SIBO & SIFO After Colectomy

Does Colectomy Predispose to Small Intestinal Bacterial (SIBO) and Fungal Overgrowth (SIFO)

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).

Study Overview

• Status: Completed
• Conditions: Colectomy; Small Intestinal Bacterial Overgrowth; Small Intestinal Fungal Overgrowth

• Study Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients of the Digestive Health Center over a 4 year period who have been seen by the motility specialists for unexplained gastrointestinal symptoms.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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%).
Control Group; Mean age of 49.9 years (range 18-88), 76% females, and mean duration of symptoms 77.6 months,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of SIBO/SIFO	Patients with unexplained GI symptoms following colectomy and to compare this with a control group of patients with similar symptoms but without previous colectomy.	4-5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to treatment with antibiotics and antifungals	Secondary aim was to assess the response to treatment with antibiotics and antifungals in colectomy patiens with SIBO/SIFO	4-5 years

Collaborators and Investigators

• Sponsor: Augusta University

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2015
• Primary Completion (Actual): February 26, 2016
• Study Completion (Actual): February 26, 2016

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: July 11, 2017
• First Posted (Actual): July 13, 2017

Study Record Updates

• Last Update Posted (Actual): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 659642

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No