Gut Health and the Effect on Substance and Alcohol Cravings
Phase: EARLY_PHASE1
Conditions: Craving
Sponsor: City Rescue Mission Medical Clinic

Gut Health and the effect on substance and alcohol cravings 
 
 
 
 
 
8/10/23 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
Study Protocol and Statistical Analysis Plan 
 
This protocol is designed to evaluate substance, including alcohol, cravings before and 
after gut health intervention. Consent and a pre survey on cravings will be collected.  
Then participants will take a probiotic/prebiotic and a pickle for 30 days.  After 30 days 
the same survey will be taken by the participants and a paired t test will be used to 
analyze if there is a statistical change in cravings. 
Sample size: The total number of individual subjects is expected to reach approximately 
30-40 participants. The sample size is based on a compromise of time, cost and 
feasibility for a pilot study.  
Study population : The study population will be representative of adults at least 18 years 
of age to 75 years of age, male and females who have alcohol or substance cravings.  
Inclusion and exclusion criteria have been listed elsewhere.  
 
This is a pilot study with quantitative research and experimental design. 
The same survey will be used at the start of the study and at the end.  The results of the 
data will be compared using a paired t-test.