Fecal Metabolome and the Intestinal Microbiota in Irritable Bowel Syndrome

NCT ID: NCT02981888

Last Updated: 2024-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-01

Study Completion Date

2023-04-27

Brief Summary

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The purpose of this study is to find out the relationship between the bile acids, fatty acids (fatty acids are part of the diet) and bacteria that are present in the intestines.

Detailed Description

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There is emerging evidence that alterations in bile acids and SCFA associated with IBS could be associated with changes in the gut microbiota. In addition to modulating levels of intraluminal organic acids, it has been hypothesized that gut microbiota may alter local immune responses, modulate visceral pain responses, and impair gut barrier function.

Our overall goal is to investigate the relationship between fecal bile acids, SCFA and the gut microbiota in IBS. Results of this pilot study could reveal insights into the interplay of the gut microbiota and small molecule mediators of IBS to suggest targeted clinical strategies for improved diagnosis and management of this important syndrome.

AIM 1: Test the hypothesis that fecal organic acids (SFCA and bile acids) and fecal microbiota play an important role in IBS.

AIM 2: Test the hypothesis that there is association between colonic transit and fecal microbiota in IBS

Conditions

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IBS

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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IBS-C

all patients with IBS -C will undergo an abdominal x-ray for assessment of colonic transit

X-Ray

Intervention Type RADIATION

X-ray of the abdomen will be performed to assess colonic transit

IBS-D

all patients with IBS-D will undergo an abdominal x-ray for assessment of colonic transit

X-Ray

Intervention Type RADIATION

X-ray of the abdomen will be performed to assess colonic transit

heathy control

all healthy controls will undergo an abdominal x-ray for assessment of colonic transit

X-Ray

Intervention Type RADIATION

X-ray of the abdomen will be performed to assess colonic transit

Interventions

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X-Ray

X-ray of the abdomen will be performed to assess colonic transit

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Patients with IBS, ages 18-65 fulfilling Rome IV criteria and asymptomatic controls with no prior history of GI disease or symptoms.
* Participants should be on a stable and consistent diet regimen and should not be following an extreme diet intervention such as gluten-free or a low FODMAP diet at the time of study participation.

Exclusion Criteria

* Participants with microscopic/lymphocytic/collagenous colitis, inflammatory bowel disease, celiac disease, visceral cancer, chronic infectious disease, immunodeficiency, uncontrolled thyroid disease, history of liver disease or history of elevated AST/ALT \> 2.0x the upper limit of normal
* Prior radiation therapy of the abdomen or abdominal surgeries with the exception of appendectomy or cholecystectomy \> 6 months prior to study initiation
* Ingestion of any prescription, over the counter, or herbal medications which can affect GI transit or study interpretation (e.g. opioids, narcotics, anticholinergics, norepinephrine reuptake inhibitors, nonsteroidal anti-inflammatory drugs, COX-2 inhibitors, bile acid sequestrants) within 6 months of study initiation for asymptomatic volunteers or within 2 days before study initiation for IBS patients
* Any females who are pregnant or trying to become pregnant or breast-feeding
* Antibiotic usage within 3 months prior to study participation
* Prebiotic or probiotic usage within the 2 weeks prior to study initiation
* Use of tobacco products within the past 6 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Huiping Xu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Shin, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Indiana University Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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Waseem MR, Shin A, Siwiec R, James-Stevenson T, Bohm M, Rogers N, Wo J, Waseem L, Gupta A, Jarrett M, Kadariya J, Xu H. Associations of Fecal Short Chain Fatty Acids With Colonic Transit, Fecal Bile Acid, and Food Intake in Irritable Bowel Syndrome. Clin Transl Gastroenterol. 2023 Jan 1;14(1):e00541. doi: 10.14309/ctg.0000000000000541.

Reference Type DERIVED
PMID: 36227781 (View on PubMed)

Other Identifiers

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1606244063

Identifier Type: -

Identifier Source: org_study_id

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