Comparing clinical symptoms and bacterial features in irritable bowel syndrome (IBS) patients with and without small intestine bacterial overgrowth (SIBO).

Comparing clinical symptoms and features of the microbiome and metabolome in diarrhoea predominant and mixed irritable bowel syndrome (IBS) patients with and without small intestine bacterial overgrowth (SIBO).

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12616001162404

Enrollment

114

Registered

2016-08-26

Start date

2016-04-19

Completion date

2017-06-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The data for this observational study comparing the clinical characteristics and features of the microbiome is being collected at the screening phase of ACTRN12616001149459 In 371306 participants with diarrhoea predominant IBS and mixed type IBS are being screened for small intestine bacterial overgrowth (SIBO). 75g of glucose in 200ml of water is being provided as the test substrate. Prior to adminisitration of the glucose solution and every 15 minutes after consuming the test substrate for 2 hours participants are providing a breath sample. The breath sample is being analysed for hydrogen and methane. For participants with a rise of => than 12 ppm in either gas from baseline are defined as haing SIBO. In this observational study we are aiming to see whether there is a diference in clinical characteristics and microbiome features between those with and without SIBO. Our hypothesis is that the clinical characteristics of those with and without SIBO will differ. Secondly we hypothesise that there will be differences in the products produced by the bacteria (detected in the urinary metabolome). Prior to attending the screening survey participants will complete 8 surveys on line and they will provide a stool and a urine sample. The questionnaires they will complete are a demographic questionnaire, a simple health questionnaire, the IBS symptom severity scoring system (Francis 1997), and IBS quality of life questionnaire (Drossman 1998). the physical activity adult questionnaire (Garriguet 2015), the hospital anxiety and depression index (Zigmond 1983) and a foods avoided questionnaire and the diet history questionnaire version 2 (http://epi.grants.cancer.gov/dhq2/). Faecal and urine samples will be stored at -80C until they are analysed. Faecal samples will be analysed for the bacteria present (in the colon) and urine samples will be analysed to see what the bacteria have been doing.

Interventions

Participants will be screened for small intestine bacterial overgrowth (SIBO) using a glucose breath test. Before consuming a 75g of glucose in 200ml of water the participants will provide a breath sample. They will then provide breath samples every 15 minutes for 2 hours. If they have a rise of >=12 ppm of either hydrogen or methane from baseline this will be diagnosed as SIBO. Participants will be seen for one 2 hour session with no follow for those without SIBO. Those with SIBO will be part

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Participants with IBS (D) or IBS (M) according to Rome III criteria who are fluent in English. Healthy controls are female and male, aged 18-65 with no gastrointestinal physiology and fluent in English.

Exclusion criteria

Organic gastrointestinal disease (e.g. coeliac, IBD), Diabetes, Serious neurological or respiratory conditions Previous gastrointestinal surgery (except appendectomy), Pancreatitis, Previous radiotherapy to the abdominal area or chemotherapy, Pregnancy and lactation, Antibiotics or probiotics within the last 6 weeks,

Outcome results