| CTRI Number |
CTRI/2025/09/094103 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of a novel pre-probiotic formula in adults with GUT issues. |
|
Scientific Title of Study
|
A randomized, double-blind, controlled trial of a novel pre-probiotic formulation; assessing changes in GUT health in adults with GUT issues (Indigestion, Acidity, Bloating and Gas formation). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Y Rami Reddy |
| Designation |
Sr. Consultant, Gastroenterology |
| Affiliation |
Star Hospitals |
| Address |
STAR Hospitals, Survey No.74, Gastroenterology Department, Star Hospitals Room No 132, First Floor, Financial District, Nanakramguda, Hyderabad
Hyderabad
TELANGANA
500008
India |
| Phone |
9815192032 |
| Fax |
|
| Email |
yrrpgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Y Rami Reddy |
| Designation |
Sr. Consultant, Gastroenterology |
| Affiliation |
Star Hospitals |
| Address |
STAR Hospitals, Survey No.74, Gastroenterology Department, Star Hospitals Room No 132, First Floor, Financial District, Nanakramguda, Hyderabad
Hyderabad
TELANGANA
500008
India |
| Phone |
9815192032 |
| Fax |
|
| Email |
yrrpgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Y Rami Reddy |
| Designation |
Sr. Consultant, Gastroenterology |
| Affiliation |
Star Hospitals |
| Address |
STAR Hospitals, Survey No.74, Gastroenterology Department, Star Hospitals Room No 132, First Floor, Financial District, Nanakramguda, Hyderabad
Hyderabad
TELANGANA
500008
India |
| Phone |
9815192032 |
| Fax |
|
| Email |
yrrpgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| INU Energy Private Limited, Unit 2A/1 (Octave Block), Salarpuria Sattva Knowledge City, Madhapur, Shaikpet, Hyderabad, Telangana, India, 500081 |
|
|
Primary Sponsor
|
| Name |
INU Energy Pvt Ltd |
| Address |
5th Floor, Unit 2a/1 (octave Block), Salarpuria Sattva Knowledge City, Madhapur, Hyderabad, Telangana, India, 500081 |
| Type of Sponsor |
Other [For Profit 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 Y Rami Reddy |
STAR HOSPITALS |
Room No 132, Gastroenterology Department, First Floor, Financial District, Survey No.74, Nanakramguda, Hyderabad
Hyderabad
TELANGANA |
9815192032
yrrpgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| STAR HOSPITALS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
adults with GUT issues like Indigestion, Acidity, Bloating and Gas formation. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HAPPY GUT |
Moderate Happy Gut Sachet (1g), Each sachet contains a blend of Pre & Probiotic formula and Excipients.
Duration of treatment – 30 days.
Mode of administration - per-oral, powder dissolved in water.
Intervention compliance will be assessed by measuring the returned sachets of the product.
|
| Comparator Agent |
PLACEBO |
Placebo Sachet (1g), Each sachet contains Maltodetxrin (450 mg) and Excipients.
Duration of treatment – 30 days.
Mode of administration - per-oral, powder dissolved in water.
Intervention compliance will be assessed by measuring the returned sachets of the product.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male and females aged 25 to 65 years.
Self-reported history of GUT issues like Indigestion, Acidity, Bloating and Gas formation.
Participants who can provide informed consent.
|
|
| ExclusionCriteria |
| Details |
History of hypersensitivity to any of the investigational product, excipients, or Any known food allergies.
Small Intestinal Bacterial Overgrowth or carbohydrate intolerances.
Pre-existing medical condition or taking medication known to influence digestion and absorption of nutrients.
Any clinically relevant abnormal findings which, in the opinion of the investigators, may put participant at risk of adverse events including: Physical examination; Clinical chemistry; Haematology; Vital signs
History of diagnosis of gastrointestinal disease, inflammatory bowel disease, or functional gastrointestinal disorders, previous gastrointestinal surgery (intestinal resection, gastric bypass, colorectal surgery) or experiencing dysphagia
Systemic lupus erythematosus, cancer, thyroid disease, renal disease, hepatic disease, or uncontrolled metabolic disease
Individuals taking probiotics, antibiotics, fibre supplements, antacids, proton pump inhibitors, stool softeners or laxatives at time of recruitment or within the previous four weeks
Has any allergies or past reactions to ingredients in treatment and placebo
Pregnancy or nursing of an infant
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the GUT issues (Indigestion, Acidity, Bloating and Gas formation), assessed through structured interviews at baseline & day 30, Assessed using 15 point gastrointestinal symptom rating scale (GSRS) scale. |
Day 0, Day 15 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Digestion-associated Quality of Life Questionnaire (DQLQ). |
(Day 0 Vs Day 15 Vs Day 30) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "43"
Final Enrollment numbers achieved (India)="43" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/09/2025 |
| Date of Study Completion (India) |
06/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
Probiotics, as defined by the World Health Organization, are live microorganisms that, when administered in adequate amounts, provide a health benefit. They are believed to compete metabolically with pathogens, thereby strengthening the intestinal mucosal barrier and modulating the intestinal inflammatory environment. While probiotics can help restore intestinal microbial balance and gut homeostasis, definitive evidence supporting their efficacy in improving functional gastrointestinal disorders (FGIDs) remains limited.
A novel pre-probiotic blend has been developed for symptom management in FGIDs. Clinical trials have shown that administration of these bacteria, whether individually, in multi-strain blends, or combined with other probiotics and/or prebiotics, improves diarrhea, abdominal pain, bloating, and constipation in FGIDs. This particular combination of strains, administered together, is unique and has not been previously studied. The primary goal of this randomized, placebo-controlled clinical trial was to assess the safety and efficacy of this novel pre-probiotic blend in patients experiencing FGIDs.
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