An interventional study of Curcumin and Placebo in Irritable Bowel Syndrome, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-02-21.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Treatment
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.
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 4 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
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Exclusion Criteria:
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
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
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.
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.
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
Time frame: 8 weeks
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.
Time frame: 8 weeks
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Medical College of Wisconsin