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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
Sponsor:
Collaborator:
Clinical & Translational Science Institute of Southeast Wisconsin
Information provided by (Responsible Party):
Manu Sood, Medical College of Wisconsin

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: Curcumin Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: Treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Manu Sood, MD 414-266-3690 msood@mcw.edu

Locations
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United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Manu Sood, MD    414-266-3690    msood@mcw.edu   
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         
Sponsors and Collaborators
Medical College of Wisconsin
Clinical & Translational Science Institute of Southeast Wisconsin
Investigators
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Principal Investigator: Manu Sood, MD Medical College of Wisconsin
  Study Documents (Full-Text)

Documents provided by Manu Sood, Medical College of Wisconsin:
Informed Consent Form  [PDF] January 12, 2019


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Responsible Party: Manu Sood, Principal Investigator, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03568513     History of Changes
Other Study ID Numbers: 1120142
UL1TR001436 ( U.S. NIH Grant/Contract )
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Manu Sood, Medical College of Wisconsin:
Curcumin
IBS and microbiota

Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action