Effect of Curcumin on Gut Microbiota in IBS

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Curcumin

• Registration Number: NCT03568513
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-06-15
• Study First Posted: 2018-06-26
• Study Start: 2018-08-01
• Primary Completion: 2020-01-02
• Study Completion: 2020-01-02
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Treatment	Curcumin	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.

Primary Outcome Measures

Name	Time	Method
Alteration in Gut Microbiota	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

Name	Time	Method
Comparison of GI Symptoms	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.

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States