This study was a prospective randomized clinical study. There was interventional treatment for a total of 8 weeks including a 2-week washout period. The subjects attended four appointments in the clinic throughout the duration of the study. Study Primary Objective: • To assess improvement in bloating symptoms Study Secondary Objectives: * To assess safety and tolerability of the formulation * To compare the time taken for perceptual improvement in bloating/distention * Enzyme blood assays * To assess quality of life indices
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
85
Eligible subjects will receive Placebo to take daily for six weeks
Eligible subjects will receive Active supplement to take daily for six weeks
See Final Report
San Francisco, California, United States
Changes in Digestive Quality of Life Questionnaire (DQLQ) scores
To assess changes in scores related to bloating, diarrhea, constipation and heartburn on quality-of-life indicators, comparing active supplement to placebo group
Time frame: from enrollment to end of study at 8 weeks
Changes in Symptom Severity Score (Diary)
Patients filled out the symptoms diary that had questionnaires of bowel habits. Abdominal pain and bloating were rated on a 100-point visual analogue scale with 0=none and 100=severe, comparing active supplement to placebo group
Time frame: from enrollment to end of study at 8 weeks
Changes in Gastrointestinal Short Form Questionnaire (GSFQ) Scores
To assess changes in gastrointestinal symptoms comparing active supplement to placebo group
Time frame: from enrollment to end of study at 8 weeks
Changes in Stool Consistency (Bristol Stool Scale)
Daily stool consistency ratings will provide data on changes in bowel health and regularity. Average stool consistency scores will be compared across baseline, active treatment, and placebo phases.
Time frame: from enrollment to end of study at 8 weeks
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