The goal of this clinical trial is to investigate whether a supplement containing the B. longum strain works to alleviate constipation in adults. The main questions it aims to answer are: Does a supplement containing the B. longum strain increase the number of spontaneous bowel movements per week, improve stool consistency, and enhance the quality of life? Participants will: Take a supplement containing the B. longum strain or a placebo every day for 8 weeks. Maintain an e-diary as per the instructions. Visit the clinic for screening assessments, baseline, and end of the intervention for stool sample submission.
Constipation significantly impacts the quality of life, and one of the main causes is the disruption of the gut microbiota. Probiotics have been reported to have a beneficial effect on the intestines, and Bifidobacteria, in particular, have shown functionality in relieving constipation.This randomized, placebo-controlled, clinical trial investigates the effect of Bifidobacterial supplementation intervention on bowel movement in healthy adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
On the first day of the intervention period, participants will be instructed to consume two capsules of the live B. longum strain daily with a glass of water before breakfast for the next eight weeks.
On the first day of the intervention period, participants will be instructed to consume two capsules, which are without any live bacteria, daily. They should take these before breakfast with a glass of water, for the following eight weeks.
Atlantia Clinical Trials
Chicago, Illinois, United States
Change in SBM frequency
Change in mean weekly frequency of SBM, as measured by the daily bowel diary from baseline to the end of intervention. Frequency will be defined as the mean weekly number of SBM during the 2-week run-in period prior to Visit 2, for baseline, and during the final 2-week period of the intervention prior to Visit 3, for end of intervention.
Time frame: From baseline to Week 8
Change in SBM frequency
Change in mean weekly frequency of SBM, as measured by the daily bowel diary from baseline to Week 6. Frequency will be defined as the mean weekly number of SBM from baseline to Week 1-2, baseline to Week 3-4, baseline to Week 5-6.
Time frame: From baseline to Week 2, Week 4 and Week 6
Change in stool consistency
Change in mean daily stool consistency as measured from the Bristol Stool Scale (BSS) in the daily bowel dairy from baseline to the end of intervention. Stool Consistency will be defined as the mean daily stool consistency during the 2-week run-in period prior to Visit 2, for baseline, and during the final 2-week period of the intervention, for end of intervention.
Time frame: From baseline to Week 8
Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire
Change in self-reported constipation related symptoms as assessed by the Total Score of the Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire.
Time frame: From baseline to Week 4 and Week 8
Patient Assessment of Constipation Quality of Life (PAC-QoL) Questionnaire
Change in self-reported impact of constipation on Quality of Life as assessed by the Total Score of the Patient Assessment of Constipation Quality of Life (PAC-QoL) Questionnaire.
Time frame: From baseline to Week 4 and Week 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.