None listed
Conditions
Brief summary
Current therapy for irritable bowel syndrome is suboptimal. Recent studies have suggested that small intestinal bacterial overgrowth may be present and that its treatment may have therapeutic benefit. The primary aim is to examine whether the effect of Yakult on a breath hydrogen test feature of bacterial overgorwoth that was seen in the pilot study is reproducible and specific to the study treatment, or just a chance observation. The secondary aims were to define the effect of Yakult on the rate at which the stomach empties, to compare the effects on gut symptoms of Yakult, placebo and Yakult withdrawal, and to examine the association of change in breath test patterns with changes in gut symptoms. In addition, because bacterial overgrowth is said to be causally associated with fructose malabsorption, another aim is to examine the effect of Yakult and the changes in breath test patterns with changes in fructose absorption and malabsorption. The major study hypotheses are that Yakult corrects small intestinal bacterial overgrowth and that this correction is associated with improvement in symptoms of irritable bowel syndrome
Interventions
Lactobacillus casei Shirota strain (Yakult)
65 ml once per day during the randomised placebo-controlled phase - duration 6 weeks
Upon completion, subjects will be offered 65 ml per day Yakult for 6 weeks.
During the withdrawal phase (6 weeks), no therapy is given (observation only)
Sponsors
Box Hill Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ERBHAL, defined as a rise of breath hydrogen of 10 ppm or greater above baseline breath hydrogen on two consecutive 15-minute samples before 90 minutes following ingestion of lactulose; 2. Irritable bowel syndrome according to Rome III criteria; 3. On no specific medication for irritable bowel syndrome 4. On a stable diet for the four weeks prior to entering the study and during the study; 5. Able to maintain current drug therapy for functional gut symptoms without change in drugs or dose during the study; 6. Able to give written, informed consent
Exclusion criteria
1. treatment for greater than two weeks with any probiotic within the previous 3 months; 2. any antibiotic therapy in the previous two months; 3. excessive alcohol intake 4. clinically significant co-morbidity
Outcome results
None listed