Trial record 19 of 158 for:
Enzyme | curcumin
Effect of Curcumin on Gut Microbiota in IBS
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ClinicalTrials.gov Identifier: NCT03568513 |
Recruitment Status :
Recruiting
First Posted : June 25, 2018
Last Update Posted : May 21, 2019
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Sponsor:
Medical College of Wisconsin
Collaborator:
Clinical & Translational Science Institute of Southeast Wisconsin
Information provided by (Responsible Party):
Manu Sood, Medical College of Wisconsin
Tracking Information | |||||
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First Submitted Date ICMJE | April 26, 2018 | ||||
First Posted Date ICMJE | June 25, 2018 | ||||
Last Update Posted Date | May 21, 2019 | ||||
Actual Study Start Date ICMJE | August 1, 2018 | ||||
Estimated Primary Completion Date | March 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT03568513 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effect of Curcumin on Gut Microbiota in IBS | ||||
Official Title ICMJE | Effect of Curcumin Food Supplement on Gut Microbiota in Children With Irritable Bowel Syndrome | ||||
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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Irritable Bowel Syndrome | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
50 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 2028 | ||||
Estimated Primary Completion Date | March 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 10 Years to 18 Years (Child, Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03568513 | ||||
Other Study ID Numbers ICMJE | 1120142 UL1TR001436 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Manu Sood, Medical College of Wisconsin | ||||
Study Sponsor ICMJE | Medical College of Wisconsin | ||||
Collaborators ICMJE | Clinical & Translational Science Institute of Southeast Wisconsin | ||||
Investigators ICMJE |
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PRS Account | Medical College of Wisconsin | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |