Effect of a novel pre-probiotic formula in adults with GUT issues.

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).

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094103

Enrollment

Registered

2025-09-02

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 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,

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.Timepoint: Day 0, Day 15 and Day 30	—

Secondary

Measure	Time frame
Improvement in Digestion-associated Quality of Life Questionnaire (DQLQ).Timepoint: (Day 0 Vs Day 15 Vs Day 30)	—

Countries

India

Contacts

Public ContactDr Y Rami Reddy

Star Hospitals

yrrpgi@gmail.com9815192032

Outcome results