Effect of Curcumin on Gut Microbiota in IBS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Curcumin Food Supplement on Gut Microbiota in Children With Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: Curcumin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Patients in the treatment arm with weight between 35 kg to 50 kg will receive 50 mg capsule of curcumin twice a day (maximum dose 2.8 mg/kg/day, which is within the GRAS approved dose) and those over 50 kg in weight will receive three curcumin capsules a day (maximum dose 3 mg/kg/day, within GRAS recommended dose). Study duration will be 8 weeks. | Dietary Supplement: Curcumin<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Patients in the placebo arm will receive a capsule which has similar size, shape and color of the curcumin capsule. The placebo capsule will contain inert food powder. Study duration will be 8 weeks. | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alteration in Gut Microbiota | 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 | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of GI Symptoms | 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Curcumin, IBS and microbiota