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Effect of Curcumin on Gut Microbiota in IBS

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Curcumin
Placebo
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Curcumin, IBS and microbiota

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
April 26, 2018
Last Updated
February 18, 2021
Sponsor
Medical College of Wisconsin
Collaborators
Clinical & Translational Science Institute of Southeast Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT03568513
Brief Title
Effect of Curcumin on Gut Microbiota in IBS
Official Title
Effect of Curcumin Food Supplement on Gut Microbiota in Children With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
January 2, 2020 (Actual)
Study Completion Date
January 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Clinical & Translational Science Institute of Southeast Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Curcumin, IBS and microbiota

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Curcumin
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Alteration in Gut Microbiota
Description
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
Secondary Outcome Measure Information:
Title
Comparison of GI Symptoms
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manu Sood, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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Effect of Curcumin on Gut Microbiota in IBS

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