Trials / Completed
CompletedNCT03568513
Effect of Curcumin on Gut Microbiota in IBS
Effect of Curcumin Food Supplement on Gut Microbiota in Children With Irritable Bowel Syndrome
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Medical College of Wisconsin · Academic / Other
- Sex
- All
- Age
- 10 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DIETARY_SUPPLEMENT | 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. |
Timeline
- Start date
- 2018-08-01
- Primary completion
- 2020-01-02
- Completion
- 2020-01-02
- First posted
- 2018-06-26
- Last updated
- 2021-02-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03568513. Inclusion in this directory is not an endorsement.