Clinical Trial: A 52-week pilot study to evaluate the effects of GoGut Microbebiotic™ on body weight on healthy obese female patients.
- There were 2 protocols, one for women and one for men, designed as a pilot program to determine the effects of GoGut Microbebiotic™ on body weight and waist circumference. It was also intended to monitor for side effects of the study treatment as well as other exploratory end points.
Summary of Study Design
- This was a single-site trial involving healthy obese male and female subjects 18 years of age and older with a BMI of > 30. Subjects came in every 2 weeks for 52 weeks to determine compliance and capture adverse events. The subjects were taking 10g of GoGut Microbebiotic™ three times a day (TID) with each meal. Subjects had blood pressure measured, BMI calculated, waist measured, physical exam, and safety labs during office visits.
Female Weight Results
- There were a total of 20 subjects who participated and deemed compliant with study requirements*. Of the 20 subjects, 50% (which will be referred to as “Responders”) had a weight reduction. Among the Responders, there was an average weight loss of 32.2 lbs. which translated into an 11.5% decrease in body weight (average weight was 279.2lbs). Even taking into account both Responders and Non-Responders, there was an average weight loss of 8.8 lbs or 3.4% reduction of body weight (average weight 259.5).
- Waistline Measurements: Among all 20 female subjects, 70% showed a reduction in waist circumference. The average decrease of all subjects was 3.4 inches and in the Responder group (weight loss), there was a decrease of 6.5 inches.
- Of all the subjects, 83% (39/47) either lost weight, inches, or both. Almost all subjects reported increase in energy and improved mood. About half reported that they had better quality of sleep, saying that they felt they were getting a more restful night sleep.
- Adverse Events: Most of the male and female subjects reported having intestinal gas (flatulence), feeling bloated, and minor abdominal cramps the first 2-3 weeks (visit 3) of taking the study treatment. This mostly went away by the 4th week (visit 4). However, there was only one subject who continued to have gastrointestinal symptomatology throughout the study but this was not concerning to her.
* If subject did not complete the 52 weeks the final visit was used in calculations.