SIBO & SIFO After Colectomy

NCT ID: NCT03216239

Last Updated: 2018-06-27

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

2015-02-24

Study Completion Date

2016-02-26

Brief Summary

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After subtotal colectomy, 40% of patients report abdominal pain, gas and diarrhea, and poor quality of life; whose etiology is unknown. The investigators determined whether small intestinal bacterial (SIBO or fungal overgrowth SIFO) could cause these sympotoms (\> 1 year).

Detailed Description

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Conditions

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Small Intestinal Bacterial Overgrowth Small Intestinal Fungal Overgrowth Colectomy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Colectomy Group

Mean age 52.3 years (range:20-85), 82% females, and a mean duration of symptoms of 79.9 months in the colectomy group. The indication for colectomy was constipation (36%), diverticular disease (8%), bowel obstruction (8%), colorectal carcinoma (8%), colon polyps (6%), and other (34%).

No interventions assigned to this group

Control Group

Mean age of 49.9 years (range 18-88), 76% females, and mean duration of symptoms 77.6 months,

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

patients who were referred to a specialist motility center over 4 year period with:

* Unexplained gastrointestinal symptoms such as gas, bloating, belching, diarrhea, and abdominal discomfort
* history of colectomy
* patients with no history of colectomy
* patients included who had normal: upper endoscopy, colonoscopy, computerized abdominal tomography scan, and normal hematology, biochemical profiles, tissue transglutaminase antibody, thyroid stimulating hormone, and normal right upper quadrant ultrasound scan.
* patients with glucose breath test and/or duodenal aspirate

Exclusion Criteria

* patients with upper gut or small bowel surgery
* Patients who were hospitalized or with serious cardiac or pulmonary or neurologic comorbidities
* Patients with intestinal strictures or known intestinal motility disorders such as scleroderma or pseudo-obstruction syndrome
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Satish Rao

Professor of Medicine, Director of Neurogastroenterology/Motility

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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659642

Identifier Type: -

Identifier Source: org_study_id

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