Effect of Curcumin on Gut Microbiota in IBS

Medical College of Wisconsin

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Dietary Supplement: Curcumin; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03568513

UL1TR001436 (U.S. NIH Grant/Contract)

1120142

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

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.

Treatment:

Dietary Supplement: Curcumin

Placebo

Placebo Comparator group

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.

Treatment:

Dietary Supplement: Placebo