * Take oral or intravenous drugs which could have potential drug interaction with curcumin * Lactating or pregnant or planning to become pregnant * Developmental delay * Parents that are developmentally delayed * Have a diet high in curcumin/turmeric
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alteration in Gut Microbiota | 8 weeks | To study the alteration in gut microbiota with 8-week curcumin dietary supplementation in children with IBS between the ages of 10 yrs to 18 yrs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of GI Symptoms | 8 weeks | To compare the GI symptoms at baseline and after 8-weeks of curcumin dietary supplementation we will be using a previously validated Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) questionnaire (Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther 1997; 11(2): 395-402). This questionnaire measures symptom severity and includes a scale of none to very severe or very happy to very unhappy or not at all to completely as well as often/occasionally/never. The maximum achievable score is 500 and mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and \>300 respectively. Higher scores means worse outcome and vice versa. At the end of the 8-weeks curcumin supplementation any absolute or relative decrease in the total score in comparison to baseline will considered as improvement in outcome. |
Countries
United States
Outcome results
None listed