Effect of Curcumin on Gut Microbiota in IBS

• ClinicalTrials.gov Identifier: NCT03568513
• Recruitment Status: Completed
• First Posted: June 26, 2018
• Last Update Posted: February 21, 2021
• Sponsor: Medical College of Wisconsin
• Collaborator: Clinical & Translational Science Institute of Southeast Wisconsin
• Information provided by (Responsible Party): Manu Sood, Medical College of Wisconsin

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4 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
• Actual Primary Completion Date: January 2, 2020
• Actual Study Completion Date: January 2, 2020

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Wisconsin

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Medical College of Wisconsin

Clinical & Translational Science Institute of Southeast Wisconsin

Investigators

• 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] September 2, 2020

More Information

• Responsible Party: Manu Sood, Principal Investigator, Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT03568513
• Other Study ID Numbers: 1120142; UL1TR001436 ( U.S. NIH Grant/Contract )
• First Posted: June 26, 2018
• Last Update Posted: February 21, 2021
• Last Verified: February 2021

• 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:

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