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Completed

NCT Number: NCT03568513

Effect of Curcumin on Gut Microbiota in IBS

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Gastrointestinal Diseases Genetic Diseases, Inborn Ichthyosis Ichthyosis Bullosa of Siemens Infant, Newborn, Diseases Intestinal Diseases Keratosis Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Curcumin

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

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.

Primary outcomes

  1. Alteration in Gut Microbiota

    Time frame: 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 outcomes

  1. Comparison of GI Symptoms

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Clinical & Translational Science Institute of Southeast Wisconsin

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 26, 2018
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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