NCT03568513

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2020

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

1.4 years

First QC Date

April 26, 2018

Last Update Submit

February 18, 2021

Conditions

Irritable Bowel Syndrome

Keywords

CurcuminIBS and microbiota

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Comparison of GI Symptoms

    8 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

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.

Dietary Supplement: Curcumin

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

CurcuminDIETARY_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.

Treatment
PlaceboDIETARY_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.

Placebo

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • to 18 years old
  • Fulfill the Rome IV criteria for diarrhea predominant IBS
  • English speaking
  • Able to swallow curcumin/placebo capsules

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Irritable Bowel SyndromeIchthyosis Bullosa of Siemens

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesIchthyosisSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornInfant, Newborn, DiseasesKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Manu Sood, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 26, 2018

First Posted

June 26, 2018

Study Start

August 1, 2018

Primary Completion

January 2, 2020

Study Completion

January 2, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

US(1)