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OpenTrials
Completed

NCT Number: NCT03216239

SIBO & SIFO After Colectomy

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).

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Key information

Conditions

Small Intestinal Bacterial Overgrowth Colectomy Small Intestinal Fungal Overgrowth

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of SIBO/SIFO

    Time frame: 4-5 years

    Patients with unexplained GI symptoms following colectomy and to compare this with a control group of patients with similar symptoms but without previous colectomy.

Secondary outcomes

  1. Response to treatment with antibiotics and antifungals

    Time frame: 4-5 years

    Secondary aim was to assess the response to treatment with antibiotics and antifungals in colectomy patiens with SIBO/SIFO

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 13, 2017
Registry last updated
Jun 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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