Effect of Curcumin on Gut Microbiota in IBS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03568513|
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : May 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Dietary Supplement: Curcumin Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Curcumin Food Supplement on Gut Microbiota in Children With Irritable Bowel Syndrome|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2028|
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
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.
Placebo Comparator: Placebo
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 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 [ Time Frame: 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
- Comparison of GI Symptoms [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568513
|Contact: Manu Sood, MDemail@example.com|
|United States, Wisconsin|
|Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Manu Sood, MD 414-266-3690 firstname.lastname@example.org|
|Sub-Investigator: Prasanna Kapavarapu, MD|
|Sub-Investigator: Katja Kovacic, MD|
|Sub-Investigator: Alan Silverman, PhD|
|Sub-Investigator: Danielle Schneider, RD|
|Sub-Investigator: Cassandra Walia, RD|
|Sub-Investigator: Nita Salzman, MD, PhD|
|Sub-Investigator: Pippa Simpson, PhD|
|Principal Investigator:||Manu Sood, MD||Medical College of Wisconsin|