A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of prebiotic colon detox shots in promoting digestive health and gut function.
Overview
- Phase
- Phase 2/3
- Status
- Completed
- Sponsor
- Seven Turns Pvt. Ltd.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 1. Gastrointestinal Symptom Rating Scale GSRS Assessment of symptoms including bloating, abdominal pain, diarrhea, and constipation, abdominal discomfort using a 7 Likert scale
Overview
Brief Summary
The rationale for conducting the proposed study on the efficacy and safety of prebiotic supplementation in individuals depend on several factors. The gut microbiota, once established, undergoes dynamic changes throughout a person’s life. Despite its variability, alterations in gut microbiota composition have profound implications for the development of various diseases, ranging from chronic gastrointestinal disorders to neurological conditions (55). It is important to evaluate gut microbiota composition and its relationship with the human health–disease condition, as well as the effect of consumption of prebiotic supplement on the balance of its composition. There is growing evidence suggesting that alterations in the gut microbiota composition (dysbiosis), may give rise to various digestive issues such as irritable bowel syndrome, constipation, diarrhea, heartburn, or bloating.
The prevalence of GI diseases has increased in recent years, largely attributed to significant lifestyle changes. Studies have revealed a strong association between GI disorders and mental health issues, including depression, stress, anxiety, and impaired central nervous system function (56). While dietary interventions are a cornerstone of gut health and inflammation management, long-term success is often challenging to achieve. Therefore, exploring adjunct approach such as prebiotic and gut detox supplementation could offer additional strategies for improving gut detoxification and digestion, potentially influencing metabolic outcomes. Boosting the beneficial bacteria in the digestive tract and gut detoxification help to provide relief from digestive issues. Undergoing gut cleansing i.e. detoxification improves digestion, repairs existing damage to the intestines and restore healthy intestinal function.
Moreover, evaluating the safety of prebiotic supplementation is essential particularly in gut health and inflammation management where individuals may have underlying health conditions or be taking multiple medications. If interventional supplement is found to be effective and safe alternative, they could be incorporated into treatment protocols of various gastric disorders, offering participant s additional options for achieving and maintaining digestive health.
Overall, this randomized, double-blind, placebo-controlled clinical trial investigating the efficacy of prebiotic colon detox shots would fill a significant knowledge gap in the field of digestive health and gut function. The findings could contribute to a better understanding of the population health burden associated with digestive diseases and inform the development of strategies to reduce the overall disease burden. The major goals of the investigational product are to reduce inflammation, support gut health, and improve digestion by removing inflammatory foods and replacing them with nourishing, digestible options. Additionally, the product seeks to consolidate the positive changes achieved during the cleanse by promoting long-term gut health through balanced nutrition and healthy lifestyle practices.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Males and females aged 20-45 years, with an equal gender distribution (both inclusive);2.Female participants will be screened within 2 days of completion of the menstrual phase (bleeding phase).
- •A 7-day screening period will follow to ensure eligibility.
- •Treatment will begin immediately after the screening period is completed.
- •3.Participants must report one or more gut health-related symptoms, indicated by a GSRS score of 3-5 or a BSFS score of 1-
- •Eligible symptoms include:•Bloating •Abdominal discomfort or pain •Infrequent bowel movements (fewer than three defecations per week) •Hard or lumpy stools (types 1 to 3 on the Bristol Stool Form Scale) •Sensation of incomplete evacuation during defecation.4.Participants in whom loose stools are rarely present without the use of laxatives;5.Participants on stable medication for the past three months (with no worsening of symptoms or hospitalization) are eligible, or may be enrolled at the discretion of the investigator;6.Participants should agree to undergo Liver Function Tests and C-reactive protein assessments;7.Willingness to undergo baseline and follow-up assessments of gut health using the GSRS;8.Participants providing voluntary, written informed consent to participate in the study.
Exclusion Criteria
- •1.Participants with a diagnosis of colonic inertia; 2.Participants with a history of surgical interventions within the last six months; 3.History of anorectal surgery; 4.Participants diagnosed with functional gastrointestinal disorders including Functional Constipation Irritable Bowel Syndrome (IBS) Inflammatory Bowel Disease (IBD) or chronic diarrhea; 5.Participants with structural abnormalities such as rectal prolapse, rectocele, or anorectal stricture; 6.Participants with untreated or uncontrolled systemic conditions, including HIV or diabetes mellitus or tuberculosis; 7.Participants with renal or liver dysfunction; 8.Participants with neurological disorders, such as Parkinsons disease or multiple sclerosis; 9.A medical history of hypothyroidism, Grade 2 obesity, morbid obesity, or constipation associated with premenopausal or postmenopausal status; 10.Participants currently using laxatives, antacids, proton pump inhibitors, antibiotics, or other probiotic products; 11.Participants using herbal supplements, dietary fiber, or phytonutrient supplements; 12.Participants will be excluded if they have initiated new micronutrient supplements eg iron, zinc within the past 14 days; 13.Participants who have undergone colonic cleansing in the last three months; 14.Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study; 15.Participants with a history of substance abuse or heavy use of alcohol and drugs or tobacco use, where participants smoke more than 1or 2 pack per day; 16.Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant.
Outcomes
Primary Outcomes
1. Gastrointestinal Symptom Rating Scale GSRS Assessment of symptoms including bloating, abdominal pain, diarrhea, and constipation, abdominal discomfort using a 7 Likert scale
Time Frame: 1. At day 1, day 4, day 8, and day 15. | 2. a. At screening, day 1, day 4, day 8, and day 15. | b. At day 1, day 4, day 8 and day 15. | 3. At day 1, day 4, day 8, and day 15.
Up to three loose stools or bathroom visits per day will be recorded as no to minor discomfort on the GSRS. If the number of loose stools or visits exceeds three, the severity of discomfort will be assessed and scored at the discretion of the investigator.
Time Frame: 1. At day 1, day 4, day 8, and day 15. | 2. a. At screening, day 1, day 4, day 8, and day 15. | b. At day 1, day 4, day 8 and day 15. | 3. At day 1, day 4, day 8, and day 15.
2. Stool Consistency and Frequency
Time Frame: 1. At day 1, day 4, day 8, and day 15. | 2. a. At screening, day 1, day 4, day 8, and day 15. | b. At day 1, day 4, day 8 and day 15. | 3. At day 1, day 4, day 8, and day 15.
a. Bristol Stool Form Scale BSFS Evaluating stool consistency
Time Frame: 1. At day 1, day 4, day 8, and day 15. | 2. a. At screening, day 1, day 4, day 8, and day 15. | b. At day 1, day 4, day 8 and day 15. | 3. At day 1, day 4, day 8, and day 15.
b. Frequency of Bowel Movements Self-reported daily bowel movements recorded using a bowel diary
Time Frame: 1. At day 1, day 4, day 8, and day 15. | 2. a. At screening, day 1, day 4, day 8, and day 15. | b. At day 1, day 4, day 8 and day 15. | 3. At day 1, day 4, day 8, and day 15.
3. Time of Evacuation Documenting the duration of each bowel movement using a bowel diary
Time Frame: 1. At day 1, day 4, day 8, and day 15. | 2. a. At screening, day 1, day 4, day 8, and day 15. | b. At day 1, day 4, day 8 and day 15. | 3. At day 1, day 4, day 8, and day 15.
Secondary Outcomes
- The secondary objectives will be to evaluate the impact of prebiotic colon detox shots on detoxification, and systemic inflammation related to gut health, digestive function, and quality of life.(Additionally, the study will assess safety through monitoring adverse events, tolerability, and compliance throughout the study duration.)
Investigators
Dr Ketan Kshirsagar
Sangvi Multispeciality Hospital Pvt. Ltd