Effect of Chitosan Consumption on Improving Clinical Symptoms and Quality of Life in Patients with Irritable Bowel Syndrome

Evaluation of the effect of chitosan consumption in improving the clinical symptoms and quality of life in irritable bowel syndrome (IBS) patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250223064828N1

Enrollment

100

Registered

2025-03-01

Start date

2025-03-10

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Irritable bowel syndrome. Irritable bowel syndrome

Interventions

Intervention 1: Intervention group: The group receiving chitosan capsules produced by Karen Company will take 2 capsules of 500 mg daily (before meals) for 3 months. Intervention 2: The placebo, which

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients aged between 18 and 70 years Confirmed diagnosis of Irritable Bowel Syndrome (IBS) based on ROME IV criteria

Exclusion criteria

Exclusion criteria: History of major gastrointestinal diseases (e.g., Inflammatory Bowel Disease (IBD), celiac disease, enzymatic deficiencies) History of major abdominal surgery Pregnancy or lactation Known hypersensitivity to antibiotics Concurrent major systemic diseases (e.g., malignancy, liver failure, kidney failure, diabetes mellitus, scleroderma) Active organic gastrointestinal disease Family history of colorectal carcinoma or IBD Use of immunosuppressants or chronic steroid therapy in the past 6 months

Design outcomes

Primary

Measure	Time frame
Quality of Life. Timepoint: At the beginning of the study (before the intervention) and 3 months after starting chitosan consumption. Method of measurement: A questionnaire that includes questions regarding the quality of life (Quality of Life) of IBS patients.;Clinical signs. Timepoint: At the beginning of the study (before the intervention) and 3 months after starting chitosan consumption. Method of measurement: ROME IV questionnaire and World Gastroenterology Organization questionnaire for the diagnosis of irritable bowel syndrome.	—

Measure

Time frame

Quality of Life. Timepoint: At the beginning of the study (before the intervention) and 3 months after starting chitosan consumption. Method of measurement: A questionnaire that includes questions regarding the quality of life (Quality of Life) of IBS patients.;Clinical signs. Timepoint: At the beginning of the study (before the intervention) and 3 months after starting chitosan consumption. Method of measurement: ROME IV questionnaire and World Gastroenterology Organization questionnaire for the diagnosis of irritable bowel syndrome.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Razmkhah

Ahvaz University of Medical Sciences

fati.rzm1371@gmail.com+98 61 3320 4574

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026