post-gastrectomy syndrome
Conditions
Interventions
Participants with a score of 4-7 on questionnaire item 5 (see Section 6.4.4, Assessment Items) will be defined as having flatus-related symptoms, whereas those with a score of 1-3 will be defined as n
Sponsors
Kindai University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants aged 18 years or older, regardless of sex Participants who underwent gastrectomy at our department, including distal gastrectomy, proximal gastrectomy, or total gastrectomy, and for whom at least 8 weeks have elapsed since surgery Participants who received an explanation of the study and provided written informed consent based on their own free will and sufficient understanding of the study procedures
Exclusion criteria
Exclusion criteria: Participants with a history of antibiotic treatment within 4 weeks prior to the initiation of oral BB536 intake Participants who routinely use medications for constipation (including osmotic laxatives, stimulant laxatives, bulk-forming laxatives, and epithelial function-modifying agents), antidiarrheal agents, or probiotic preparations Participants who routinely consume health foods or supplements containing lactic acid bacteria, bifidobacteria, oligosaccharides, dietary fiber, or similar products Participants who routinely use digestive enzyme supplements Participants with a known allergy to Bifidobacterium longum Participants who expressed unwillingness to participate in this study Participants judged by the principal investigator to be unsuitable for participation in this study for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of symptoms related to malodorous flatus (score for questionnaire item 5): This outcome will be evaluated in patients with flatus-related symptoms. Symptom improvement will be defined as a decrease in the score for questionnaire item 5 from 4-7 points at enrollment to 1-3 points at 4 weeks after enrollment. The improvement rate will be defined as the proportion of patients who achieved symptom improvement among the total number of patients analyzed in each group (BB536 intervention group and non-intervention group). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes Secondary outcomes will be evaluated in patients with flatus-related symptoms. Baseline is defined as the time of study enrollment, and 4 weeks after enrollment is defined as 4 weeks after the initiation of BB536 intake or the start of the observation period. Using the modified PGSAS-37 questionnaire, changes in the score for flatus-related symptoms (item 5), changes in the mean score of all items excluding item 5, and changes in the mean scores of the subscales (indigestion, diarrhea, and constipation) will be evaluated. Mean scores will be calculated by dividing the sum of the relevant item scores by the number of items. Scores at 4 weeks after enrollment will also be evaluated. In the BB536 intervention group, the modified PGSAS-37 questionnaire will additionally be administered at 8 and 12 weeks after enrollment to evaluate the sustainability of symptom improvement. Exploratory Outcomes Stool samples will be collected from both symptomatic and asymptomatic participants for gut microbiota analysis. Relative abundance of bacterial taxa, alpha diversity (faith_pd, Shannon, chao1, evenness, observed_otus), and beta diversity (bray_curtis, jaccard, unweighted_unifrac, weighted_unifrac) will be calculated. Principal coordinate analysis (PCoA) will also be performed, and the top three PCoA scores will be obtained. Furthermore, associations between gut microbiota indices and flatus-related symptom scores will be investigated._ | — |
Countries
Japan
Contacts
Public ContactNaoko Kounami
Kindai University Faculty of Medicine Department of Surgery
Outcome results
None listed