Clinical trial to study the effects of Galactooligosachharides (GOS) added gummies in the Teaching Staff with Functional Constipation

Presence of Functional Constipation inthe Teaching Staffof The M. S. University of Baroda and Impact Evaluation of Supplementation of Galactooligosachharides (GOS)added Gummies on their Constipation Profile and Gut Health

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037474

Enrollment

Registered

2021-10-22

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

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

Conditions

Health Condition 1: K928- Other specified diseases of the digestive system

Interventions

Intervention1: Galactooligosachharide: Galactooligosachharide 10 g OD for 30 days Control Intervention1: Standard sugar gummies: Standard sugar gummies 10g OD for 30 days

Eligibility

Inclusion criteria

Inclusion criteria: Duration: Symptoms >6 months (As per Rome IV Criteria) Age group: 25-60 years Fecal Calprotectin levels >50 microgram

Exclusion criteria

Exclusion criteria: (1) prior intestinal resection; (2) patient history of GI diseases like hiatal hernia, gastroesophageal reflux disease (GERD), fissures and hemorrhoids; (3) antibiotic use within the last 12Â weeks prior to enrollment; (4) regular use of NSAIDs (Eg: aspirin) (5) excessive alcohol intake (more than two drinks for men and one drink for women daily); (6) presence of chronic metabolic disease such as symptomatic cardiovascular disease, uncontrolled diabetes, current active treatment of cancer; (7) consumption of probiotics, prebiotics, or synbiotics on a regular basis (8) 60 years (9) Pregnant women

Design outcomes

Primary

Measure	Time frame
1. Extent of presence of constipation 2. Intake of GOS added gummies will Improve the constipation profile of the subjects Timepoint: 1. Baseline 2. Baseline and 4 weeks	—

Secondary

Measure	Time frame
1. Relief from depression 2. Feasibility & Acceptability of GOS gummies as a supplement 3. Improving Chrono nutrition Profile & Quality of Life 4. Improving the colonization of probiotics (Bifidobacteria and Lactobacillus) and reduction in the colonization of E.coli in the gut)Timepoint: 1. Relief from depression- 30 days 2. Feasibility & Acceptability of GOS gummies as a supplement- 15 days 3. Improving Quality of Life- 30 days 4. Improving the colonization of probiotics (Bifidobacteria and Lactobacillus) and reduction in the colonization of E.coli in the gut)- 30 days	—

Measure

Time frame

1. Relief from depression 2. Feasibility & Acceptability of GOS gummies as a supplement 3. Improving Chrono nutrition Profile & Quality of Life 4. Improving the colonization of probiotics (Bifidobacteria and Lactobacillus) and reduction in the colonization of E.coli in the gut)Timepoint: 1. Relief from depression- 30 days 2. Feasibility & Acceptability of GOS gummies as a supplement- 15 days 3. Improving Quality of Life- 30 days 4. Improving the colonization of probiotics (Bifidobacteria and Lactobacillus) and reduction in the colonization of E.coli in the gut)- 30 days

—

Countries

India

Contacts

Public ContactMs Kankona Dey

The Maharaja Sayajirao University of Baroda

mini.sheth-fn@msubaroda.ac.in8780680784

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 10, 2026