Small Intestinal Bacterial OvergrowthNCT03216239
SIBO & SIFO After Colectomy
An observational study of Small Intestinal Bacterial Overgrowth and Small Intestinal Fungal Overgrowth, run by Augusta University.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Intestinal Bacterial Overgrowth, Small Intestinal Fungal Overgrowth, Colectomy
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 24 Feb 2015to 26 Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-5 years
Secondary outcomes (1)
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
Measured: 4-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start24 Feb 2015
- Primary completion26 Feb 2016
- Study completion26 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestinal Bacterial OvergrowthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satish Rao, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216239
- Sponsor's protocol ID
- 659642
- Status last verified
- Jun 2018
- First submitted
- 11 Jul 2017
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Colectomy Predispose to Small Intestinal Bacterial (SIBO) and Fungal Overgrowth (SIFO)
- ClinicalTrials.gov ID
- NCT03216239
- Acronym / sponsor ID
- 659642
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 24 Feb 2015 (actual)
- Primary completion
- 26 Feb 2016 (actual)
- Study completion
- 26 Feb 2016 (actual)
- First posted
- 13 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Response to treatment with antibiotics and antifungals
Time frame: 4-5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Intestinal Bacterial Overgrowth and Small Intestinal Fungal Overgrowth, run by Augusta University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of SIBO/SIFO (time frame: 4-5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.