See Final Report
San Francisco, California, 94127, United States
NCT Number: NCT06808867
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
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
San Francisco, California, 94127, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Eligible subjects will receive Placebo to take daily for six weeks
Eligible subjects will receive Active supplement to take daily for six weeks
Time frame: from enrollment to end of study at 8 weeks
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
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
To assess changes in gastrointestinal symptoms comparing active supplement to placebo group
Time frame: from enrollment to end of study at 8 weeks
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.
Olly, PBC
Industry
A 6-week Randomized, Double-blind, Comparative Clinical Study of the Efficacy of an Oral Product in Subjects With Acid Reflux and/or Abdominal Bloating/Distention and Gastrointestinal Symptoms
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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