Effect of Curcumin on Gut Microbiota in IBS

Irritable Bowel Syndrome Clinical Trial

Official title:

Effect of Curcumin Food Supplement on Gut Microbiota in Children With Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03568513
• Other study ID #: 1120142
• Secondary ID: UL1TR001436
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: January 2, 2020

Study information

• Verified date: February 2021
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: January 2, 2020
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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
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.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Clinical & Translational Science Institute of Southeast Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 weeks
Secondary	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.	8 weeks