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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03216239
Other study ID # 659642
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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