Plain language summary
Probiotics have been found to have beneficial effects in adults with functional gastrointestinal (GI) disorders, however little evidence exists regarding its effects on healthy adults. The aim of this prospective, randomised, double-blind, placebo-controlled, parallel-group trial was to clarify the beneficial effects of Bifidobacterium bifidum (B bifidum) on gastric symptoms in 100 healthy Japanese adults who experience temporary GI symptoms. Participants were randomised to consume active fermented milk or placebo milk matched for colour, taste and packaging daily for four weeks and various qualitative and quantitative measurements were assessed. This trial found the group consuming B bifidum experienced significantly better relief from upper GI symptoms compared with the placebo group. These findings suggest daily consumption of milk fermented with B bifidum helps relive GI discomfort and symptoms in healthy adults with no risk of side effects. Based on these results, the authors conclude fermented milk drinks can be recommended to patients who experience temporary GI pain.
Abstract
In a preliminary open-label trial by our group, Bifidobacterium bifidum YIT 10347 (YIT10347) relieved gastric symptoms in patients with functional gastrointestinal disorders. Hence, in this study, we investigated the effects of YIT10347 on gastrointestinal symptoms in healthy adults. In this prospective double-blind, randomized, placebo-controlled trial (UMIN000024654), 100 healthy Japanese adults were randomly assigned to a YIT10347 group or placebo group and consumed 100 mL of YIT10347-fermented milk or placebo fermented milk, respectively, every day for 4 wk. Gastrointestinal symptoms were evaluated by using the modified Frequency Scale for Symptoms of Gastroesophageal Reflux Disease (m-FSSG) and Gastrointestinal Symptom Rating Scale (GSRS) as primary endpoints. Mental symptoms, quality of life, salivary stress markers, and gastric emptying were evaluated as secondary endpoints. Effectiveness and safety were analyzed in a per-protocol set (YIT10347 group, n = 39; placebo group, n = 40) and full analysis set (YIT10347 group, n = 50; placebo group, n = 50), respectively. In the m-FSSG evaluation, the YIT10347 group had a significantly higher relief rate of postprandial discomfort and greater changes in postprandial epigastric pain score from baseline than the placebo group. In the GSRS evaluation, the YIT10347 group had significantly higher relief rates of overall gastrointestinal symptoms, upper gastrointestinal symptoms, flatus, and diarrhea than the placebo group. We detected no significant differences in scores or relief rates of mental symptoms and quality of life, a salivary stress marker, or gastric emptying between the 2 groups. No severe adverse events associated with test beverage consumption were observed in either group. These findings suggest that daily consumption of YIT10347-fermented milk exerts beneficial effects on gastrointestinal discomfort and symptoms such as postprandial discomfort and epigastric pain in healthy adults.
Methodological quality
Jadad score
:
5
Allocation concealment
:
Yes
