None listed
Conditions
Brief summary
Irritable bowel syndrome (IBS) is a common disorder affecting 5-15% of Australians. Recently the Gastroenterology department research team at Monash University have created a dietary management approached for the treatment of IBS. The dietary approach termed the low FODMAP diet restricts poorly absorbed carbohydrates. The term FODMAPs denotes fermentable, oligo-, di-, mono-saccharides and polyols. These carbohydrates are poorly absorbed in the small intestinal lumen and therefore travel to the large intestine where they are fermented by colonic bacteria to produce products of hydrogen, methane, carbon dioxide and short chain fatty acids. The dietary approach uses a restrictive phase followed by a re-introduction phase to assess individual tolerance to the various FODMAP subgroups. The dietary restrictions however can be difficult to maintain, especially among patients with other food intolerances or dislikes. This is particularly relevant to vegetarians and vegans as legumes, a major source of protein, is restricted during the low FODMAP diet. The types of carbohydrates in legumes are unable to be digested in the human small intestine as humans do not have the enzyme to break them down; they are therefore often a trigger of IBS symptoms. In the USA and Europe there are tablets on the market which contain alpha-galactosidase, an enzyme to break down the carbohydrate’s present in legumes. A few studies have been conducted to assess the enzyme use in healthy controls, but there is limited research using them in patients with IBS. The aim of this study is to evaluate if the alpha-galactosidase enzyme can reduce breath hydrogen and symptoms in IBS. We hypothesize that there will be a reduction in both hydrogen and symptoms with the use of the alpha-galactosidase enzyme.
Interventions
Breath hydrogen and symptoms will be measured on 3 different study arms. Each arm involves 3 days of consuming foods provided (low in FODMAPs but high in Galactooligosaccharides) plus an oral enzyme supplement. The food will be identical for each study arm. The food is low in FODMAPs meaning it does not contain foods classified as high FODMAP according to the Monash University low FODMAP diet with the exception of foods high in galactooligosaccharides. Types of foods high in galactooligosacchari
Breath hydrogen and symptoms will be measured on 3 different study arms. Each arm involves 3 days of consuming foods provided (low in FODMAPs but high in Galactooligosaccharides) plus an oral enzyme supplement. The food will be identical for each study arm. The food is low in FODMAPs meaning it does not contain foods classified as high FODMAP according to the Monash University low FODMAP diet with the exception of foods high in galactooligosaccharides. Types of foods high in galactooligosaccharides include nuts, legumes and lupin flakes which have been used in the study diet. The maximum total FODMAP content (mainly coming from the galactooligosaccharides) in the diet per day is 7g. In between the study arms there will be at least a 3 day washout period. Breath hydrogen will be measured hourly for 12 hours on the 2nd day of each study arm. Symptoms will be measured once daily at bed time each day. An oral enzyme supplement (alpha-galactosidase) in 2 doses or placebo will be given with each study arm. The supplement will be given three times daily (with each meal) for the 3 days of each study arm. The enzyme or placebo for each arm will be given in a random order to participants, but will include: *Placebo will be 2 glucose tablets. I.e. no dose. *Half dose will be 1 enzyme (containing 300 galU) and 1 glucose tablet. *Full dose will be 2 enzyme tablets (containing total 600 galU). Tablets will all look the same to aid in blinding. Participants will be asked to return their tablet containers to assist in monitoring adherence.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
People with Irritable Bowel Syndrome, as assessed by Rome III criteria, but otherwise well.
Exclusion criteria
*People with other diagnosed gastrointestinal disorders such as Coeliac Disease and IBD. *Non-hydrogen producers as shown on Fructan breath hydrogen test. *Women who are pregnant or breastfeeding. *Those with known food allergy likely to affect ability to follow study dietary protocol. *Those who have taken antibiotics, probiotics or prebiotics within the 4 weeks prior to the study. *Colonoscopy (bowel prep) within the past 4 weeks.
Outcome results
None listed