Effect of Curcumin on Gut Microbiota in IBS

NCT ID: NCT03568513

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2020-01-02

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical & Translational Science Institute of Southeast Wisconsin

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Manu Sood

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manu Sood, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

UL1TR001436

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1120142

Identifier Type: -

Identifier Source: org_study_id