Metabolomics in Small Intestinal Bacterial Overgrowth (MESIBO)

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 Overview

• Status: Unknown
• Conditions: Small Intestine Problem

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Dennis Poon; Phone Number: 07402687395; Email: dpoon@nhs.net
• Study Contact Backup: Name: Jervoise Andreyev; Phone Number: 01522573672; Email: j@andreyev.demon.co.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

1. Adults aged ≥ 18 and ≤ 50
2. Absence of red flag symptoms i.e. unexplained weight loss, a palpable mass, unexplained iron deficiency anaemia or rectal bleeding
3. GI symptoms which are due to possible SIBO
4. Capacity to give informed consent

Exclusion Criteria:

1. Presence of red flag symptoms (specified above in inclusion criteria)
2. Previous GI surgery including cholecystectomy (except appendicectomy, inguinal/femoral hernia repair or Caesarean sections)
3. Past history of inflammatory bowel disease, coeliac disease or pancreatic disease
4. Past history of cancer (except basal cell carcinoma)
5. Female patients who are pregnant
6. Inability to adequately understand verbal or written information
7. Inability or unwillingness to give informed consent
8. Unwilling to consider taking antibiotics to treat SIBO
9. Incapacity to comply with the demands of the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control Group
SIBO Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolomic patterns in the biological samples collected from patients with SIBO	Metabolomic patterns in the biological samples collected from patients with SIBO	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	12 moths

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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)	12 months

Collaborators and Investigators

• Sponsor: United Lincolnshire Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 29, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IRAS 255049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No