SIBO & SIFO After Colectomy

NCT03216239 | Completed

• 1 other identifier: 659642
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Small Intestinal Bacterial Overgrowth; Small Intestinal Fungal Overgrowth; Colectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Response to treatment with antibiotics and antifungals

  4-5 years

Study Arms (2)

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,

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Augusta University: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Director of Neurogastroenterology/Motility

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 13, 2017
• Study Start: February 24, 2015
• Primary Completion: February 26, 2016
• Study Completion: February 26, 2016
• Last Updated: June 27, 2018

Record last verified: 2018-06