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Completed
NCT07902882
A Clinical Trial to Examine the Effects of Gut Health Supplements to Improve Gut and Digestive Health and Function
Conditions: Bloating, Digestive Discomfort, Irritable Bowel Syndrome (IBS), Flatulence, Constipation, Gut Health
Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: JS Health & Vitamins
Location: Citruslabs Las Vegas Nevada
Summary
This is a double-blind, randomized, placebo-controlled trial evaluating the efficacy of JSHealth's Debloat \& Detox supplement, used alone or in combination with their Probiotics supplement, on gut and digestive health and function in 60 female participants aged 18-45 with self-reported bloating and digestive discomfort.
Participants will be randomly assigned to either the intervention or placebo group for eight weeks. During the first four weeks, intervention participants will take the Debloat \& Detox supplement and placebo participants will take a corresponding placebo. During weeks five through eight, intervention participants will add the Probiotic supplement and placebo participants will add a probiotic placebo. Outcomes will be assessed via study-specific questionnaires and abdominal circumference measurements at Baseline, Day 1 (after first use), and at the end of Weeks 2, 4, 6, and 8.
Eligibility Criteria
Inclusion Criteria:
* Female aged 18-45.
* Have self-reported issues with bloating and digestive discomfort at least three times per week for the last three months.
* Willing to complete a two-week washout period of all other vitamins and supplements prior to starting the trial.
* Willing to maintain their standard dietary pattern, activity level, body weight, and sleep schedule for the duration of the study.
* Be generally healthy and not live with any uncontrolled chronic disease.
* Resides in the United States.
Exclusion Criteria:
* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* Previous diagnosis of liver disease or elevated liver enzymes.
* Anyone who is currently undergoing or planning to undergo any gut or weight-related procedures in the next six weeks.
* Anyone with any known allergies or hypersensitivities to any of the study product ingredients.
* Anyone who has taken any prescription medications or supplements (e.g., probiotics) targeting the gut or any antibiotics in the past three months or who plans to take any for the duration of the trial.
* Women who are pregnant, breastfeeding, or trying to conceive.
* Anyone unwilling to follow the study protocol.
* Anyone following any particular restrictive dietary regimen, such as a ketogenic diet or intermittent fasting.
* Anyone who has undergone any surgeries or invasive treatments in the past six months or who has any planned during the study period.
* Anyone with a history of severe digestive disorders including but not limited to Irritable Bowel Disease (IBD), ulcerative colitis (UC), Crohn's disease, stomach cancer, or gastrointestinal tract surgeries.
* Anyone who is currently enrolled in or planning to participate in another research study in the next six weeks.
* Anyone with a history of substance abuse.
Source: ClinicalTrials.gov (NCT07902882). StuddyBuddy aggregates publicly available trial information.