| CTRI Number |
CTRI/2024/10/075864 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study to check effectiveness of prebiotic colon detox shots in management of digestive health. |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of prebiotic colon detox shots in promoting digestive health and gut function. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/24-25/034 Version 1.00,dated 26th Sept 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ketan Kshirsagar |
| Designation |
Principal Investigator |
| Affiliation |
Sangvi Multispeciality Hospital Pvt. Ltd |
| Address |
Sangvi Multispeciality Hospital,
OPD room no 01,1st floor,Krushna Chowk, Krushna Nagar,
New Sangvi
Pune MAHARASHTRA 411027 India |
| Phone |
9049002749 |
| Fax |
- |
| Email |
drketan.sangvihospital@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Abhishek Kanade |
| Designation |
Senior Manager-Research and Product Development |
| Affiliation |
Seven Turns Pvt. Ltd. |
| Address |
Seven Turns Pvt Ltd - The Good Bug 204, Naman Midtown Tower A, Senapati Bapat Marg, Prabhadevi West
Mumbai MAHARASHTRA 400013 India |
| Phone |
7776018666 |
| Fax |
- |
| Email |
dr.abhishek@seventurns.in |
|
Details of Contact Person Public Query
|
| Name |
Kaynat Mirajkar |
| Designation |
Lead-Nutrition, Regulatory and Medical Affairs |
| Affiliation |
Seven Turns Pvt. Ltd. |
| Address |
Seven Turns Pvt Ltd - The Good Bug 204, Naman Midtown Tower A, Senapati Bapat Marg, Prabhadevi West
Mumbai MAHARASHTRA 400013 India |
| Phone |
9699384096 |
| Fax |
- |
| Email |
kaynat@seventurns.in |
|
|
Source of Monetary or Material Support
|
| Seven Turns Pvt. Ltd. The Good Bug
204, Naman Midtown Tower A, Senapati Bapat Marg, Prabhadevi West, Mumbai, Maharashtra 400013 |
|
|
Primary Sponsor
|
| Name |
Seven Turns Pvt. Ltd. |
| Address |
204, Naman Midtown Tower A, Senapati Bapat Marg, Prabhadevi West, Mumbai, Maharashtra 400013 |
| Type of Sponsor |
Other [Nutraceutical Marketing company ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ketan Kshirsagar |
Sangvi Multispeciality Hospital Pvt. Ltd |
OPD room no 01, 1st floor,Krushna Chowk, Krushna Nagar,
New Sangvi Pune MAHARASHTRA |
9049002749 - drketan.sangvihospital@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sangvi Multispeciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: Prebiotic Colon Detox Shots |
70ml to be taken first thing in the morning on an empty stomach for 14 days. |
| Comparator Agent |
Group B: Placebo |
70ml to be taken first thing in the morning on an empty stomach for 14 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
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 1-3. 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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Gastrointestinal Symptom Rating Scale GSRS Assessment of symptoms including bloating, abdominal pain, diarrhea, and constipation, abdominal discomfort using a 7 Likert scale
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.
2. Stool Consistency and Frequency
a. Bristol Stool Form Scale BSFS Evaluating stool consistency
b. Frequency of Bowel Movements Self-reported daily bowel movements recorded using a bowel diary
3. Time of Evacuation Documenting the duration of each bowel movement using a bowel diary
|
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 Outcome
|
| Outcome |
TimePoints |
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.
|
From Screening to end of the study.
|
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "63"
Final Enrollment numbers achieved (India)="63" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/10/2024 |
| Date of Study Completion (India) |
01/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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. RESULTS A
total of 63 participants completed the study and were included
in the final analysis (intervention: n=32; placebo: n=31). Baseline demographic
and clinical characteristics were comparable between groups. CONCLUSION
In
this randomized, double-blind, placebo-controlled trial, a 14-day
prebiotic–botanical formulation resulted in clinically
meaningful improvements in gastrointestinal symptoms, bowel habits, and
gastrointestinal-related quality of life in adults with mild
functional digestive complaints. By Day 15, the intervention produced
approximately 70–80% improvement in validated symptom scores,
including pronounced reductions in bloating, abdominal pain, reflux, and
indigestion, with good tolerability and no safety concerns. These findings
support the short-term use of the formulation as a non-pharmacological
approach for digestive symptom relief and bowel function support.
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