SIBO & SIFO After Colectomy

Small Intestinal Bacterial Overgrowth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03216239
• Other study ID #: 659642
• Status: Completed
• Start date: February 24, 2015
• Est. completion date: February 26, 2016

Study information

• Verified date: June 2018
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 26, 2016
• Est. primary completion date: February 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colectomy
• Small Intestinal Bacterial Overgrowth
• Small Intestinal Fungal Overgrowth

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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