Small Intestine ProblemMESIBONCT04057560
Metabolomics in Small Intestinal Bacterial Overgrowth
An observational study of Small Intestine Problem, run by United Lincolnshire Hospitals NHS Trust.
Trial summary
Small intestinal bacterial overgrowth (SIBO) is a condition where a person's own good and useful germs, live in parts of the bowel where there should not be any germs. It may cause difficult tummy and bowel symptoms in a wide variety of patient groups. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Small Intestine Problem
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Sep 2020
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: All patients who are referred to Lincoln County Hospital for assessment of chronic diarrhoea will be considered eligible. They will be further assessed in a gastroenterology clinic using the inclusion and exclusion criteria
Who may be able to join
- Adults aged ≥ 18 and ≤ 50
- Absence of red flag symptoms i.e. unexplained weight loss, a palpable mass, unexplained iron deficiency anaemia or rectal bleeding
- GI symptoms which are due to possible SIBO
- Capacity to give informed consent
Who cannot join
- Presence of red flag symptoms (specified above in inclusion criteria)
- Previous GI surgery including cholecystectomy (except appendicectomy, inguinal/femoral hernia repair or Caesarean sections)
- Past history of inflammatory bowel disease, coeliac disease or pancreatic disease
- Past history of cancer (except basal cell carcinoma)
- Female patients who are pregnant
- Inability to adequately understand verbal or written information
Show all 9Show fewer
- Inability or unwillingness to give informed consent
- Unwilling to consider taking antibiotics to treat SIBO
- Incapacity to comply with the demands of the study
Trial locations and contacts
No sites are listed yet.
About this study
Small intestinal bacterial overgrowth (SIBO) is a condition where a person's own good and useful germs, live in parts of the bowel where there should not be any germs. It may cause difficult tummy and bowel symptoms in a wide variety of patient groups. Increasing evidence suggests that sometimes small intestinal bacterial overgrowth can also trigger or worsen diseases which do not have any bowel symptoms at all.
It is hugely under-diagnosed in clinical practice. Part of the reason for this is that current available diagnostic tests - culture of fluid sampled from the upper part of the gastrointestinal tract or breath testing, are complicated to do, difficult for the patient, and are not completely accurate. Therefore, the potential for a simple, more accurate test to revolutionise the diagnosis and aid with the treatment of this condition is immense.
Read more
When it is accurately diagnosed, treatment with antibiotics can cure the patient of their tummy or bowel symptoms.
Based on previous research the investigators have conducted, it is believed that it might be possible to diagnose this condition in a simpler and more accurate way by examining urine samples. This study will also investigate whether the condition could be diagnosed more accurately using a blood test, a different sort of breath test or using a mouth swab.
The proposed study will be conducted at Lincoln County Hospital, in collaboration with Joseph Banks Laboratory at the University of Lincoln. Additional urine, blood, swab and breath samples from patients with and without small intestinal bacterial overgrowth, before and after antibiotic treatment to identify specific molecular markers in urine, blood and saliva samples which diagnosis small intestinal bacterial overgrowth accurately.
- Conditions
- Small Intestine Problem
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 |
|---|---|---|
| SIBO Group | Not described | |
| Control Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomic patterns in the biological samples collected from patients with SIBO
Metabolomic patterns in the biological samples collected from patients with SIBO
Measured: 12 months
Metabolomic patterns in the biological samples collected from patients who do and do not report an improvement in clinical symptoms following antibiotic treatment
Metabolomic patterns in the biological samples collected from patients who do and do not report an improvement in clinical symptoms following antibiotic treatment
Measured: 12 moths
Secondary outcomes (3)
Changes in total Gastrointestinal Symptom Rating Scale scores in patients with SIBO before antibiotic treatment and following successful eradication of SIBO.
The Gastrointestinal Symptom Rating Scale is a self-assessed questionnaire consistsing of 32 individual gastrointestinal symptoms which are categorised into olfactory, upper GI, lower GI and anorectal subgroups. Each of the 32 items has a score of 0-3 (a high score represent a higher severity of the symptom). All 32 subscores will add up to give a total score.
Measured: 12 months
Changes in stool types in patients with SIBO before antibiotic treatment and following successful eradication of SIBO.
This will be based on Bristol Stool Chart Type 1 to 7 stool (Type 1 is hard, lumpy stool and Type 7 is loose, watery stool)
Measured: 12 months
Changes in improvement in quality of life in patients with SIBO before antibiotic treatment and following successful eradication of SIBO.
Quality of life of patients will be assessed using a visual analogue scale of 1 to 10 (higher values represent a better quality of life)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study startNov 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestine ProblemStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Lincolnshire Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057560
- Sponsor's protocol ID
- IRAS 255049
- Acronym
- MESIBO
- Status last verified
- Oct 2019
- First submitted
- 23 Jul 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics in Small Intestinal Bacterial Overgrowth
- ClinicalTrials.gov ID
- NCT04057560
- Acronym / sponsor ID
- MESIBO / IRAS 255049
- Conditions
- Small Intestine Problem
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- United Lincolnshire Hospitals NHS TrustUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 15 Aug 2019 (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.
Small intestinal bacterial overgrowth (SIBO) is a condition where a person's own good and useful germs, live in parts of the bowel where there should not be any germs. It may cause difficult tummy and bowel symptoms in a wide variety of patient groups. Increasing evidence suggests that sometimes small intestinal bacterial overgrowth can also trigger or worsen diseases which do not have any bowel symptoms at all.
It is hugely under-diagnosed in clinical practice. Part of the reason for this is that current available diagnostic tests - culture of fluid sampled from the upper part of the gastrointestinal tract or breath testing, are complicated to do, difficult for the patient, and are not completely accurate. Therefore, the potential for a simple, more accurate test to revolutionise the diagnosis and aid with the treatment of this condition is immense.
When it is accurately diagnosed, treatment with antibiotics can cure the patient of their tummy or bowel symptoms.
Based on previous research the investigators have conducted, it is believed that it might be possible to diagnose this condition in a simpler and more accurate way by examining urine samples. This study will also investigate whether the condition could be diagnosed more accurately using a blood test, a different sort of breath test or using a mouth swab.
The proposed study will be conducted at Lincoln County Hospital, in collaboration with Joseph Banks Laboratory at the University of Lincoln. Additional urine, blood, swab and breath samples from patients with and without small intestinal bacterial overgrowth, before and after antibiotic treatment to identify specific molecular markers in urine, blood and saliva samples which diagnosis small intestinal bacterial overgrowth accurately.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIBO Group | – | – |
| Control Group | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients who are referred to Lincoln County Hospital for assessment of chronic diarrhoea will be considered eligible. They will be further assessed in a gastroenterology clinic using the inclusion and exclusion criteria
Key inclusion criteria (4 listed)
- Adults aged ≥ 18 and ≤ 50
- Absence of red flag symptoms i.e. unexplained weight loss, a palpable mass, unexplained iron deficiency anaemia or rectal bleeding
- GI symptoms which are due to possible SIBO
- Capacity to give informed consent
Key exclusion criteria (9 listed)
- Presence of red flag symptoms (specified above in inclusion criteria)
- Previous GI surgery including cholecystectomy (except appendicectomy, inguinal/femoral hernia repair or Caesarean sections)
- Past history of inflammatory bowel disease, coeliac disease or pancreatic disease
- Past history of cancer (except basal cell carcinoma)
- Female patients who are pregnant
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
Metabolomic patterns in the biological samples collected from patients with SIBO
Time frame: 12 months
Metabolomic patterns in the biological samples collected from patients with SIBO
Metabolomic patterns in the biological samples collected from patients who do and do not report an improvement in clinical symptoms following antibiotic treatment
Time frame: 12 moths
Metabolomic patterns in the biological samples collected from patients who do and do not report an improvement in clinical symptoms following antibiotic treatment
3 secondary outcomes
Changes in total Gastrointestinal Symptom Rating Scale scores in patients with SIBO before antibiotic treatment and following successful eradication of SIBO.
Time frame: 12 months
Changes in stool types in patients with SIBO before antibiotic treatment and following successful eradication of SIBO.
Time frame: 12 months
Changes in improvement in quality of life in patients with SIBO before antibiotic treatment and following successful eradication of SIBO.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Intestine Problem, run by United Lincolnshire Hospitals NHS Trust.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 29 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dennis Poon (07402687395, dpoon@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomic patterns in the biological samples collected from patients with SIBO (time frame: 12 months). The study lists 2 primary outcomes in all. 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 29 Oct 2019.